The American Society for Metabolic and Bariatric Surgery Clinical Issues Committee
Approved by the ASMBS Executive Council, May 2015
The following position statement is issued by the American Society for Metabolic and Bariatric Surgery in response to numerous inquiries made to the Society by patients, physicians, Society members, hospitals, health insurance payors, the media, and others, regarding the complication of gastrointestinal (GI) leak after primary stapled (laparoscopic or open) bariatric procedures, including gastric bypass (GB) and sleeve gastrectomy (SG). In this statement, a summary of current, published, peer-reviewed scientific evidence and expert opinion is presented and suggestions made regarding reasonable approaches to prevention, postoperative detection, and management of GI leaks. The intent of issuing such a statement is to provide available objective information about the complication of leaks after primary GB and SG procedures. The general principles of leak management herein may also apply to leaks occurring after stapled biliopancreatic diversion (BPD) and BPD with duodenal switch (DS) procedures; however, the paucity of procedure-specific literature for BPD and DS limits the value of this statement to those procedures. The statement is not intended as, and should not be construed as, stating or establishing a local, regional, or national standard of care. The statement will be revised in the future as additional evidence becomes available.
GI leak is a known complication after both GB and SG with a reported incidence, in large published case series of open and laparoscopic cases, between .1% and 8.3% after GB [1–11] and 0% and 7% after SG . In a large longitudinal study of 28,616 patients published in 2011, the incidence of leak after laparoscopic GB, laparoscopic SG, and open GB were reported to be .8%, .7%, and 1.5%, respectively, suggesting an overall decrease in the incidence of GI leak in recent years . Despite the apparent decreased incidence over time, GI leak remains an important cause of overall morbidity and mortality after primary stapled bariatric procedures. The etiology of GI leaks is multiple but generally falls into mechanical/tissue causes or ischemic causes, both of which involve intraluminal pressure that exceeds the strength of the tissue and/or staple line . Adherence to meticulous tissue handling, consideration of tissue thickness, and avoidance of inadvertent narrowing, undue tension, and twisting or kinking of the mesentery and tissues are believed to be important considerations when performing stapled bariatric procedures. The clinical presentation of GI leak may be more subtle or delayed in obese patients, relative to normal weight patients, making the very diagnosis of a GI leak challenging in many patients . Once signs and symptoms develop, prompt diagnosis and treatment of a leak may minimize the inflammatory and septic sequelae, although evidence suggests that the immunoreactivity of the host determines the endogenous inflammatory responsiveness to a greater extent than the timing of treatment alone . It is understood, therefore, that the development of secondary or tertiary complications, including death, can occur despite prompt and expeditious treatment of a GI leak.
The purpose of this position statement is to provide evidence-based findings on the prevention, detection, and management of GI leaks after GB and SG. The utilization of imaging techniques and surgical reexploration in the context of routine postoperative surveillance and suspected postoperative GI leak will be reviewed, as well as the utilization of nonoperative and endoscopic management.
Prevention of gastrointestinal leak
GI leaks after GB occur most often in one of 4 locations, including the gastrojejunal anastomosis, gastric pouch staple line, jejunojejunostomy, and gastric remnant staple line. The true incidence and morbidity of any of the leak locations are not known. The most commonly reported location for GI leak after GB is at the gastrojejunal anastomosis, although some have reported a greater mortality from jejunojejunostomy leaks . The majority of GI leaks seem to occur in the absence of a known technical error. Supporting this conclusion is the observation that leaks are reported to occur at some level of frequency in all reported large series of GB. Numerous intraoperative maneuvers have been suggested in an attempt to decrease the incidence of leak, including, but not limited to, oversewing the staple line and reinforcing the staple line with biologic or synthetic materials [16,17] such as fibrin glue or other tissue sealants [18–21].
There is no high-quality clinical evidence, including available prospective randomized studies, to suggest that any such interventions significantly decrease leak incidence after GB. These interventions, however, are associated with increased operative cost and, in certain circumstances, increased operative time. In a recent meta-analysis and systematic review on the use of staple line reinforcement (SLR) after GB, there was a finding of decreased risk of leak with use of SLR. However, the presence of heterogeneity and poor overall quality of detail in data from the included trials was a recognized weakness of the study, as acknowledged by the authors . Intraoperative leak assessment using endoscopy and/or distention of the anastomosis with dye, air, or other gas may be useful to detect leaks that can be repaired during the procedure, but these techniques have not been reported to decrease the risk of leak after surgery.
Identification of a “positive” intraoperative leak test, however, regardless of the type of test used, should warrant appropriate repair and retesting before completion of the operation. Whereas some surgeons advocate routine placement of drains in proximity to the gastrojejunal anastomosis to better diagnose and/or control leakage from this site during the postoperative period, or for conversion of a leak into a controlled fistula [20,23,24], others hypothesize that drains in proximity to an anastomosis are unnecessary  and may increase the risk of a leak developing, particularly if left in place more than a few days [26,27]. In summary, there is no high-level evidence to support mandated use of any of the above practices for the prevention or amelioration of a GI leak after GB.
Post‐operative leak detection
A hospital in which bariatric procedures are performed should have the capability of imaging by plain film, fluoroscopy, and computed tomography (CT). The size and weight capacities of current CT, fluoroscopy units, and magnetic resonance imaging (MRI) scanners will accommodate the majority of bariatric surgery patients. The weight limitations for CT and MRI scanners are provided by the manufacturer and range from 135–200 kg (300–450 lbs) . Of significance, a hospital’s warranty agreement for repair of expensive CT, fluoroscopy, and MRI equipment may be voided if the equipment is damaged by patients who weigh more than the manufacturers’ guidelines allow. Although CT machines that can accommodate patients of up to 350 kg weight (800 lbs) are commercially available, they are very expensive and therefore not routinely purchased by most hospitals. At this time, these scanners should not be considered a necessity for quality bariatric patient care, although surgeons performing bariatric surgery should be aware of the weight limitations of the radiology equipment in their facility because a subset of patients in a bariatric practice are likely to exceed the weight limitations of certain specialized imaging equipment, such as the CT or MRI machine.
Withholding surgical treatment for obesity from the highest weight subgroup of patients may not be sound clinical judgment because many series report acceptably low-risk treatment of super-obese patients [29–33]. These patients are in the highest need of surgical weight loss, and the decision to proceed with bariatric surgery should be a clinical judgment made by the surgeon based on patient risk factors for treatment weighed against the risks of failing to provide successful weight reduction treatment to an individual patient. The capabilities of the facility, the capabilities of nearby facilities, and the patient’s wishes should all be included in the surgeon’s judgment regarding acceptance of a patient for surgery. A patient should not be rejected for surgical treatment based solely on the fact that the patient exceeds the weight standards or gantry limitations of a hospital’s CT or MRI imaging equipment.
Routine post‐operative radiologic assessment for leak
Routine postoperative upper GI (UGI) contrast studies are performed by many surgeons to detect leaks , but there is evidence to support selective, rather than routine, contrast studies after gastric bypass [35–39]. Information can provided by routine UGI contrast studies regarding anastomotic narrowing, edema or stricture of both the gastrojejunal anastomosis and jejunojejunostomy, abnormal dilation of the gastric remnant, and other causes of early postoperative bowel obstruction, such as internal hernia or trocar site hernia, that can be useful and may influence subsequent care . Based on current evidence, however, the decision to perform routine versus selective UGI contrast studies to assess for a GI leak should be left to the discretion of surgeons on the basis of their experience, on factors related to the system of care in place, and on other characteristics of the patient and the population being treated.
Radiologic evaluation versus exploration for suspected leak
UGI contrast studies are used by many surgeons to evaluate gastrojejunostomy in patients with a suspected leak after GB. The first consideration to proceeding with any type of radiologic evaluation is the clinical stability of the patient. Radiologic evaluation is not appropriate for unstable patients, and prompt surgical exploration (open or laparoscopic) should be initiated. Numerous factors may influence the accuracy of fluoroscopic testing, including patient-related factors (the ability to stand, balance, and move; the ability to swallow; and the size of the patient) and factors related to the system of care in place (experience of the radiologist with bariatric patients and procedures, capabilities of the facility). Among reports, sensitivity of upper GI contrast examination varies between 22% and 75% [2,37,41]. CT of the abdomen after GB can detect leaks, abscesses, and bowel obstruction, and may be better able to discern suspected leaks of the jejunojejunostomy and/or remnant stomach . CT may also be better able to discern whether a leak appears “contained” or “freely” communicating within the abdominal cavity . In addition, CT of the chest has become a mainstay of evaluation for pulmonary embolism, pneumonia, and effusion, which can be in the differential diagnosis when assessing a patient for possible leak [43,44]. Inclusion of the chest during CT of the abdomen has not been found to delay treatment or increase morbidity and therefore may be considered when an abdominal CT is being obtained for evaluation of a GI leak.
There are inherent limitations of CT imaging in the obese patient, and patient weight has a profound effect on the magnitude of enhancement by intravenous (IV) contrast material both in the vascular system and in parenchymal organs such as the liver . Additionally, patient positioning and the inability to ingest adequate oral contrast are important limitations in this population. The experience of the radiologist in interpreting postoperative GB anatomy also plays an important role. These limitations may lead to false negative results. CT has not consistently been found to have a high level of sensitivity in detecting early postoperative leaks in this patient population. When a UGI and CT are combined, up to one third of patients will have both studies interpreted as normal despite the presence of a leak .
Laparoscopic or open reexploration is an appropriate diagnostic option, regardless of the feasibility of obtaining a postoperative imaging test, when a GI leak is suspected. Reexploration is characterized by a higher sensitivity, specificity, and accuracy than any other postoperative test to assess for leak and should be considered the definitive assessment for the possibility of a leak. Although invasive and not without potential difficulty or morbidity, several studies have reported that reexploration is a well-tolerated intervention compared with the consequences of peritonitis, excessive inflammatory response, sepsis, organ failure, and mortality, which may develop when diagnosis and treatment of a leak are delayed [2,46–49]. Thus, reexploration should be considered in patients with a suspected leak, and it is important to note that reliance on false-negative imaging studies may delay operative intervention, particularly when there is a leak at sites other than the gastrojejunostomy (e.g., the gastric remnant or the jejunojejunostomy) . Given the high mortality from untreated GI leaks, it is understood that reexploration, open or laparoscopic, is an appropriate and acceptable treatment modality when a GI leak is suspected.
Mainstays of laparoscopic or open reexploration follow the principles of drainage, creation of a controlled fistula with drains, antimicrobial therapy, and parenteral nutrition or enteral nutrition with consideration of feeding access of the jejunum either with a nasoenteric catheter placed beyond the area of leak or a gastrostomy tube placed in the gastric remnant. Limited data are available, in the form of case reports and small case series, on the use of biologic tissue sealants and the use of endoscopic stent placement for a gastrojejunal leak [50–52]. Further research may be helpful in refining the application of these technologies.
Nonoperative management of GI leaks after GB
It is understood that there is heterogeneity regarding the location, timing of presentation, magnitude or severity of leak, and/or degree of containment/contamination from a GI leak after GB, which can affect the clinical stability of a patient. GI leaks can occur long after a primary GB as a secondary consequence of other types of known complications such as internal hernia, trocar site hernia, adhesive bowel obstruction, perforated marginal ulcer, and so on. All of these factors can influence how a leak is clinically managed. Several small case series have emerged over the past 10 years that have reported the use of nonoperative management of a GI leak after GB [15,47,49,53–55].
Surgical management should always be considered in the early postoperative setting. However, nonoperative management of a GI leak after GB may be considered in selected and clinically stable patients. In general, the use of diagnostic imaging studies, including UGI and CT, can be considered more liberally in patients being considered for nonoperative management to better define the anatomic location, severity, and containment of a leak. Treatment options include bowel rest, antimicrobial agents, total parenteral nutrition, percutaneous drainage of collections, and percutaneous access into the remnant stomach both for decompression and feeding.
Response to treatment is measured clinically as well as by assessing drain outputs, resolution of leukocytosis, fever, and reimaging to confirm closure. Conversion of an acute leak into a controlled fistula that fails to close should raise suspicion to search for other factors that may promote nonhealing, such as downstream obstruction, stenosis, or foreign body (e.g., from introduction of a drain into the site of the leak). Clinicians, however, should maintain a low threshold for operative intervention in the face of clinical deterioration or failure of nonoperative management.
Prevention of GI leaks after SG
As with GI leaks after GB, GI leaks after SG are an important cause of morbidity and mortality. An overall decline in the incidence of leak after SG has been documented since the procedure’s inception. Part of this decline may be related to an emphasis on standardization of technique based on accrued experience as well as published recommendations from international consensus summits and expert panels [56,57]. The pathophysiology of a GI leak after SG may be different than that of GI leak after GB. Maintenance of the pylorus in the SG with surgical creation of a longer, narrower conduit results in higher intraluminal pressures compared with the gastric pouch created during GB. The latter is considered a lower pressure conduit, where gastric contents generally flow passively through the gastrojejunostomy into the small bowel. These differences may explain the more constant location of GI leaks and the delayed nature of presentation after SG compared with GB.
It is estimated that 75%–85% of leaks after SG will occur at the proximal third of the greater curvature staple line as opposed to the distal or antral staple line [12,58]. A few series have reported leaks exclusively at the proximal third of the greater curvature staple line [59–61]. Leaks have been reported to occur in the early postoperative period within a few days of surgery; however, most series have reported leaks occurring after > 5 days (5 to > 8) after surgery in 50%–80% of patients [62–65]. A recently published large systematic review looking at SG and the risk of a leak, which included 4888 patients, reported 79% of leaks were diagnosed after hospital discharge and 410 days after surgery . Technical factors that have been associated with an increased risk of a leak include bougie size < 40F; narrowing or stricture of the sleeve conduit, particularly at the level of the gastric incisura; and inadvertent stapling of the esophageal wall (rather than gastric tissue) at the gastroesophageal junction when creating the proximal staple line .
Stapling technology has evolved to include stapler heights able to accommodate different gastric wall tissue thicknesses, varying between individuals and in the different anatomic regions of the stomach. There is, however, no way to definitively identify the thickness of gastric tissue before stapling with the current technology. A variety of other options intended to help prevent GI leaks after SG have been described, including use of SLR (absorbable, remodelable, and permanent types), biological sealants, and oversewing (continuous, interrupted, full thickness, and Lembert techniques) of the staple line.
Three metaanalyses and several systematic reviews have been published within the past 5 years on the use of staple line reinforcement, with conclusions ranging from no significant effect on bleeding or leak, variable effect on leak depending on the material used for buttressing without assessment of bleeding, and no effect on leak but decreased staple line bleeding. One review identified buttressing to be associated with an increased risk of bleeding [67–76]. One randomized controlled trial on the use of fibrin sealant during SG reported a significant reduction in operative bleeding, although the clinical relevancy of this finding was not clear. Leak incidence, however, was not found to be significantly different . Most studies have not found oversewing to reduce the incidence of leak [67,78,79]. The heterogeneity of the studies, small statistical power, discrepancy of buttressing materials used, and variety of oversewing methods, in conjunction with varying staple heights and techniques (different bougie sizes) limit any recommendations regarding the use of these materials to prevent GI leak after SG. Several small case series have discussed the use of a routine intraoperative leak test (air, endoscopy, dye) to assess for intraoperative leak . As with GB, intraoperative leak tests can identify otherwise undetectable areas of staple line disruption but have not been reported to prevent subsequent leaks and should be used at the discretion of the surgeon.
Routine postoperative radiologic assessment for GI leaks after SG
Routine early postoperative UGI contrast studies are seldom advocated in most centers [25,58,60,65,81–83]. Early postoperative UGI contrast studies have very low sensitivity to detect a leak early after SG, because most leaks are reported to occur after hospital discharge and > 10 days after surgery . In addition, UGI contrast accuracy may vary depending on patient factors, such as body size and the ability to stand and swallow, among others, along with experience of the radiologist, the size of the leak, and the contrast material used . Based on current evidence, as with GB, the decision to perform routine versus selective UGI contrast studies should be left to the discretion of the surgeon, depending on factors related to the system of care in place and on other characteristics of the patient and population being treated.
Radiologic evaluation versus exploration for suspected GI leaks after SG
Tachycardia, fever, and abdominal pain (often radiating to the left shoulder or scapular region) are the most common, but not exclusive, signs of a GI leak after SG. In general, laboratory examinations are rarely contributory . In patients with clinical signs or symptoms of a suspected leak after SG, UGI contrast studies have a low sensitivity (0%–25%), though higher specificity (90%–95%). Because of its higher sensitivity, most studies recommend obtaining a CT with oral and IV contrast as the method of choice for diagnosis of a leak in patients who show signs and symptoms suggestive of a leak but remain clinically stable [31,55,61,62]. Inclusion of the chest may help rule out other causes of tachycardia such as pneumonia, pulmonary embolism, or pleural effusion. CT results are also influenced by patient factors, the experience of the radiologist, the size of the leak, and the contrast material used; however, high sensitivity (83%–93%) [58,60,65] and specificity (75%–100%) [65,83] are reported in most series. As with GI leak after GB, laparoscopic or open reexploration is an also appropriate diagnostic option, regardless of the feasibility of obtaining a postoperative imaging test, when a GI leak is suspected. Reexploration is characterized by a higher sensitivity, specificity, and accuracy than any other postoperative test to assess for leak and should be considered to be the definitive assessment for the possibility of leak when the patient is clinically unstable, or in the scenario wherein alternate diagnoses have been excluded and/or clinical suspicion remains [12,56,84].
Role of operative management of GI leaks after SG
The role of operative management in the setting of an SG leak differs significantly between an acute/early postoperative leak (<5 d) and chronic fistula (leaks present beyond 4 wk).
In an acute postoperative lead the primary goal of surgical management is to ensure prompt adequate drainage to avoid or manage abdominal sepsis and its consequences. Secondary goals include confirmation of diagnosis and insertion of feeling jejunostomy. The primary goal of early surgical management should not be definitive repair of the defect; however in the setting of very early reoperation (48-72 hr postoperative), primary suture and repair of the defect has been described as effective, but its efficacy decreases significantly thereafter. In the setting of a distal leak, primary repair including suturing or restapling might be more effective than in proximal leaks.
Given the higher pressures within the sleeve conduit, leaks may be difficult to seal despite adequate drainage. Over time, these may evolve into a chronic fistula. Non-operative management of these fistulas should be favored whenever possible. Average closure time of these fistulas may be > 4 weeks. Closure times of 3 months are not uncommon and durations of > 200 days have been reported [58,85,86].
Definitive surgical management in the presence of a chronic fistula is technically challenging. It should be reserved for nonhealing fistulas and only after sufficient time has lapsed to allow success of nonsurgical management. If the patient is adequately drained and is receiving appropriate nutrition, a minimum of 4 weeks  to 3 months should be allowed before nonoperative treatment is deemed unsuccessful .
Multiple surgical procedures have been described for management of nonhealing fistulas. They include laparoscopic or open gastrojejunal anastomosis [86–92], conversion to GB [88,93], total gastrectomy with esophagojejunostomy [58,88,93–95] and T-tube placement [96,97]. With a total of approximately 70 cases reported, no reliable conclusions can be drawn in terms of postoperative outcomes of these various treatment strategies. Reported operative times vary from 120–430 minutes with a median approximation of > 3 hours. Persistent and recurrent leaks up to > 50% have been described with the previously described techniques, although closure was eventually obtained nonoperatively [86–89,94,96].
Role of nonoperative management of GI leaks after SG
The mainstay of treatment of gastric leak after SG relies
on adequate drainage, nutritional support, and antibiotics
. Many surgeons advocate an initial nonoperative approach for treatment of GI leaks after sleeve gastrectomy in stable patients, whether presenting early or late after surgery [53,56,81,95,96]. Nonoperative treatment of leaks can require a multimodality, multidisciplinary approach to treatment, which may require input from gastroenterologists and radiologists in addition to the surgeon. The endoluminal, self-expandable stent may conform well to the tubularized stomach conduit after SG to effectively exclude the site of a proximal staple line leak. Stenting may allow patients to support their own nutritional needs with oral feeding during the healing process, potentially decreasing the overall duration of treatment . The majority of patients treated with an endoluminal stent achieve complete healing with a success rate of 55%–100% [58–60,63,83, 98–112]. Stenting often requires multiple endoscopies for stent replacement, or for the addition of other endoscopic adjuncts, over the course of treatment [59,101,106, 108,113]. Stent migration, kinking, erosion, and patient intolerance may complicate the use of endoluminal stents. Extralong, covered, self-expandable endoluminal stents have been developed, and their use may decrease the incidence of these stent-specific complications . It should be noted that the use of the current esophageal stent technology for the management of leaks is an off-label use of the device.
Wide clips placed with the use of an endoscope can
provide a mechanical approximation to close a GI fistula.
There is minimal risk of migration, and isolated case reports
have indicated short-term successful treatment of SG leak
when used alone, or in combination with other endoscopic
modalities [114,115]. An internal drain placed endoscopically through the staple line dehiscence may effectively control local sepsis by draining a perigastric abscess, promote resorption of fluid, enhance healing, and avoid the formation of an external fistula. Internal drainage strategies often require multiple endoscopies, drain replacements, and other adjuncts, however, to achieve complete healing [101,108]. Interest in biological glue has grown from case reports of successful treatment of gastrointestinal fistulae with fibrin glue injection. However, in the setting of a SG staple line leak, it is rarely successful as a stand-alone treatment and is more commonly used in combination with other endoscopic treatment modalities [58,106]. Endoscopic suturing devices are potential options in the armamentarium for nonoperative treatments of SG leaks; however, technologic shortcomings and lack of durability of primary suture closure are limiting, and this modality is not commonly used at this time .
Summary and recommendations
There has been a decrease in the incidence of GI leaks after primary stapled open and laparoscopic bariatric procedures (GB and SG) over time. Despite this decline, a GI leak remains a significant cause of morbidity and mortality and remains a potential complication of these procedures. Early detection and treatment remain pivotal principles in the management of GI leaks and may play a role in reducing subsequent morbidity and mortality. Some of the factors promoting leak may be different between GB and SG procedures. This may be related to the technical differences between the 2 procedures, as well as the distinct anatomic and physical properties that exist between the sleeve conduit versus the gastric pouch, which are helpful when considering some of the qualitative and temporal dissimilarities reported in the clinical manifestation of GI leaks after these procedures. Despite the advent of new technologies, the management of GI leaks after GB and SG procedures can be extremely complex and involve multiple and/or multimodal treatment options.
Intraoperative leak tests (air, dye, endoscopy) are described for both GB and SG. Although widely used, they have not been found to reduce the incidence of leak after GB and SG procedures.
Intraoperative leak prevention interventions described for both GB and SG procedures include oversewing, SLR, tissue sealants, and glue. There is still considerable debate over the utility or superiority of any of these interventions. Mandated use of any of these leak prevention interventions was not indicated by the data.
Radiographic studies after GB and SG procedures have varying sensitivity and specificity that is affected by study choice, patient factors, facility factors, and reviewer factors.
- There is no high-quality evidence available to mandate the routine postoperative use of UGI contrast studies after GB or SG procedures, particularly for SG given the greater likelihood of leaks presenting in a delayed fashion. Routine or selective UGI studies may, however, identify other technical or anatomic problems after GB or SG procedures. Based on current evidence, the decision to perform routine versus selective UGI contrast studies should be left to the discretion of the surgeon, based on factors related to the system of care in place and on other characteristics of the patient and the population being treated.
Radiographic evaluation versus surgical exploration for suspected leak after GB and SG.
- Clinically unstable patients suspected of having a leak may not be appropriate candidates for radiographic evaluation. Reexploration through a laparoscopic or open approach should be considered.
Operative management (open or laparoscopic) for acute GI leaks after GB or SG follows the goals of drainage, placement of drains to create controlled fistulas, use of antimicrobial agents, and nutrition considerations.
- Chronic fistulas are described after SG with long closure times (≥ 1–3 mo). Definitive surgical management of nonhealing fistulas is technically challenging, and current available data do not favor one procedure over another.
Nonoperative management may be an appropriate treatment option for GI leaks after GB or SG in stable patients.
- Nonoperative methods of GI leak treatment after both GB and SG include endoscopic endoluminal self-expandable stents, clips, endoscopic and percutaneously placed drains, and biologic glue/tissue sealants. Multiple endoscopies and multimodality treatments may be required to achieve full healing of a chronic fistula. The available data do not favor one treatment over another.
Gastrointestinal Leak Position Statement and Standard of Care
This Position Statement is not intended to provide inflexible rules or requirements of practice and is not intended, nor should it be used, to state or establish a local, regional, or national legal standard of care. Ultimately, there are various appropriate treatment modalities for each patient, and the surgeon must use their judgment in selecting from among the different feasible treatment options.
The American Society for Metabolic and Bariatric Surgery cautions against the use of this position statement in litigation in which the clinical decisions of a physician are called into question. The ultimate judgment regarding appropriateness of any specific procedure or course of action must be made by the physician in light of all the circumstances presented. Thus, an approach that differs from the position statement, standing alone, does not necessarily imply that the approach was below the standard of care. To the contrary, a conscientious physician may responsibly adopt a course of action different from that set forth in the position statement when, in the reasonable judgment of the physician, such course of action is indicated by the condition of the patient, limitations on available resources or advances in knowledge or technology. All that should be expected is that the physician will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient, in order to deliver effective and safe medical care. The sole purpose of this position statement is to assist practitioners in achieving this objective.
The authors have no commercial associations that might be a conflict of interest in relation to this article.
- Podnos YD, Jimenez JC, Wilson SE, et al. Complications after laparoscopic gastric bypass: a review of 3464 cases. Arch Surg 2003; 138(9):957‐61.
- Gonzalez R, Sarr MG, Smith CD, et al. Diagnosis and contemporary management of anastomotic leaks after gastric bypass for obesity. J Am Coll Surg 2007; 204(1):47‐55.
- Biertho L, Steffen R, Ricklin T, et al. Laparoscopic gastric bypass versus laparoscopic adjustable gastric banding: a comparative study of 1,200 cases. J Am Coll Surg 2003; 197(4):536‐44; discussion 544‐5.
- DeMaria EJ, Sugerman HJ, Kellum JM, et al. Results of 281 consecutive total laparoscopic Roux‐en‐Y gastric bypasses to treat morbid obesity. Ann Surg 2002; 235(5):640‐5; discussion 645‐7.
- Fernandez AZ, Jr., DeMaria EJ, Tichansky DS, et al. Experience with over 3,000 open and laparoscopic bariatric procedures: multivariate analysis of factors related to leak and resultant mortality. Surg Endosc 2004; 18(2):193‐7.
- Higa KD, Ho T, Boone KB. Laparoscopic Roux‐en‐Y gastric bypass: technique and 3‐year follow‐up. J Laparoendosc Adv Surg Tech A 2001; 11(6):377‐82.
- Nguyen NT, Goldman C, Rosenquist CJ, et al. Laparoscopic versus open gastric bypass: a randomized study of outcomes, quality of life, and costs. Ann Surg 2001; 234(3):279‐89; discussion 289‐91.
- Papasavas PK, Hayetian FD, Caushaj PF, et al. Outcome analysis of laparoscopic Roux‐en‐Y gastric bypass for morbid obesity. The first 116 cases. Surg Endosc 2002; 16(12):1653‐7.
- Schauer PR, Ikramuddin S, Gourash W, et al. Outcomes after laparoscopic Rouxen‐ Y gastric bypass for morbid obesity. 2000; 232(4):515‐29.
- Wittgrove AC, Clark GW. Laparoscopic gastric bypass, Roux‐en‐Y‐ 500 patients: technique and results, with 3‐60 month follow‐up. Obes Surg 2000; 10(3):233‐9.
- Al‐Sabah S, Ladouceur M, Christou N. Anastomotic leaks after bariatric surgery: it is the host response that matters. Surg Obes Relat Dis 2008; 4(2):152‐7; discussion 157‐8.
- Miller KA, Pump A. Use of bioabsorbable staple reinforcement material in gastric bypass: a prospective randomized clinical trial. Surg Obes Relat Dis 2007; 3(4):417‐21; discussion 422.
- Shikora SA. The use of staple‐line reinforcement during laparoscopic gastric bypass. Obes Surg 2004; 14(10):1313‐20.
- Sapala JA, Wood MH, Schuhknecht MP. Anastomotic leak prophylaxis using a vapor‐heated fibrin sealant: report on 738 gastric bypass patients. Obes Surg 2004; 14(1):35‐42.
- Livingston EH, Liu CY, Glantz G, Li Z. Characteristics of bariatric surgery in an integrated VA Health Care System: follow‐up and outcomes. J Surg Res 2003; 109(2):138‐43.
- Silecchia G, Boru C, Pecchia A, et al. Effectiveness of laparoscopic sleeve gastrectomy (first stage of biliopancreatic diversion with duodenal switch) on comorbidities in super‐obese high‐risk patients. Obes Surg 2006; 16(9):1138‐44.
- Chousleb E, Szomstein S, Podkameni D, et al. Routine abdominal drains after laparoscopic Roux‐en‐Y gastric bypass: a retrospective review of 593 patients. Obes Surg 2004; 14(9):1203‐7.
- Csendes A, Burdiles P, Burgos AM, et al. Conservative management of anastomotic leaks after 557 open gastric bypasses. Obes Surg 2005; 15(9):1252‐ 6.
- Dallal RM, Bailey L, Nahmias N. Back to basics‐‐clinical diagnosis in bariatric surgery. Routine drains and upper GI series are unnecessary. Surg Endosc 2007; 21(12):2268‐71.
- Garcia‐Caballero M, Carbajo M, Martinez‐Moreno JM, et al. Drain erosion and gastro‐jejunal fistula after one‐anastomosis gastric bypass: endoscopic occlusion by fibrin sealant. Obes Surg 2005; 15(5):719‐22.
- Inge TH, Donnelly LF, Vierra M, et al. Managing bariatric patients in a children’s hospital: radiologic considerations and limitations. J Pediatr Surg 2005; 40(4):609‐17.
- Dresel A, Kuhn JA, McCarty TM. Laparoscopic Roux‐en‐Y gastric bypass in morbidly obese and super morbidly obese patients. Am J Surg 2004; 187(2):230‐ 2; discussion 232.
- Gould JC, Garren MJ, Boll V, Starling JR. Laparoscopic gastric bypass: risks vs. benefits up to two years following surgery in super‐super obese patients. Surgery 2006; 140(4):524‐9; discussion 529‐31.
- Taylor JD, Leitman IM, Hon P, et al. Outcome and complications of gastric bypass in super‐super obesity versus morbid obesity. Obes Surg 2006; 16(1):16‐8.
- Tichansky DS, DeMaria EJ, Fernandez AZ, et al. Postoperative complications are not increased in super‐super obese patients who undergo laparoscopic Roux‐en‐Y gastric bypass. Surg Endosc 2005; 19(7):939‐41.
- Shuhaiber J, Vitello J. Is gastric bypass associated with more complications in patients weighing >500 lb (>227 kg)? Obes Surg 2004; 14(1):43‐6.
- Kolakowski S, Jr., Kirkland ML, Schuricht AL. Routine postoperative upper gastrointestinal series after Roux‐en‐Y gastric bypass: determination of whether it is necessary. Arch Surg 2007; 142(10):930‐4; discussion 934.
- Lee SD, Khouzam MN, Kellum JM, et al. Selective, versus routine, upper gastrointestinal series leads to equal morbidity and reduced hospital stay in laparoscopic gastric bypass patients. Surg Obes Relat Dis 2007; 3(4):413‐6.
- Doraiswamy A, Rasmussen JJ, Pierce J, et al. The utility of routine postoperative upper GI series following laparoscopic gastric bypass. Surg Endosc 2007; 21(12):2159‐62.
- Madan AK, Stoecklein HH, Ternovits CA, et al. Predictive value of upper gastrointestinal studies versus clinical signs for gastrointestinal leaks after laparoscopic gastric bypass. Surg Endosc 2007; 21(2):194‐6.
- Weiss CR, Scatarige JC, Diette GB, et al. CT pulmonary angiography is the firstline imaging test for acute pulmonary embolism: a survey of US clinicians. Acad Radiol 2006; 13(4):434‐46.
- Patel S, Kazerooni EA. Helical CT for the evaluation of acute pulmonary embolism. AJR Am J Roentgenol 2005; 185(1):135‐49.
- Merkle EM, Hallowell PT, Crouse C, et al. Roux‐en‐Y gastric bypass for clinically severe obesity: normal appearance and spectrum of complications at imaging. Radiology 2005; 234(3):674‐83.
- Marshall JS, Srivastava A, Gupta SK, et al. Roux‐en‐Y gastric bypass leak complications. Arch Surg 2003; 138(5):520‐3; discussion 523‐4.
- Durak E, Inabnet WB, Schrope B, et al. Incidence and management of enteric leaks after gastric bypass for morbid obesity during a 10‐year period. Surg Obes Relat Dis 2008.
- Lee S, Carmody B, Wolfe L, et al. Effect of location and speed of diagnosis on anastomotic leak outcomes in 3828 gastric bypass cases. J Gastrointest Surg 2007; 11(6):708‐13.
- Iqbal A, Miedema B, Ramaswamy A, et al. Long-term outcome after endoscopic stent therapy for complications after bariatric surgery. Surg Endosc 2011;25(2):515–20.
- Liu CD, Glantz GJ, Livingston EH. Fibrin glue as a sealant for high-risk anastomosis in surgery for morbid obesity. Obes Surg 2003;13 (1):45–8.
- Victorzon M, Victorzon S, Peromaa-Haavisto P. Fibrin glue and stents in the treatment of gastrojejunal leaks after laparoscopic gastric bypass: a case series and review of the literature. Obes Surg 2013;23(10):1692–7.
- Ballesta C, Berindoague R, Cabrera M, Palau M, Gonzales M. Management of anastomotic leaks after laparoscopic Roux-en-Y gastric bypass. Obes Surg 2008;18(6):623–30.
- Bège T, Emungania O, Vitton V, et al. An endoscopic strategy for management of anastomotic complications from bariatric surgery: a prospective study. Gastrointest Endosc 2011;73(2):238–44.
- Csendes A, Burdiles P, Burgos AM, Maluenda F, Diaz JC. Conservative management of anastomotic leaks after 557 open gastric bypasses. Obes Surg 2005;15(9):1252–6.
- Deitel M, Gagner M, Erickson AL, Crosby RD. Third International Summit: current status of sleeve gastrectomy. Surg Obes Relat Dis 2011;7(6):749–59.
- Rosenthal RJ, International Sleeve Gastrectomy Expert Panel, Diaz AA, et al. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of 412,000 cases. Surg Obes Relat Dis 2012;8(1):8–19.
- Sakran N, Goitein D, Raziel A, et al. Gastric leaks after sleeve gastrectomy: a multicenter experience with 2,834 patients. Surg Endosc 2013;27(1):240–5.
- Simon F, Siciliano I, Gillet A, Castel B, Coffin B, Msika S. Gastric leak after laparoscopic sleeve gastrectomy: early covered self-expandable stent reduces healing time. Obes Surg 2013;23(5): 687–692.
- Spyropoulos C, Argentou M-I, Petsas T, Thomopoulos K, Kehagias I, Kalfarentzos F. Management of gastrointestinal leaks after surgery for clinically severe obesity. Surg Obes Relat Dis 2012;8(5):609–15.
- Burgos AM, Braghetto I, Csendes A, et al. Gastric leak after laparoscopic-sleeve gastrectomy for obesity. Obes Surg 2009;19 (12):1672–7.
- Gnecchi M, Bella G, Pino AR, et al. Usefulness of x-ray in the detection of complications and side effects after laparoscopic sleeve gastrectomy. Obes Surg 2013;23(4):456–9.
- Jurowich C, Thalheimer A, Seyfried F, et al. Gastric leakage after sleeve gastrectomy-clinical presentation and therapeutic options. Langenbecks Arch Surg 2011;396(7):981–7.
- Wahby M, Salama AF, Elezaby AF, et al. Is routine postoperative gastrografin study needed after laparoscopic sleeve gastrectomy? Experience of 712 cases. Obes Surg 2013;23(11):1711–7.
- Mizrahi I, Tabak A, Grinbaum R, et al. The utility of routine postoperative upper gastrointestinal swallow studies following laparoscopic sleeve gastrectomy. Obes Surg 2014;24(9):1415–9.
- Benedix F, Benedix DD, Knoll C, et al. Are there risk factors that increase the rate of staple line leakage in patients undergoing primary sleeve gastrectomy for morbid obesity? Obes Surg 2014;24 (10):1610–6.
- Al Hajj GN, Haddad J. Preventing staple-line leak in sleeve gastrectomy: reinforcement with bovine pericardium vs. oversewing. Obes Surg 2013;23(11):1915–21.
- Angrisani L, Cutolo PP, Buchwald JN, et al. Laparoscopic reinforced sleeve gastrectomy: early results and complications. Obes Surg 2011;21(6):783–93.
- Chen B, Kiriakopoulos A, Tsakayannis D, Wachtel MS, Linos D, Frezza EE. Reinforcement does not necessarily reduce the rate of staple line leaks after sleeve gastrectomy. A review of the literature and clinical experiences. Obes Surg 2009;19(2):166–72.
- Choi YY, Bae J, Hur KY, Choi D, Kim YJ. Reinforcing the staple line during laparoscopic sleeve gastrectomy: does it have advantages? A meta-analysis. Obes Surg 2012;22(8):1206–13.
- Dapri G, Cadière GB, Himpens J. Reinforcing the staple line during laparoscopic sleeve gastrectomy: prospective randomized clinical study comparing three different techniques. Obes Surg 2010;20(4): 462–467.
- Gentileschi P, Camperchioli I, D’Ugo S, Benavoli D, Gaspari AL. Staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial. Surg Endosc 2012;26(9):2623–9.
- Giannopoulos GA, Tzanakis NE, Rallis GE, Efstathiou SP, Tsigris C, Nikiteas NI. Staple line reinforcement in laparoscopic bariatric surgery: does it actually make a difference? A systematic review and meta-analysis. Surg Endosc 2010;24(11):2782–8.
- Glaysher M, Khan OA, Mabvuure NT, Wan A, Reddy M, Vasilikostas G. Staple line reinforcement during laparoscopic sleeve gastrectomy: does it affect clinical outcomes? Int J Surg Lond Engl 2013;11(4):286–9.
- Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann Surg 2013;257(2):231–7.
- Simon TE, Scott JA, Brockmeyer JR, et al. Comparison of stapleline leakage and hemorrhage in patients undergoing laparoscopic sleeve gastrectomy with or without Seamguard. Am Surg 2011;77 (12):1665–8.
- Musella M, Milone M, Maietta P, Bianco P, Pisapia A, Gaudioso D. Laparoscopic sleeve gastrectomy: efficacy of fibrin sealant in reducing postoperative bleeding. A randomized controlled trial. Updat Surg 2014;66(3):197–201.
- Aggarwal S, Sharma AP, Ramaswamy N. Outcome of laparoscopic sleeve gastrectomy with and without staple line oversewing in morbidly obese patients: a randomized study. J Laparoendosc Adv Surg Tech A 2013;23(11):895–9.
- Musella M, Milone M, Bellini M, Leongito M, Guarino R, Milone F. Laparoscopic sleeve gastrectomy. Do we need to oversew the staple line? Ann Ital Chir 2011;82(4):273–7.
- Aggarwal S, Bhattacharjee H, Chander Misra M. Practice of routine intraoperative leak test during laparoscopic sleeve gastrectomy should not be discarded. Surg Obes Relat Dis 2011;7(5):e24–5.
- Brockmeyer JR, Simon TE, Jacob RK, Husain F, Choi Y. Upper gastrointestinal swallow study following bariatric surgery: institutional review and review of the literature. Obes Surg 2012;22(7): 1039–1043.
- Goitein D, Goitein O, Feigin A, Zippel D, Papa M. Sleeve gastrectomy: radiologic patterns after surgery. Surg Endosc 2009;23(7): 1559–1563.
- Tan JT, Kariyawasam S, Wijeratne T, Chandraratna HS. Diagnosis and management of gastric leaks after laparoscopic sleeve gastrectomy for morbid obesity. Obes Surg 2010;20(4):403–9.
- Gagner M, Deitel M, Kalberer TL, Erickson AL, Crosby RD. The Second International Consensus Summit for Sleeve Gastrectomy, March 19-21, 2009. Surg Obes Relat Dis 2009;5(4):476–85.
- De Aretxabala X, Leon J, Wiedmaier G, et al. Gastric leak after sleeve gastrectomy: analysis of its management. Obes Surg 2011;21 (8):1232–7.
- Chour M, Alami RS, Sleilaty F, Wakim R. The early use of Roux limb as surgical treatment for proximal postsleeve gastrectomy leaks. Surg Obes Relat Dis 2014;10(1):106–10.
- Chouillard E, Chahine E, Schoucair N, et al. Roux-En-Y fistulojejunostomy as a salvage procedure in patients with post-sleeve gastrectomy fistula. Surg Endosc 2014;28(6):1954–60.
- Nedelcu AM, Skalli M, Deneve E, Fabre JM, Nocca D. Surgical management of chronic fistula after sleeve gastrectomy. Surg ObesRelat Dis 2013;9(6):879–84.
- Iannelli A, Tavana R, Martini F, Noel P, Gugenheim J. Laparoscopic roux limb placement over a fistula defect without mucosa-to-mucosa anastomosis: a modified technique for surgical management of chronic proximal fistulas after laparoscopic sleeve gastrectomy. Obes Surg 2014;24(5):825–8.
- Vilallonga R, Himpens J, van de Vrande S. Laparoscopic Roux limb placement for the management of chronic proximal fistulas after sleeve gastrectomy: technical aspects. Surg Endosc 2015;29(2): 414–416.
- Van de Vrande S, Himpens J, El Mourad H, Debaerdemaeker R, Leman G. Management of chronic proximal fistulas after sleeve gastrectomy by laparoscopic Roux-limb placement. Surg Obes Relat Dis 2013;9(6):856–61.
- Baltasar A, Bou R, Bengochea M, Serra C, Cipagauta L. Use of a Roux limb to correct esophagogastric junction fistulas after sleeve gastrectomy. Obes Surg 2007;17(10):1408–10.
- Moszkowicz D, Arienzo R, Khettab I, et al. Sleeve gastrectomy severe complications: is it always a reasonable surgical option? Obes Surg 2013;23(10):676–86.
- Ben Yaacov A, Sadot E, Ben David M, Wasserberg N, Keidar A. Laparoscopic total gastrectomy with Roux-y esophagojejunostomy for chronic gastric fistula after laparoscopic sleeve gastrectomy. Obes Surg 2014;24(9):425–9.
- Thompson CE, Ahmad H, Lo Menzo E, Szomstein S, Rosenthal RJ. Outcomes of laparoscopic proximal gastrectomy with esophagojejunal reconstruction for chronic staple line disruption after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis 2014;10(3):455–9.
- El Hassan E, Mohamed A, Ibrahim M, Margarita M, Al Hadad M, Nimeri AA. Single-stage operative management of laparoscopic sleeve gastrectomy leaks without endoscopic stent placement. Obes Surg 2013;23(5):722–6.
- Court I, Wilson A, Benotti P, Szomstein S, Rosenthal RJ. T-tube gastrostomy as a novel approach for distal staple line disruption after sleeve gastrectomy for morbid obesity: case report and review of the literature. Obes Surg 2010;20(4):519–22.
- Alazmi W, Al-Sabah S, Ali DA, Almazeedi S. Treating sleeve gastrectomy leak with endoscopic stenting: the Kuwaiti experience and review of recent literature. Surg Endosc 2014;28(12):3425–8.
- Fukumoto R, Orlina J, McGinty J, Teixeira J. Use of Polyflex stents in treatment of acute esophageal and gastric leaks after bariatric surgery. Surg Obes Relat Dis 2007;3(1):68–71; discussion 71–2.
- Nguyen NT, Nguyen X-MT, Dholakia C. The use of endoscopic stent in management of leaks after sleeve gastrectomy. Obes Surg 2010;20(9):1289–92.
- Pequignot A, Fuks D, Verhaeghe P, et al. Is there a place for pigtail drains in the management of gastric leaks after laparoscopic sleeve gastrectomy? Obes Surg 2012;22(5):712–20.
- El Mourad H, Himpens J, Verhofstadt J. Stent treatment for fistula after obesity surgery: results in 47 consecutive patients. Surg Endosc 2013;27(3):808–16.
- Serra C, Baltasar A, Andreo L, et al. Treatment of gastric leaks with coated self-expanding stents after sleeve gastrectomy. Obes Surg 2007;17(7):866–72.
- Eisendrath P, Cremer M, Himpens J, Cadière G-B, Le Moine O, Devière J. Endotherapy including temporary stenting of fistulas of the upper gastrointestinal tract after laparoscopic bariatric surgery. Endoscopy 2007;39(7):625–30.
- Oshiro T, Kasama K, Umezawa A, Kanehira E, Kurokawa Y. Successful management of refractory staple line leakage at the esophagogastric junction after a sleeve gastrectomy using the HANAROSTENT. Obes Surg 2010;20(4):530–4.
- Casella G, Soricelli E, Rizzello M, et al. Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg 2009;19(7):821–6.
- Blackmon SH, Santora R, Schwarz P, Barroso A, Dunkin BJ. Utility of removable esophageal covered self-expanding metal stents for leak and fistula management. Ann Thorac Surg 2010;89(3): 931–936; discussion 936–7.
- Donatelli G, Ferretti S, Vergeau BM, et al. Endoscopic internal drainage with enteral nutrition (EDEN) for treatment of leaks following sleeve gastrectomy. Obes Surg 2014;24(8):1400–7.
- Slim R, Smayra T, Chakhtoura G, Noun R. Endoscopic stenting of gastric staple line leak following sleeve gastrectomy. Obes Surg 2013;23(11):1942–5.
- Corona M, Zini C, Allegritti M, et al. Minimally invasive treatment of gastric leak after sleeve gastrectomy. Radiol Med (Torino) 2013; 118(6):962–70.
- Galloro G, Magno L, Musella M, Manta R, Zullo A, Forestieri P. A novel dedicated endoscopic stent for staple-line leaks after laparoscopic sleeve gastrectomy: a case series. Surg Obes Relat Dis 2014; 10(4):607–11.
- Vix M, Diana M, Marx L, et al. Management of staple line leaks after sleeve gastrectomy in a consecutive series of 378 patients. Surg Laparosc Endosc Percutan Tech 2015;25(1):89–93.
- Eubanks S, Edwards CA, Fearing NM, et al. Use of endoscopic stents to treat anastomotic complications after bariatric surgery. J Am Coll Surg 2008;206(5):935–8; discussion 938–9.
- Aly A, Lim HK. The use of over the scope clip (OTSC) device for sleeve gastrectomy leak. J Gastrointest Surg 2013;17(3):606–8.
- Conio M, Blanchi S, Repici A, Bastardini R, Marinari GM. Use of an over-the-scope clip for endoscopic sealing of a gastric fistula after sleeve gastrectomy. Endoscopy 2010;42(Suppl 2):E71–2.
- Schweitzer M, Steele K, Mitchell M, Okolo P. Transoral endoscopic closure of gastric fistula. Surg Obes Relat Dis 2009;5(2):283–4.