ORIGINAL ARTICLE

Management of Staple Line Leaks After Sleeve Gastrectomy in a Consecutive Series of 378 Patients Michel Vix, MD,* Michele Diana, MD,* Ludovic Marx, MD,* Cosimo Callari, MD,w Hurng-Sheng Wu, MD,z Silvana Perretta, MD,* Didier Mutter, MD, PhD, FACS,* and Jacques Marescaux, MD, (Hon) FRCS, (Hon) FACS, (Hon) FJSES*

Introduction: Laparoscopic sleeve gastrectomy (LSG) is gaining acceptance as a stand-alone bariatric procedure with proven efficacy on weight loss and obesity-related comorbidities. A specific and potentially severe complication of LSG is the staple line leak (SLL). Our aim was to report the SLL rate and its management in a prospective cohort of 378 LSGs. Patients and Methods: A total of 378 patients underwent LSG from July 2005 to July 2011. The gastric transection was performed by an initial 60 mm firing of 4.5 mm staples at the antrum and successive 60 mm firings of 3.5 mm staples at the gastric body and fundus toward the left diaphragmatic crus. A 36 Fr bougie was used to calibrate the gastric tube. The staple line was systematically reinforced with a partial-thickness running suture. Results: The overall complications and SLL rate were 20/378 (5.29%) and 9/378 (2.38%), respectively. SLLs were managed by laparoscopic (n = 2) or open (n = 1) exploration, drainage and endoscopic self-expandable covered stent, computed tomography– guided percutaneous drainage (n = 2), or a self-expandable covered stent alone (n = 4). Medical support including total parenteral nutrition and adapted antibiotics was started in all patients. The combined treatment modalities were successful in all cases. Conclusions: SLL was the most common complication of LSG accounting for half of the overall complications. Percutaneous drainage and self-covered stents combined with antibiotics and parenteral nutrition are effective for SLL and should be proposed as first-line treatment in stable patients. Key Words: laparoscopic sleeve gastrectomy, complications, staple line leak, staple line reinforcement, self-expanded covered stent, nonsurgical management

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aparoscopic sleeve gastrectomy (LSG) was initially proposed as a first-stage procedure before a more

Received for publication September 12, 2013; accepted September 30, 2013. From the *Department of General, Digestive and Endocrine Surgery, IRCAD-IHU, University of Strasbourg, Strasbourg, France; wDepartment of General Surgery, UCSC, Catholic University of Sacred Heart, Policlinico Gemelli, Rome, Italy; and zIRCAD-AITS, Show Chow Health Care System, Changhua, Taiwan. Part of this work was presented at the SAGES annual meeting, March 8, 2012, San Diego, CA (abstract no. 38197). M.D. is a recipient of a research grant from KarlStorz Endoskope (Tuˆttlingen, Germany). J.M. is a recipient of grants from KarlStorz, Covidien and Siemens Healthcare. The remaining authors declare no conflicts of interest. Reprints: Jacques Marescaux, MD, FACS, (Hon) FRCS, (Hon) FJSES, Department of General, Digestive and Endocrine Surgery, University Hospital of Strasbourg, France, 1 place de l’Hoˆpital, 67091 Strasbourg, France (e-mail: [email protected]). Copyright r 2014 Wolters Kluwer Health, Inc. All rights reserved.

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complex bariatric operation, the bilio-pancreatic diversion with duodenal switch, especially in high-risk patients.1 Currently, with 10 years of feedback, LSG is gaining wide acceptance as a stand-alone bariatric procedure. LSG is as effective as the Roux-en-Y gastric bypass (RYGBP) in the improvement of obesity-related comorbidities and is associated with fewer postoperative metabolic deficiencies.2–4 In addition, from a purely technical standpoint, LSG is considered a less challenging procedure when compared with the RYGBP with a shorter learning curve.5,6 Specific and potentially severe complications of LSG, although rare, are bleeding from the staple line and staple line leakage (SLL). SLLs are more frequently (80%) “high leaks” or proximal leaks (occurring at the level of the cardia, below the gastro-esophageal junction), with an incidence of approximately 1.3% (range, 0% to 10%), whereas “lower leaks” or distal leaks occur in 0.5% of cases.7 This difference in the incidence is partly explained by the better vascular supply of the stomach body compared with the cardia. An SLL may result in severe morbidity with potential sepsis and life-threatening organ failure.8,9 Although in laparoscopic RYGBP there is a similar stapled resection when creating the gastric pouch with a long staple line, SLL seems to be less likely to occur. One of the surmises that has been formulated as a potential underlying mechanism of the SLL in the LSG is increased intraluminal pressure10 secondary to tubular gastric volume reduction, which may further impair the vascular supply. SLLs have been defined as9 acute, early, late, and chronic. In “acute leaks” (occurring within the first 48 h), a reduced mechanical strength is more likely due to technical errors and staple line crossing, whereas a vascular supply deficiency and gastric inflammation account primarily for “early leaks” (within the first week). Staple line reinforcement with oversewing or buttressing material has been described as a potential prophylactic measure in reducing bleeding, but its interest in preventing SLL is not demonstrated.11 At the third International Summit for Sleeve Gastrectomy, which was held recently,7 the attending experts were asked to answer a questionnaire and describe their strategies regarding staple line enhancement: two thirds of surgeons stated that they would reinforce the staple line (57% with buttress material, and 43% with oversewing). SLL management depends on the presence and size of intra-abdominal collections, on the extent of the leak, and on the patient’s hemodynamic status. Nonsurgical approaches (endoscopic covered stent placement, biological glue injection, defect clipping, and/or image-guided drainage in various combinations) may be safe and effective when appropriate. Alimentary exclusion, antibiotics, and

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parenteral nutrition may be the ancillary therapies.9,12 The general consensus has it that the use of a stent for acute proximal leaks is a valid treatment option, whereas chronic leak stenting is of limited utility. Surgery aims to cleanse and drain intra-abdominal collections and may be immediately required in case of uncontained symptomatic leaks [even with normal upper gastrointestinal series (UGS)]. Surgeons should wait for at least 12 weeks of conservative therapy before reintervention to convert or revise proximal leaks (if the patient is stable). In case of chronic leaks, a possible treatment option, to be considered when the other modalities fail, is to place a Roux-en-Y bowel loop over the leak (realizing a 1-loop minigastric bypass) or to proceed to a conversion to an RYGBP. Suturing of the leaking site is not recommended according to the most recent guidelines,9 as it appears ineffective. The aim of this study was to report the rate and the management of SLL in a prospective cohort of LSG performed at a teaching hospital.

PATIENTS AND METHODS From July 2005 to July 2011, 378 consecutive patients underwent LSG performed by chief residents (n = 287) and a senior consultant in bariatric surgery (n = 91) at the Department of General, Digestive, and Endocrine Surgery, University of Strasbourg, France. All chief residents had completed their full training in general surgery, all of them being at least in postgraduate year 9 (PGY9). Patients’ demographics are presented in Table 1.

Surgical Procedure The standard access to the peritoneal cavity was performed through a 5-port configuration (Fig. 1). The surgical technique included the mobilization of the greater curvature of the stomach using the Ligasure device (Covidien, Boulder, CO) and the gastric transection starting approximately 5 cm from the pylorus using successive firings of 4.5 mm high staples (Endo-GIA 60 mm; Covidien) at the antrum and 3.5 or 4.5 mm high staples at the gastric body and fundus toward the left diaphragmatic crus, depending on gastric thickness. A 36 Fr bougie was used to calibrate the gastric tube. The staple line was systematically reinforced with a running suture (Fig. 2).

FIGURE 1. Standard port placement. The standard access to the peritoneal cavity was performed through a 5-port configuration (n = 362). A, 10 mm port for the optic; (B and C) 10 mm port for surgeon working instruments; (D) 5 mm port for liver retractor; (E) 5 mm port for assistant grasping instrument. When performing the stapling, the skin incision in (A) may be upsized to insert a 15 mm port to allow the use of the linear stapler loaded with 4.5 mm height staples, (Green Cartridge, 60 mm; Covidien).

pump inhibitors, and thromboprophylaxis. UGS with oral contrast (Gastrografin) were performed on the first postoperative day (POD1). Patients were on a liquid diet from POD1 to POD15. In case of an uneventful postoperative course, patients were discharged on POD3.

Stenting In case of diagnosis of SLL, a self-expandable covered endoscopic stent (SECS) (Hanarostent, ECBB; M.I. Tech., Seoul, South Korea) was inserted endoscopically under fluoroscopic guidance to cover the fistula, with the patient

Postoperative Care All patients received a standardized postoperative care protocol including a patient-controlled analgesia delivering morphine and droperidol for the first 24 hours, proton-

TABLE 1. Demographics

All (n = 378) Age [mean (SD)] (y) Sex (M/F) BMI [mean (SD)] (kg/m2) Charlson Comorbidity Score [mean (SD)] Redo after gastric banding Senior surgeon/chief residents

Leak (n = 9)

P

39.83 (11.19) 36.88 (9.31) 0.43 61/317 2/7 0.36 45.95 (6.87) 43.63 (5.04) 0.31 1.84 (1.21) 1.37 (1.08) 0.12 37 91/287

BMI indicates body mass index.

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2 3/6

0.21 0.25 FIGURE 2. Final aspect of the sleeve gastrectomy. The staple line was systematically reinforced with a running suture.

Copyright

r

2014 Wolters Kluwer Health, Inc. All rights reserved.

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under general anesthesia. The ends of the Hanarostent are larger than the central shaft, and this particular shape allows to fix the stent within the esophagus, and consequently risk for migration could well be reduced. An endoscopic control was performed 4 weeks after Hanarostent placement. The stent was then removed and, if needed, replaced with a new one. The treatment was continued until healing of the fistula.

Follow-up Patients were followed up at 1 week, 3 months, 6 months, 1 year, and later on once per year.

Statistical Analysis Statistics were obtained using WinSTAT for Excel, Robert K Fitch Software. The Fisher exact test was used to calculate P values for categorical data. The t test was used to calculate P values for continuous variables. A P value

Management of staple line leaks after sleeve gastrectomy in a consecutive series of 378 patients.

Laparoscopic sleeve gastrectomy (LSG) is gaining acceptance as a stand-alone bariatric procedure with proven efficacy on weight loss and obesity-relat...
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