Outcome of Laparoscopic Sleeve Gastrectomy With and Without Staple Line Oversewing in Morbidly Obese Patients: A Randomized Study

Abstract

Introduction:

Laparoscopic sleeve gastrectomy (LSG) is a popular bariatric procedure with a low complication rate. Serious complications after LSG include gastric leak and staple line bleeding. In order to reduce these complications, staple line reinforcement has been practiced variably by many surgeons. There is no conclusive evidence to suggest that routine oversewing of the staple line or reinforcement with buttressing material after LSG decreases these complications. We therefore undertook a prospective randomized controlled trial to evaluate the impact of oversewing of the staple line in preventing complications after LSG.

Patients and Methods:

Sixty patients undergoing LSG were randomly allocated to two groups. In Group A, the entire staple line was reinforced with continuous suturing, and in Group B, no reinforcement was used. Thirty patients were enrolled in each group. Indications for this procedure were morbidly obese (body mass index ≥40 kg/m²) or severely obese (body mass index ≥35 kg/m²) patients with comorbidities including type 2 diabetes mellitus, hypertension, sleep apnea, and osteoarthritis. Complications including gastric leak, bleeding, and stricture were recorded.

Results:

The demographic parameters were comparable in the two groups. Two cases of early gastric leak occurred in Group B and none in Group A. There was no case of staple line bleeding or stricture in either group, although 1 patient in Group B had bleeding from the omentum that required re-operation. The overall surgical complication rate was 5%. The mean operative time in Group A (139±10 minutes) was significantly greater than in Group B (117±19 minutes) (P=.02).

Conclusions:

Oversewing of the staple line may lead to reduction in leak rate, although a larger study is required to reach a definitive conclusion. The incidence of staple line bleeding can be minimized by following meticulous technique and adequate compression time after closure of the stapler rather than placing undue emphasis on oversewing and expensive buttressing materials.

Introduction

Laparoscopic sleeve gastrectomy (LSG), initially introduced as a part of a duodenal switch operation,¹ has become a popular stand-alone procedure for weight loss surgery.^2,3 At our center, LSG has been used as the principal bariatric procedure in most patients with excellent short-term results in terms of weight loss and resolution of comorbidities.

One of the key unresolved technical issues is the staple line reinforcement (SLR) during LSG.⁴ The staple line can be reinforced either by oversewing of the staple line or by use of buttressing material. The purported advantages of SLR are a decrease in bleeding from the staple line and a decrease in the rate of leaks. However, it is unclear whether SLR leads to a decrease in staple line leaks. Another fringe benefit could be further narrowing of the sleeve size, which could result in better weight loss. However, oversewing of the staple line could result in an increased rate of stricture. It also adds to the operative time as well as to the cost. Paradoxically, it can also lead to an increased rate of staple line leaks by causing distal narrowing and resultant increase in intragastric pressure.

In view of some recent reports^5,6 suggesting that oversewing of the staple line may not be necessary, we conducted a study to compare the outcome in two groups of patients undergoing LSG with and without oversewing of the staple line.

Patients and Methods

After clearance from the Institutional Ethics Committee, a prospective randomized controlled study was conducted at our institution, a tertiary-level teaching hospital. Sixty consecutive patients who underwent LSG for morbid obesity from June 2009 and June 2011 were included in the study. They were subsequently followed up for 1 year under the supervision of a dedicated bariatric team. These patients were randomized into the following two groups using computer-generated random numbers, which were then sealed in envelopes and opened by the floor nurse before the start of each case: Group A (control group), patients underwent LSG with oversewing of the entire staple line with a continuous suture; or Group B (test group), patients underwent LSG without oversewing of the staple line.

We followed the standard National Institute of Health guidelines for selection of patients, which included patients with morbid obesity defined as a body mass index (BMI) of >40 kg/m² or patients with a BMI of >35 kg/m² with obesity-related comorbidities. A detailed preoperative evaluation was done. All patients were advised to consume a very low calorie diet for at least 2 weeks before surgery.

Operative technique

The sleeve is created in a standard fashion. Four ports—three 12-mm and one 5-mm—are used. The liver is retracted using a self-retaining liver retractor through a 5-mm incision in the epigastrium. Using ultrasonic shears, the greater curvature is completely freed up to the medial border of the left crus of the diaphragm to completely resect the gastric fundus. A 36 French bougie (gastric calibration tube) is then inserted and aligned along the lesser curvature to obtain a precise calibration and to avoid stenosis of the gastroplasty. The resection starts at 5 cm from the pylorus using a 60-mm laparoscopic linear stapler-cutter (Echelon Endopath™; Ethicon Endo-Surgery, Cincinnati, OH). The resection continues in the direction of the angle of His with sequential firings of the laparoscopic linear cutter. In Group A (control group), the whole staple line is oversewn by a continuous seromuscular suture using 2-0 polydiaxonone, starting from the angle of His. In Group B, the staple line is not oversewn or buttressed.

In both groups, an intraoperative leak test is done by insufflating air through a nasogastric tube after the pylorus is occluded with a soft clamp. A drain is placed in the perigastric region. The gastrectomy specimen is removed in a bag by enlarging one of the 12-mm port sites in the left upper abdomen. This port site is closed under vision using a port closure device.

Postoperative management

In the immediate postoperative period, patients are monitored in the high dependency unit. An oral diatrizoate meglumine and diatrizoate sodium (Gastrografin^®; Bracco Diagnostics Inc., Princeton, NJ) study is performed on postoperative Day 1 to look for any leak and/or hold up of contrast. If the study is normal, the patient is started on oral liquids. Gradual ambulation is commenced on the day of surgery. The patients are monitored for postoperative complications, including gastric leak (diagnosed on clinical features and imaging) and bleeding (as ascertained by need for re-exploration or need for blood transfusion in the postoperative period). Stricture, which is a late complication, was ascertained by requirement of endoscopic dilatation or any other surgical intervention for narrowing.

Statistical analysis

Spreadsheets were made using Microsoft^® Office Excel 2007 (Microsoft Inc., Redmond, WA). Statistical analysis was done using SPSS software version 16 (IBM, Armonk, NY). Descriptive statistics comprised means and standard deviations for quantitative variables. Individual comparison of parameters before and after the operation was analyzed by Student's t test. The relation between categorical variables in both groups in our study was studied by the chi-squared test. A P value of <.05 was considered to indicate statistical significance.

Results

During the study period, 30 patients were enrolled in each group. There was no significant difference in demographic parameters of the patients between the two groups (Table 1). The mean operative time in Group A was significantly increased (139±10 minutes) compared with Group B (117±19 minutes) (P=.02). The total duration of postoperative hospital stay in Group A was 4.3±0.9 days, whereas in Group B it was 4.4±0.9 days (P=.74). In both groups more than 95% of patients lost >50% of their excess weight after 1 year of LSG. There is no significant difference in weight loss and percentage excess weight loss between the two groups (Table 2).

Table 1.

Patient Demographics: Preoperative Parameters

Parameter	Group A (n=30)	Group B (n=30)	P value
Male/female	9/21	11/19	.72
Mean age (years)	38.3 (18–61)	37.5 (19–62)	.54
Mean height (cm)	158.8 (145–178)	161.5 (143–185)	.60
Mean weight (kg)	125.8 (94–186)	128.5 (97–206)	.74
Mean BMI (kg/m²)	49.8 (37–72)	49.3 (35–77)	.51

BMI, body mass index.

Table 2.

Mean Percentage Excess Weight Loss After Laparoscopic Sleeve Gastrectomy

	3 months	6 months	1 year
Group A	43±11%	59±16%	74±18%
Group B	45±12%	61±14%	72±18%
P value	.69	.64	.11

Impact on surgical complications

The primary end points of the study included major postoperative complications after LSG: leak, bleeding, and stricture. The overall complication rate was 5%. Two patients had early staple line leak. One patient had bleeding requiring reoperation in the postoperative period. None of the patients developed any stricture of the gastric sleeve. All the complications occurred in Group B (Table 3).

Table 3.

Major Surgical Complications After Laparoscopic Sleeve Gastrectomy

Surgical complication ^a	Group B (n=30)^b	P value
Leak	2	.246
Bleeding	1	.54
Total	3	.112

No cases of stricture in either group.

Group in which staple line was not oversewn.

In both patients with a leak, the result of the postoperative Day 1 oral Gastrografin study was reported as normal. However, in view of persistent unexplained tachycardia and fever, a contrast-enhanced computerized tomogram of the abdomen was done on postoperative Day 3. The contrast-enhanced computerized tomogram revealed a proximal leak as well as the perigastric and perisplenic collections. Both patients were managed conservatively with nasojejunal feeding, image-guided percutaneous drainage of collections (Fig. 1), and intravenous antibiotics. This approach was successful in 1 patient in whom the fistula healed completely 4 weeks after surgery. The other patient was a superobese female who was bedridden even before surgery. In this patient the initial sepsis was controlled successfully, and the leak was converted to a controlled gastrocutaneous fistula. She was discharged around 6 weeks after surgery with a controlled fistula output of 50–100 mL/day. Unfortunately, she died as a result of possible pulmonary embolism almost 3 months after surgery before any definitive procedure like endoluminal stenting could be planned.

FIG. 1.

Contrast-enhanced computerized tomogram of the abdomen shows a perigastric collection with a pig-tail catheter.

One patient, who had bleeding, developed increased drain output and hypotension 4 hours after surgery. The patient was immediately shifted to the operating room for re-exploration. On relaparoscopy, the peritoneal cavity was found to be filled with blood and blood clots. The source of bleeding could not be identified. The procedure was converted to open surgery. A spurting vessel was identified at the edge of the detached greater omentum. There was no bleeding from the staple line. The bleeder was ligated, and hemostasis was achieved. The patient recovered completely, was discharged on postoperative Day 5, and is doing well.

Discussion

LSG was initially used as the first step of a staged operation for superobese and/or high-risk patients.⁷ Subsequent reports suggested that LSG could be a promising stand-alone operation for treatment of morbid obesity.^2,3,8 Among the various complications of LSG, staple line leak is the most dreaded. Due to the long staple line in LSG, there is a propensity for leak, especially near the gastroesophageal junction.⁹ The incidence of gastric leak after LSG has been reported to be 0%–20%.^4,9,10,11 Depending on the etiology, leaks are classified into two types: mechanical and ischemic. Mechanical leaks usually appear within 48–72 hours after surgery and are mainly due to technical errors, inappropriate staple size, iatrogenic injury, and distal obstruction. Leaks that appear after 5 days of surgery are likely to be due to ischemia.⁹

Various methods have been used to prevent this complication, including use of reinforcement material like Seamguard^® (W.L. Gore & Associates, Inc., Flagstaff, AZ), Peri-Strips (Synovis Surgical Innovations, Deerfield, IL), fibrin glue sealants, and oversewing. Oversewing of the staple line with a continuous suture has been practiced widely as it is considered to prevent leak as well as staple line bleeding. Casella et al.¹² reported six leaks (mean BMI, >50 kg/m²) in a series of 200 LSGs. An oversewing running suture with 2-0 polydioxanone was performed in the last 100 cases. Only two leaks occurred in the last 100 patients compared with four leaks in the first 100 cases. The authors concluded that oversewing diminishes the leak rate but does not eliminate it completely. However, it could be argued that the improvement in leak rate could also be attributed to their increasing experience with the procedure and not merely to the efficacy of oversewing.

Burgos et al.¹⁰ reported seven leaks in a series of 214 LSGs. In all the patients, the staple line was reinforced by continuous suturing with 2-0/3-0 Maxon™ (Covidien, Mansfield, MA) suture. The majority of them presented as late leaks, which were attributed to the ischemic causes. The authors proposed that leaks are not a consequence of staple line failure or dehiscence; rather, they are due to the presence of gastric wall ischemia near the staple line, which is caused by thermal damage due to heat-producing energy sources for resecting the greater omentum from the greater curvature of the stomach. Staple line reinforcement with suturing does not have any protective role in ischemic leaks.

In a large multicentric series of 2834 patients of LSG,¹³ the reported leak rate was 1.5%. Of these 44 cases of leakage, 16 had reinforcement: 12 with oversewing and 4 with buttressing material. According to the authors, no conclusion regarding the issue of staple line reinforcement could be drawn from their study. Bellanger et al.¹⁴ have reported a zero leak rate in a series of 529 patients. They have stressed avoiding creating stricture at the incisura angularis. There is some evidence to suggest that a meticulous technique, which includes use of appropriate cartridge size, avoidance of distal narrowing, and careful use of energy devices, especially near the gastroesophageal junction, is more important in prevention of gastric leaks rather than just relying on staple line reinforcement.^4,5,10

Other reports have suggested that oversewing of the staple line has no role in preventing leak after LSG.^6,15 Nevertheless, in our study, none of the patients in the group with oversewing of the staple line had a leak. Two patients (3.3%), in whom the staple line was not reinforced with oversewing, had postoperative gastric leak. Both the leaks occurred in the early postoperative period (<72 hours), suggesting that mechanical factors rather than ischemic factors could have been responsible.

Our study, which was undertaken after an initial experience of more than 100 cases of LSG by a single surgeon, suggests that reinforcement of the staple line by oversewing may lead to a decrease in staple line leaks. However, we cannot make any dogmatic conclusions about the efficacy of oversewing of the staple line in view of the small sample size. As the incidence of leak rate is often very low, a randomized control trial with a sample size of approximately 10,000 patients would be required to reach an adequate conclusion regarding the status of SLR.⁶ As it is almost impossible to have such a large number even in a multicentric study, one has to depend on the results of meta-analysis of multiple smaller randomized studies. Our study adds to this growing repository of evidence. In a recent consensus statement that presented the data from 11 countries involving meta-analysis of more than 12,000 patients, oversewing has been accepted as a method of reinforcement, but the authors were unable to comment on its usefulness in preventing leaks.⁴

Besides doubtful efficacy, there are disadvantages of oversewing. The reinforcement of the staple line significantly increases the operative time and anesthesia-related risks. The mean operative time in Group A was increased (139±10 minutes) compared with Group B (117±19 minutes) (P=.02). Similarly, Konstantinos et al.¹⁶ reported that patients who underwent LSG with reinforcement had a longer operative time (69 minutes) than those without reinforcement (55 minutes), and this difference was statistically significant. In another randomized trial by Gentileschi et al.¹⁷ comparing three different techniques of SLR, oversewing led to increased operative time. However, in both the studies there was no statistically significant difference in terms of complication rates among the various groups.

Both of our patients had a leak only near the gastroesophageal junction. Leak after LSG usually appears just distal to the gastroesophageal junction.¹⁸ The reason for the leak in this area could be related to the development of high intraluminal pressure related to the long vertical tubulization of the stomach.¹⁹ Moreover, this pressure is amplified by the fact that the compliance of the sleeve is 10 times less than that of the complete stomach or the resected fundus.^19,20 This physical situation could be the culprit for the leaks because in humans, the thickness of the gastric tissue is different among the antrum, body, and fundus, with mean values reported to be 3.1 mm, 2.4 mm, and 1.7 mm, respectively.²⁰ For these reasons, the gastric tissue at the angle of His appears is prone to develop a leak.

Based on our experience, we have developed a protocol for diagnosis as well as management of leak after LSG. In a postoperative LSG patient with tachycardia and fever within the first 48 hours, a prompt relaparoscopy and intraoperative leak test (air insufflation test) is performed if there is suspicion of leak. If a leak is identified, that part should be reinforced with 2-0 polydioxanone in continuous seroserosal bites. But if a leak is diagnosed after 48 hours after LSG and the patient is stable, conservative management is done, which includes control of sepsis (parenteral antibiotics), nasojejunal feeding, and image-guided percutaneous drainage for localized intraperitoneal collections. For unstable patients, irrespective of the time of diagnosis, surgery should be done. De Aretxabala et al.²¹ reported nine leaks (three early and six late) after 789 cases of LSG. In all the 9 patients, a computerized tomography scan was used to confirm the diagnosis similar to both of our cases. The patients who underwent only drainage for collections improved symptomatically, whereas the patient whose defect was sutured had dehiscence of the manual suture with recurrence of leak and collection.

In both of our patients with leak, the postoperative Day 1 oral Gastrografin study was reported as normal. Subsequently, there was 1 patient who was suspected to have a leak on the Gastrografin study done on postoperative Day 1. It was decided to do an immediate relaparoscopy, but no leak was found. In another patient, relaparoscopy was done on postoperative Day 2 as the patient complained of unusually severe abdominal pain. The Gastrografin study was normal. Again, no leak was found during relaparoscopy, and both the patients recovered completely. From this experience, we have stopped doing a routine postoperative Gastrografin study. We do a strict monitoring of the postoperative signs and symptoms of the patients. Similarly, in a study of 904 gastric bypass patients by Carucci et al.,²² 48 leaks were reported on upper gastrointestinal contrast study; however, in 12 of 48 patients, no leaks were demonstrated in the early postoperative period. So the Gastrografin study findings may be misleading. Relaparoscopy should be done early, if clinical findings suggest a leak. However, we continue to perform an intraoperative leak test and recommend it to be used routinely.²³

Bleeding is another major complication in LSG. This bleeding usually occurs from the staple line but may also happen from the resected greater omentum. There are numerous methods, including buttressing material,²⁴ that decrease the chances of staple line bleeding. However, compression time after application of stapler is also important. In a study by Kasalicky et al.,⁵ 61 patients underwent LSG without reinforcement. They recommended 60 seconds of compression time instead of 20 seconds after closure of the stapler before firing. They had a 0% bleeding rate and strongly recommended that reinforcement is not required for preventing staple line bleeding.

In our study 1 patient (1.6%) had postoperative bleeding, which was from the resected greater omentum and not from the staple line. In our current practice, we are not using any reinforcement methods for the purpose of controlling bleeding from the staple line. We maintain a 60-second waiting period as suggested by Kasalicky et al.⁵ It is important to check the entire staple line thoroughly at the end of the procedure after withdrawal of the bougie. When significant oozing or bleeding is identified in the staple line, small clips can be used to control it.

Another uncommon but expected complication after LSG is postoperative stricture formation. No patient developed a stricture in our study group. However, prior to this study, we had 1 case of early post-LSG stricture formation due to overzealous suturing. It is advisable to ask the anesthetist to push the bougie distally, after the completion of oversewing, to ensure that there is no excessive narrowing. Dapri et al.²⁵ reported 9 cases of strictures after sleeve gastrectomy for which laparoscopic seromyotomy was done. The causes of these strictures were thought to be the small size of the bougie (34 French) and the reinforcement suturing over the staple line, which causes asymmetry of the sleeve that could lead to stenosis.

Conclusions

Oversewing of the staple line during LSG may lead to a reduction in early leak rate, although it may cause an increase in the duration of surgery and anesthesia-related risks. The incidence of staple line bleeding can be minimized by following meticulous technique and adequate compression of the stapler rather than placing undue emphasis on oversewing and expensive buttressing materials. Our study results contribute to a significantly growing body of evidence regarding the efficacy of SLR in LSG.

Footnotes

Disclosure Statement

No competing financial interests exist.

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