Prospective and Randomized Comparison of Two Techniques of Staple Line Reinforcement During Open Roux-en-Y Gastric Bypass: Oversewing and Bioabsorbable Seamguard ®

Abstract

Aims:

Surgical staple line dehiscence usually leads to severe complications. Several techniques and materials have been used to reinforce this stapling and thus reduce the related complications. The objective was to compare safety of two types of anastomotic reinforcement in open gastric bypass.

Methods:

A prospective, randomized study comparing an extraluminal suture, fibrin glue, and a nonpermanent buttressing material, Seamguard^®, for staple line reinforcement. Fibrin glue was excluded from the study and analysis after two leaks, requiring surgical reintervention, antibiotic therapy, and prolonged patient hospitalization.

Results:

Twenty patients were assigned to the suture and Seamguard reinforcement groups. The groups were similar in terms of preoperative characteristics. No staple line dehiscence occurred in the two groups, whereas two cases of dehiscence occurred in the fibrin glue group. No mortality occurred and surgical time was statistically similar for both techniques. Seamguard made the surgery more expensive.

Conclusion:

In our service, staple line reinforcement in open bariatric surgery with oversewing or Seamguard was considered to be safe. Seamguard application was considered to be easier than oversewing, but more expensive.

Introduction

Roux-en-Y gastric bypass has become the most frequently used procedure for the treatment of morbid obesity, with a total of 140,000 cases in the United States in 2005.¹ The division of the stomach with linear staples is one of the fundamental steps of the technique. Consequently, flaws in the stapling line may result in serious complications, increasing the number of days of hospitalization and hospital costs. The rates of staple line dehiscence are about 0.5%–6%,^2–4 and bleeding rates are 3%–4%.⁵ It should be pointed out that the occurrence of dehiscence is associated with a 10% mortality rate.⁶

Various techniques and materials have been used to reinforce the staple line and thus reduce the related complications: full-thickness or extraluminal suture, fibrin glue, or staple-line buttressing with permanent and nonpermanent materials.⁷ There are controversies in the literature regarding all of these options, with some surgeons opting not to reinforce the staple line.

An aspect to be taken into consideration is the difference between the staplers used for open gastric bypass and those used for laparoscopy. Laparoscopic staplers contain three staple lines for each side of the sectioned tissue, whereas the staplers used for open surgery only contain two staple lines. Although the first impression may be that six-row stapler would be safer than four-row stapler, the literature does not support this affirmation and shows no difference between them in terms of leaks.^8,9 In Brazil, the public health system only pays the amount sufficient for open surgery.

Thus, the initial objective of the present study was to compare three options of staple line reinforcement (extraluminal suture—fibrin glue—or nonpermanent buttressing material—Seamguard^®) mainly in terms of the safety of the materials and secondarily in terms of the practicality of application of each one in open gastric bypass for the treatment of morbidly obese patients. Because of two cases of pouch leak with severe consequences, the group with fibrin glue was excluded from the study and analysis.

Materials and Methods

This was a prospective, randomized study that was conducted on 60 patients subjected to open-banded Roux-en-Y gastric bypass for the treatment of morbid obesity at the University Hospital, Faculty of Medicine of Ribeirão Preto-University of São Paulo (HCFMRP-USP), São Paulo, Brazil. Randomization was performed on the day of surgery, when one of three envelopes containing the options of staple line reinforcement (oversewing—fibrin glue [Quixil™]—or Seamguard) was picked by drawing lots immediately before stapling. Each technique was to be applied to 20 patients.

All patients were older than 18 years and their body mass index was >40 kg/m² or ≥35 kg/m² with comorbidities. The study was approved by the Research Ethics Committee of HCFMRP-USP and also in National Health Council and Ethics in Research National Committee of the Brazilian Health Ministry. All patients gave written informed consent to participate.

The surgical technique used was open Roux-en-Y gastric bypass with a 100-cm bileopancreatic loop and a 100-cm alimentary loop, a 30-mL gastric pouch, and a silastic ring with a circumference of 6.2 cm. After intraoperative reinforcement, the staple line was tested by infusion of methylene blue. All patients left the operating room wearing an abdominal drain (Blake^® 19F; Ethicon), which was left in place up to the seventh postoperative day, when a new methylene blue test was performed. Only two surgeons were responsible for all surgeries.

For staple line reinforcement, extramucosal continuous oversewing with unabsorbable 3.0 polypropylene suture was used for group I (n=20), both on the side of the gastric pouch and on the side of the excluded stomach. In this group, gastric division was performed with a 75-mm linear stapler with a 3.5-mm loading unit.

Group II, reinforced with fibrin glue (initially n=20 patients), Quixil (OMRIX Biopharmaceuticals Ltd., commercialized in Brazil by Johnson & Johnson), was excluded and no more patients were operated with this reinforcement technique after the second case of gastric pouch leak.

The third reinforcement technique used (group III, n=20) was Seamguard (W.L. Gore & Associates, Inc.), a bioabsorbable material consisting of a polyglycolic acid and trimethylene carbonate mesh. As suggested by the Seamguard manufacturer, the material was used to coat the blades of a 75-mm linear cutting stapler with 4.8-mm loading unit. This material is completely absorbed within 6 months, keeping ∼70% of its tensile strength for 4–6 weeks.

The patients remained in the hospital for 4 days after surgery and returned on the seventh day for drain removal. Return visits were then scheduled weekly for the first month and monthly thereafter.

The main evaluation concerned the safety of the reinforcement technique used. To this end, the clinical condition of the patient was analyzed during the postoperative period and methylene blue tests were performed to check leakage through the staple line. Total surgical time was also determined and the surgeon performed a subjective evaluation of the ease of application of the reinforcement technique.

The INSTAT 3.0 software was used for the following statistical tests: Kolmogorov-Smirnov test for the determination of normal sample distribution, analysis of variance for comparison of the three techniques regarding the variables, and the unpaired t-test for the comparison of two groups. The Fisher exact test was used to compare the groups two by two for the gender variable. The level of significance was set at P<.05 in all analyses.

Results

From August 2009 to April 2010, we studied 40 patients as follows:

• Group I—suture: n=20 patients

• Group II—Seamguard: n=20 patients.

The two groups were similar regarding preoperative characteristics, as shown in Table 1. There was no dehiscence of the staple line or any major complication. No mortality occurred in the series.

Table 1.

Comparison of the Preoperative Characteristics of the Patients in the Oversewing or Seamguard ^® Groups

	Group I Suture	Group II Seamguard ^®	P value
Age	40.42±10.23	39.5±9.62	.7737
Gender	2♂/18♀	5♂/15♀	.4075
Maximum weight (kg)	132.28±17.49	143.55±31.12	.1751
Maximum BMI^a	50.87±5.57	53.29±8.55	.3650
Preoperative weight (kg)	114.95±14.34	125.38±24.83	.1194
Preoperative BMI	44.31±5.04	46.64±7.15	.2507
Weight loss (kg)^b	17.22±6.61	18.21±8.88	.6983

Data are reported as mean±SD and were analyzed by the unpaired t-test.

BMI, body mass index (kg/m²).

Preoperative weight loss.

Regarding surgical time, the groups did not differ significantly from one another (Table 2). It should be pointed out that this is a university hospital where surgical time is long, with a general mean of 03:58 hours, because training residents perform some of the surgical steps and many of these patients had to be subjected to simultaneous cholecystectomy because of the presence of cholelithiasis.

Table 2.

Comparison of the Surgical Times for the Groups Studied

	Surgical time
Group I—suture	04 h:08 min±01 h:09 min
Group II—Seamguard^®	03 h:45 min±01 h:00 min

Data are reported as mean±SD and were analyzed by the unpaired t-test for comparison of groups. P=.2482 for comparison of the Suture and Seamguard groups.

Subjective evaluation of the ease of application of the reinforcement method by the two senior surgeons involved in the study showed that the greatest difficulty concerned the reinforcement with suture, especially in more obese patients and in patients with livers of larger dimensions. Seamguard was considered to be of easy preparation and application, although the surgeons observed that the last stapling for stomach sectioning close to the Hiss angle caused the Seamguard reinforcement to slip and to stick to the blades of the stapler when the structures to be stapled were pushed, with the need to fix the material to the tip of the stapler with cotton suture.

It was observed that when the Seamguard was used, the surgery costs was $242.00 higher than when the oversewing technique was applied, including all surgical and anesthetics expenses.

Discussion

The first consideration to be presented here is that in Brazil we still perform open bariatric surgery at some Hospitals, because the Public Health System only pays the equivalent of US$2560.00 for the entire surgical treatment of morbidly obese patients, including the expenses of the surgical center and of hospitalization. In this scenario, routine laparoscopic surgery for this procedure is unviable.

The option of not including a control group with no staple line reinforcement was due to our previous experience of staple line dehiscence in other open gastric and intestinal surgeries when the staple line was not reinforced. This option of always reinforcing the staple line was confirmed with the present study after the occurrence of the two cases of dehiscence with the use of fibrin glue. Before the present study, the only option available to us was oversewing. This reinforcement modality is questioned in the literature, because it can lead to a greater incidence of staple line failure due to ischemia or tissue tearing.¹⁰

There are several causes of staple line dehiscence, but they can be assigned to two major groups: early mechanical and tissue causes usually due to failure of the stapling mechanism or to the thickness of the stapled tissue, and ischemic causes usually occurring at a later time and at a lower frequency between the fifth and seventh day.¹⁰

The technical difficulty of reinforcing the staple line of the gastric pouch by oversewing in open bariatric surgery, especially in superobese patients with much enlarged livers, together with the fact that our rate of dehiscence of this staple line was not zero in a previous series (3% of 480 operated cases) motivated us to look for other techniques of staple line reinforcement.

On the basis of the review article by Lee et al.,¹¹ the use of fibrin sealant has been considered to be one of the most promising types of staple line reinforcement in laparoscopic bariatric surgery. However, in our experience with this type of bariatric surgery, after eight cases of reinforcement with this material there were two cases of staple line dehiscence, a fact that caused this technique to be considered unviable in our service.

Since the introduction of buttressing materials to reinforce the suture repair of the staple line in pneumectomies, preventing air escape, the use of these materials has become widespread in other surgeries.^12,13 Studies have shown reduced rates of bleeding and anastomosis leakage with its use in colon surgeries¹⁴ and in appendectomies.¹⁵ Lower rates of intraoperative bleeding, shorter surgical times, and reduced abscess formation with its use in bariatric surgery¹⁶ have been reported.

There are two main types of reinforcement materials, that is, those consisting of nonabsorbable material and those consisting of absorbable materials. Although nonabsorbable materials have been shown to be effective,¹⁷ a great problem related to their use is migration of the material to the gastric lumen,^18,19 a complication that does not occur when absorbable material is used. Only one relevant study published by Shikora et al. in 2008 demonstrated a higher rate of fistulas when absorbable reinforcement (Seamguard) was compared with nonabsorbable material.⁷ However, this was not a randomized study and the groups were compared at different historical times. Despite the small sample size of our study, none of the 20 patients operated with this reinforcement material presented staple line dehiscence.

Several literature reports have described the results of the use of Seamguard for staple line reinforcement in bariatric surgery,^20,21 but few of them were prospective, randomized clinical trails.²²

We conclude that staple line reinforcement with oversewing or Seamguard is considered safe in open bariatric surgery. Although the surgical time does not differ between suture reinforcement with extraluminal suture or Seamguard, subjective evaluation by the surgeons indicates that the latter technique is of simpler application than suture, especially for superobese patients with large hepatomegaly. However, Seamguard was a more expensive reinforcement technique.

Footnotes

Disclosure Statement

Seamguard was provided by Intermedical Corp. and Quixil by Ethicon gratis for the study with the understanding that the results of the study would be published regardless of outcome. All authors do not have any financial interest or relationship with the two companies.

Authors' Contribution

G.V. Rosa: Substantial contributions to conception and design; drafting the article or revising it critically for important intellectual content. W. Salgado Jr.: Substantial contributions to conception and design; drafting the article or revising it critically for important intellectual content; final approval of the version to be published. C.B. Nonino-Borges and R. Ceneviva: Substantial contributions to conception and design; final approval of the version to be published.

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