Original article
Use of bioabsorbable staple reinforcement material in gastric bypass: a prospective randomized clinical trial

Presented at the 23rd Annual Meeting of the American Society for Bariatric Surgery, June 26, 2006, San Francisco
https://doi.org/10.1016/j.soard.2007.03.244Get rights and content

Abstract

Background

Staple line failure, although uncommon, can result in significant morbidity and, even, mortality. Staple line buttressing has been developed to improve staple line strength, decrease bleeding, and minimize the risk of leak. Many different products are currently available. However, most have not been proved in clinical trials for their clinical relevance.

Methods

From April 2004 to March 2005, 48 morbidly obese patients who had undergone laparoscopic Roux-en-Y gastric bypass were enrolled in this study. The patients were randomly allocated to 2 groups according to whether polyglycolide acid and trimethylene carbonate (Seamguard) was (group 1, n = 24) or was not (group 2, n = 24) used in an investigator-initiated study. All patients underwent barium radiography at 3 and 12 months postoperatively.

Results

Peri- and postoperative mortality were absent. The intraoperative methylene blue test was positive in 1 patient in group 2. No conversion to laparotomy was needed. No patient required reoperation or transfusion for extraluminal bleeding, and no anastomotic leaks were detected in either group postoperatively. The mean number of clip instruments used was significantly lower in group 1 patients (2 versus 22, P <.0001, odds ratio 121.0, 95% confidence interval 12.5–1491). The operative time was significantly less in group 1 (115 ± 30.0 min, range 85–210) compared with that in group 2 (150 ± 51.7 min, range 90–240; P <.05). The postoperative hemoglobin level was significantly greater in group 1 (12.47 ± 1.7 mg/dL, range 9.2–14.8) compared with that in group 2 (11.1 ± 1.9 mg/dL, range 8.1–14.6; P <.05). Gastrogastric fistula formation was detected in 3 patients (12.5%) in group 2, with no statistically significant difference (P = .2).

Conclusion

The results of our study have shown that synthetic reinforcement material minimizes staple line bleeding and reduces the operative time, with no animal source contamination. No adverse events related to the resorbable buttressing material were observed.

Section snippets

Methods

Patients selected to undergo gastric bypass surgery for the treatment of morbid obesity were enrolled in this study. Eligible patients were >18 years of age and had a body mass index of ≥40 kg/m2. Those patients with a body mass index of ≥35 kg/m2 and co-morbidities according to the guidelines of the National Institutes of Health Consensus Development Conference Statement of March 25–27, 1991 were also enrolled in this study [13]. The exclusion criteria for the study were the presence of

Results

A total of 48 patients undergoing laparoscopic RYGB were randomly allocated to 2 groups according to the use of polyglycolide acid and trimethylene carbonate (Seamguard) in an investigator-initiated study. Both groups consisted of 24 patients. The 2 groups were fairly well matched with respect to body mass index, age, and gender ratio (Table 1). The minimal follow-up was 12 months.

For gastric pouch construction, 4.0 ± .59 and 4.3 ± .56 staple magazines were used in groups 1 and 2, respectively (

Discussion

The complications associated with the use of surgical stapling devices include bleeding, technical failure of the instruments, inadequate approximation of the tissues, stricture, enteric leakage, and fistula [15]. Randomized prospective clinical trials have demonstrated the safety and effectiveness of staple line reinforcement using bovine pericardial strips [9], [10]. However, reinforcement with bovine pericardial strips has drawbacks. This material is nonresorbable [16] and can persist as a

Disclosures

The authors have no commercial associations that might be a conflict of interest in relation to this article.

References (26)

  • M.F. Shamji et al.

    Surgical staple metalloptysis after apical bullectomy: a reaction to bovine pericardium?

    Ann Thorac Surg

    (2002)
  • H. Buchwald et al.

    Bariatric surgery: a systematic review and meta-analysis

    JAMA

    (2004)
  • M. Gagner et al.

    Laparoscopic isolated gastric bypass for morbid obesity

    Surg Endosc

    (1999)
  • H.D. Higa et al.

    Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients—what have we learned?

    Obes Surg

    (2000)
  • P.R. Schauer et al.

    Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity

    Ann Surg

    (2000)
  • A.C. Wittgrove et al.

    Laparoscopic gastric bypass, Roux-en-Y—500 patients: technique and results with 3–60 month follow-up

    Obes Surg

    (2000)
  • L.D. MacLean et al.

    Stomal ulcer after gastric bypass

    J Am Coll Surg

    (1997)
  • S.G. Cucchi et al.

    Gastrogastric fistulas: a complication of divided gastric bypass surgery

    Ann Surg

    (1995)
  • F.H. Chae et al.

    Anastomotic staple-line reinforcement enhances the safety of laparoscopic Roux-en-Y gastric bypass for morbid obesity

    Surg Endosc

    (2001)
  • S.A. Shikora et al.

    Reinforcing gastric staple-lines with bovine pericardial strips may decrease the likelihood of gastric leak after laparoscopic Roux-en-Y gastric bypass for morbid obesity

    Obes Surg

    (2003)
  • L. Angrisani et al.

    The use of bovine pericardial strips on linear stapler to reduce extraluminal bleeding during laparoscopic gastric bypass: prospective randomized clinical trial

    Obes Surg

    (2004)
  • D.M. Downey et al.

    Increased burst pressure in gastrointestinal staple-lines using reinforcement with a bioprosthetic material

    Obes Surg

    (2005)
  • E.C. Consten et al.

    Intraluminal migration of bovine pericardial strips used to reinforce the gastric staple-line in laparoscopic bariatric surgery

    Obes Surg

    (2004)
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