Clinical Data Summary
GORE® SEAMGUARD® Reinforcement has shown proven success in reducing leaks and bleeding in multiple applications.1
|
Type of Procedure |
# of Patients |
Complication |
Rate |
|---|---|---|---|
| Gastric Bypass | 2593 | Leaks Bleeding Fistula formation Strictures Internal hernia Erosions |
0 - 0.7% 0 - 0.75% 0 0 - 2.5% 0 - 0.8% 0 |
| Sleeve Gastrectomy | 2436 | Leaks | 0 - 1.92% |
| Colorectal | 295 | Leaks Bleeding Stricture |
0 - 3.4%* 0 0 |
| Solid Organ | 217 | Leaks Fistula formation |
0 - 4% 0 |
| Thoracic | 260 | Leaks (requiring reoperation) | 0 |
*including high risk anastomosis
|
|
# of Studies |
# of Patients |
|---|---|---|
| Bariatric | 35 | 5029 |
| Colorectal | 7 | 295 |
| Solid Organ | 12 | 217 |
| Thoracic | 2 | 260 |
| TOTAL | 56 | 5801 |
Reduction in Leaks
Clinical data shows a significant reduction in leaks when the staple line is strengthened with GORE® SEAMGUARD® Reinforcement.
A meta-analysis of leaks following laparoscopic sleeve gastrectomy demonstrated a significant reduction in leaks using GORE® SEAMGUARD® Reinforcement.2
Meta-analysis of leak following sleeve gastrectomy
“Patients in whom synthetic PGA/TMC staple line reinforcement material was applied during LSG had no postoperative leaks or hemorrhages from the staple line. The differences in leak rate between the reinforcement-material group and the no-reinforcement-material group was significant (p=0.045).” – Durmush et al.3
Use of [GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement] to prevent pancreatic leak following distal pancreatectomy
“The use of [GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement] is quickly becoming a common adjunct in distal pancreas resections. Our study shows a lower incidence of pancreatic leak after distal pancreatectomy with the use of this staple line reinforcing product.” –Imagawa et al. 4
Reduction in Bleeding
Staple line reinforcement was developed more than a decade ago in an effort to strengthen the integrity of the staple line and minimize bleeding. Staple line reinforcement employs a buttressing material that strengthens the staple line and provides a compressive effect on the staple line, leading to improved hemostasis.
Our study shows that GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement is effective in decreasing bleeding complications related to the long staple line associated with LVSG. Chiasson et al5
Miller et al.6 showed significantly reduced bleeding in gastric bypass procedures (p<0.05)*
- Lower mean blood loss
- Fewer staple line bleeding sites
- Less time to staple line hemostasis
Nguyen et al.7 showed significantly reduced bleeding in gastric bypass procedures (p<0.05)*
- Less clips used
- Higher post-op hemoglobin
Consten et al.8 showed significantly reduced bleeding in gastric bypass procedures (p<0.05)*
- Lower mean blood loss
References
- W. L. Gore & Associates, Inc. Clinical Performance with Staple Line Reinforcement. Scientific Literature Analysis (n = 4689 patients). Flagstaff, AZ: W. L. Gore & Associates, Inc; 2013.
- Gagner M, Buchwald JN. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surgery for Obesity & Related Diseases 2014;10(4):713-723.
- Durmush EK, Ermerak G, Durmush D. Short-term outcomes of sleeve gastrectomy for morbid obesity: does staple line reinforcement matter? Obesity Surgery 2014;24(7):1109-1116
- Yamamoto M, Hayashi MS, Nguyen NT, Nguyen TD, McCloud S, Imagawa DK. Use of Seamguard to prevent pancreatic leak following distal pancreatectomy. Archives of Surgery 2009;144(10):894-899.
- Chiasson PM, Burpee SE, Corrigan R. Laparoscopic Vertical Sleeve Gastrectomy (LVSG): Efficacy of Using GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement to Buttress the Staple Line. Abstract presented at the 25th Annual American Society for Metabolic & Bariatric Surgery Meeting (ASMBS):June 15-20, 2008; Washington, DC. Surgery for Obesity & Related Diseases 2008;4(3):332-333. Abstract P54.
- Miller KA, Pump A. Use of bioabsorbable staple reinforcement material in gastric bypass: a prospective randomized clinical trial. Surgery for Obesity & Related Diseases 2007;3(4):417-422.
- Nguyen NT, Longoria M, Welbourne S, Sabio A, Wilson SE. Glycolide copolymer staple-line reinforcement reduces staple site bleeding during laparoscopic gastric bypass. A prospective randomized trial. Archives of Surgery 2005;140(8):773-778.
- Consten, ECJ, Gagner M, Pomp A, Inabnet WB. Decreased bleeding after laparoscopic sleeve gastrectomy with or without duodenal switch for morbid obesity using a stapled buttressed absorbable polymer membrane. Obesity Surgery 2004;14(10):1360-1366.