Alexander Aurora, MD, Alan Saber, MD, Leena Khaitan, MD. Dept of Surgery, University Hospitals Case Medical Center
INTRODUCTION: In bariatrics a small complication can be lethal. Bariatric surgeons may more easily approve the use of products thought to decrease the risk of bleeding and prevent leak. Staple-line reinforcement has become commonplace in bariatrics in the absence of significant data to support improved patient care or outcomes. The objective of this study was to systematically review the evidence for use of staple line reinforcement in bariatric surgery.
METHODS: An electronic literature search of MEDLINE database plus manual reference checks of articles published on laparoscopic gastric bypass surgery, bleeding and the use of staple-line reinforcement. We analyzed the significance of staple-line reinforcement on bleeding and leak.
RESULTS: We analyzed 5 comparative studies of which 3 were randomized control trials (level one evidence). None of the 5 comparative studies including 610 patients demonstrated any clinically significant difference in blood loss (see table). Two studies documented a significant increased use of hemaclips, a third documented “more bleeding sites” (amount of bleeding quantified subjectively). One comparative study found a 2% non-reinforced staple-line leak rate. There were zero leaks in the comparative group with staple-line reinforcement. Operative time was significantly increased in the non-reinforced staple-line groups. One study documented a significant difference in cost of $1600/case when using staple-line reinforcement.
In secondary analysis, 19 case series (9831 patients) using non-reinforced staple-lines and 5 case series (1493 patients) using reinforced staple-lines reported on bleeding complications after laparoscopic gastric bypass surgery. Clinically significant bleeding was seen in 277 of 9831 (2.4 ± 1.5%). Fifty of the 1493 (2.4 ± 1.9%) had clinically significant bleeds in the group with staple-line reinforcement. There was no difference in staple line bleeding between reinforced and non-reinforced staple-lines.
CONCLUSION: Staple-line reinforcement is commonly used in bariatric surgery. There is currently little level one evidence to support a benefit. A multitude of factors may influence the effect on bleeding and wound healing including use of heparin, age, comorbidities. Further studies which take into account these factors may provide stronger evidence to explain why bariatric surgeons embrace this technology.
R= reinforced, NR non-reinforced, OR= operative time, EBL= estimated blood loss, ND= not discussed, Mgt= management, SG= Seamguard, PSD=Peristrips Dry, * significant difference, # not at staple line
Reference R/NR OR EBL Mgt Leak Strip
Miller 2006 24/24 115/150* ND clips 2/22 0/0 SG
Nguyen 2005 17/17 135/138 84/129 OR 0/0 SG
Angrasani 2004 50/48 120/220* ND clips 5/23 0/6# PSD
Saber 2008 40/40 120/220* 66/73 suture 0/0 SG
Shikora 2003 250/100 160/212 90/75 suture 0/2 PSD
Program Number: S065