Staple line reinforcement with new biomaterial increased burst strength pressure: an animal study

doi:10.1016/j.soard.2006.03.006

Surgery for Obesity and Related Diseases

Volume 2, Issue 3, May–June 2006, Pages 397-399

https://doi.org/10.1016/j.soard.2006.03.006 Get rights and content

Abstract

Background

Most bariatric operations rely on stapler devices. Although today staplers are extremely safe, efficient, and reliable, a potential risk exists for staple line failures, leading to three complications: leaks, fistulas, and bleeding. Porcine small intestinal submucosa strip applied over the staple line suture might help prevent these problems.

Methods

Forty animals (canine model developed at the University of São Paulo, São Paulo, Brazil) underwent general anesthesia and laparotomy. One nonreinforced staple line suture and one staple line suture reinforced with Surgisis SLR was created in each animal. The burst strength pressure of the 80 staple line sutures was obtained. Suture line bleeding and the ease of use of the membrane were also noted. The data were compared (Student’s t test). The dogs were euthanized after the procedure. Two surgeons with experience in stapler devices performed all procedures.

Results

The mean ± SD burst pressure was 209.26 ± 76.41 mm Hg and 441.33 ± 128.64 mm Hg for the stapler line without and with the biodegradable membrane, respectively. The difference was statistically significant (P = .002). No in vivo suture line bleeding occurred. The biodegradable membrane was easy to use.

Conclusion

The biodegradable membrane was able to increase the burst strength pressure of the bowel segment staple line. It might help prevent some causes of staple line leaks.

Section snippets

Methods

Forty animals (canine model developed at the University of São Paulo, São Paulo, Brazil) underwent general anesthesia. Two surgeons with experience with stapler devices performed all procedures. A midline laparotomy was performed in all animals, and a segment 20-cm distal to the ligament of Treitz was identified. A 45-mm linear stapler (EndoGIA, AutoSuture, U.S. Surgical, Norwalk, CT) with a blue cartridge (3.5-mm staple depth) was fired to divide the small intestine. The small bowel 10 cm

Results

We studied 40 staple line sutures created without Surgisis and 40 staple line sutures created with Surgisis. In three bowel segments with Surgisis, the rupture occurred through the bowel wall and not through the staple line. These data were excluded from the final statistical analysis.

The mean burst pressure was 209.26 ± 76.41 mm Hg of the stapler line without Surgisis and 441.33 ± 128.64 mm Hg with Surgisis. Fig. 2 shows the burst pressure results. The difference was statistically significant (

Discussion

The ideal method or material to prevent staple line complications should be easy to use and not increase the operative time; be biocompatible, behaving better during infection than other synthetic materials; increase tissue strength (assessed by burst strength experimental test), protecting the staple lines; not add to tissue thickness, preventing anastomotic occlusion; not result in stapler malfunction; and be cost effective.

A variety of methods have been used to prevent suture line failures,

Conclusion

The porcine small intestinal submucosa (Surgisis) membrane was able to significantly increase the burst strength pressures of the stapler line sutures. This material might help prevent suture line complications.

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Cited by (30)

7.39 Staple line reinforcement materials
2017, Comprehensive Biomaterials II
Despite refinements in the field of gastrointestinal (GI) surgical stapling, anastomotic leakage and bleeding still remain a serious problem associated with substantial morbidity and mortality. To prevent or reduce these complications, a diversity of staple line reinforcement techniques have been developed. Many different forms of staple line reinforcement are available and have been described in the literature. Reinforcement methods can be material applied exogenously to the staple line or incorporated into the staple line. Furthermore, materials available differ from nonabsorbable and semiabsorbable to fully absorbable. The use of GI staple line reinforcement has been investigated in several studies, especially in patients undergoing gastric or obesity surgery, but it is a relatively new method for colorectal surgery. Staple line reinforcement seems to be an effective technique in reducing complications in stapled anastomosis when appropriate buttressing material is used. These advantages mainly comprise a reduction in postoperative bleeding of the staple line after gastric sleeve resection. Some studies also report less anastomosis or staple line leakages with application of these techniques. More recent studies, however, have demonstrated a higher incidence of pancreatic fistula formation after staple line reinforcement.
This chapter provides an overview of all available staple line reinforcement materials and their applications. Furthermore, we summarize the currently available literature regarding this topic.
Technique or technology? Evaluating leaks after gastric bypass
2016, Surgery for Obesity and Related Diseases
Citation Excerpt :
Given the collaborative nature of our consortium and our access to an expansive clinical registry, we had a unique opportunity to evaluate variation in technique as well as use of operative devices across a broad spectrum of surgical practices. It has been found in animal models that buttressed gastrointestinal staple lines maintain seam integrity at a significantly higher intraluminal pressure than nonbuttressed staple lines [17–19]. However, there has been no clear evidence to support that improvement in seam quality results in a decreased likelihood of experiencing a leak in gastric bypass surgery.
To assess the relationship between technique and surgical devices on anastomotic and staple-line leaks after laparoscopic Roux-en-Y gastric bypass.
Leaks after bariatric surgery remain a major source of morbidity and mortality. The association of surgical technique and devices with leaks after gastric bypass is poorly understood.
Multi-centered study that included teaching and non-teaching hospitals that participate in a statewide consortium for quality improvement using a payer-funded outcome registry.
We analyzed data from the Michigan Bariatric Surgery Collaborative and performed a case-control study comparing patients who sustained a leak with those who did not after primary laparoscopic Roux-en-Y gastric bypass. A total of 71 (.44%) patients with leaks were identified between January 2007 and December 2011. The leak group was matched 1:2 to a control group (nonleak) based on procedure type, age, body mass index, sex, and the year in which the procedure was performed. Technique-specific case characteristics and device-specific factors were assessed by reviewing operative notes from all primary bariatric procedures in our study population.
The rate of leak decreased during the study period, and there was a significant downward trend (slope estimate: –.19961%, P = .0372). After performing multivariate analysis, the type of anastomosis (circular stapler, hand-sewn, or linear stapler) and stapler manufacturer were not associated with leaks. The use of buttressing material was associated with a higher rate of leaks (odds ratio: 8.79 [95% confidence interval: 2.49–31.01], P = .0007), whereas the use of fibrin sealant was associated with a lower rate of leaks (odds ratio .11 [95% confidence interval: .03–.41], P = .0013). These findings could not be explained by differences in measures of surgeon performance.
Leak rates after laparoscopic gastric bypass have fallen in Michigan despite variations in technique and device utilization. Although the type of anastomosis and stapler manufacturer do not appear to be significantly associated with leaks, it appears that the use of buttressing material was more common in cases in which leaks occurred, whereas the use of fibrin sealant was not. Given the complex interplay of multiple variables that affect surgical outcomes, future studies justifying the benefits of operative devices should be evaluated prospectively in the context of surgeon technique and skill.
Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: A multicenter study
2014, Surgery for Obesity and Related Diseases
Citation Excerpt :
However, standardization of SLR is still lacking due to the absence of a clear advantage of one method over the others. Several reports demonstrated specific SLR-related complications, including intraluminal migration of bovine pericardium strips, tissue ischemia, or sleeve stenosis after oversewing the staple line [19,20]. In a prospective, randomized trial, Dapri et al. reported no significant difference in leaks between SLR with Seamguard or oversewing compared with a no-SLR group [21].
Laparoscopic sleeve gastrectomy (LSG) is an approved primary procedure for morbid obesity, but it is associated with serious complications, such as staple line leaks and bleeding. The objective of this study was to assess the effectiveness of staple line reinforcement (SLR) in reducing leaks and bleeding after LSG.
A total of 1162 patients underwent LSG (305 males, 857 females). The mean age was 43.7 years and the mean body mass index was 48 kg/m². The patients were divided into 6 groups based on the type of SLR, including a no-SLR control group, with evaluation of leaking and bleeding risk and correlation of patients’ characteristics with complications.
A total of 189 patients underwent LSG without reinforcement. The SLR method was oversewing in 476 patients, bovine pericardium in 312, synthetic polyester in 76, glycolide/trimethylene copolymer in 63, and thrombin matrix in 46. The overall leak frequency was 2.8%; higher with synthetic polyester (7.8%), 4.8% with no reinforcement, and lower with bovine pericardium strips (.3%; P<.01). Postoperative hemorrhage occurred in 35 patients (3%), with a higher frequency being observed without SLR (13.7%; P = .02). Only diabetes was a risk-factor for a leak (P< .01).
SLR with bovine pericardium strips significantly reduced the leak risk. Postoperative bleeding was significantly lower with all SLR-methods, although there was no significant difference among the various techniques. Patients with type II diabetes had a higher risk of staple line leak after LSG. Further randomized, controlled studies are needed to improve our understanding of the efficacy of SLR during LSG.
Surgisis Fistula Plug: The United States Experience
2009, Seminars in Colon and Rectal Surgery
Citation Excerpt :
Surgisis is manufactured into sheets of varying size and thickness and has been applied to a host of surgical indications. Hernia repair (inguinal, ventral, paraesophageal), urethral sling, and stapler line reinforcement with Surgisis are reported applications.28-31 The xenograft is resistant to infection, produces no giant cell foreign body reaction, and becomes repopulated with native host cell tissues within 12 weeks.32,33
Anorectal fistulae are a heterogeneous group of disorders that can cause significant pain, social impairment, hygienic problems, and, rarely, sepsis. Surgery is the mainstay of treatment for anorectal fistulae, yet no one procedure is universally efficacious and safe. Simple fistulae can often be treated by simple fistulotomy, but complex fistulae present a more complicated scenario—effective surgical treatment options are compromised by increased risk of incontinence. Likewise, safe treatment alternatives have low risk of postoperative incontinence but low success rates. The Surgisis AFP appears to be an effective and safe treatment alternative for complex fistula, including Crohn's fistula, based on initial reports.
Comparison of permanent and nonpermanent staple line buttressing materials for linear gastric staple lines during laparoscopic Roux-en-Y gastric bypass
2008, Surgery for Obesity and Related Diseases
Citation Excerpt :
As with PSDV, it is considered remodelable. In 2 independent animal studies investigating burst pressure, both Pinheiro et al. [16] and Downey et al. [17] found that small intestinal staple lines buttressed with Surgisis could sustain significantly greater pressures before failing. To date, no human studies of this product have been published.
Several publications have suggested that staple line buttressing might decrease staple line bleeding, increase burst pressure, and decrease the likelihood of acute failure resulting in leak. Currently, permanent and nonpermanent options are available. However, concern has been raised about the permanent buttress material and its potential for delayed strip expulsion. This study analyzed our experience with 3 different buttressing materials for creating the gastric division during laparoscopic Roux-en-Y gastric bypass.
From July 5, 2001 to May 30, 2007, 1451 consecutive patients underwent laparoscopic gastric bypass with buttressing material used for the stapled creation of the gastric pouch. Peristrips Dry (PSDs), permanent bovine pericardial strips, were used in 926 cases from July 5, 2001 to October 11, 2005. Seamguards, a synthetic bioabsorbable product, were used in 145 cases from November 2, 2004 to July 18, 2006, and PSD Veritas, remodelable, nonpermanent bovine pericardial strips, were placed in 380 patients from October 11, 2005 to May 30, 2007. All products were applied to the 60-mm-long, 3.5-mm cartridges of the EndoGIA II stapler. The ease of use, operative complications, visual bleeding, and postoperative leaks were recorded.
The patient characteristics were comparable for all groups. All products were easy to load on the stapler, and no operative complications related to the use of the buttress materials occurred. The incidence and severity of staple line bleeding was not specifically calculated but was visually noted to be minimal in all cases. Of the 3 groups, 4 contained leaks occurred in the Seamguards group, and all were successfully managed nonoperatively. No acute leaks were discovered in the PSD or PSD Veritas groups. This difference was statistically significant (p <.001).
Neither the PSDs or PSD Veritas group exhibited staple line complications. However, 4 leaks occurred in the patients who had Seamguards incorporated into their gastric pouch linear staple lines.
Profiling surgical staplers: effect of staple height, buttress, and overlap on staple line failure
2008, Surgery for Obesity and Related Diseases
Citation Excerpt :
This observation is in agreement with several studies that have compared plain staple lines with reinforced ones. Animal studies have shown that reinforcement of the staple line with either bovine pericardium [16] or porcine small intestinal submucosa [17,18] increases the burst pressure of the staple lines in the bowel or stomach. However, buttressing can interfere with visualization and repeated staple fires.
Few studies have been designed to assess the performance of surgical staplers. In this study, we analyzed the effect of staple height, buttressing, and overlapping of staple lines on staple line failure.
Staple lines created on fresh porcine small bowel segments ex vivo were tested for leak pressure by insufflating air into the bowel under water and recording pressure at failure. Three separate experiments were done and included staple height (white, 2.5 mm, n = 16; blue, 3.5 mm, n = 16; green, 4.1 mm, n = 16; one half of them buttressed); the absence (n = 12) or presence (n = 12) of an overlap in 3.5-mm staple lines; and the absence (n = 14) or presence (n = 11) of buttresses in 3.5-mm overlapping staple lines. Data are reported in median values and ranges; nonparametric tests were used for data analysis.
In the porcine small bowel, leak pressure was related to staple height; green loads had the worst profile (35 mm Hg, range 19–105) compared with the blue (79 mm Hg, range 9–177), and white (108 mm Hg, range 28–280) loads (P = .006). Buttressing uniformly improved leak pressure for all staple loads (P <.0001). No significant difference was found between lines with overlapping (59 mm Hg, range 32–121) and those without (42 mm Hg, range 22–75; P = .162). Buttressing also improved the leak pressure of overlapping staple lines from 65 mm Hg (range 47–121) to 93 mm Hg (range 75–187; P = .0014).
Great variability was found in the leak pressures among the different applications of the same stapler. Staple height is an important determinant of leak pressure. The presence of an overlap did not affect leak pressure; in fact, a trend toward improvement was seen with overlapping staple lines. Buttressing improved all types of staple lines.

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Original articleStaple line reinforcement with new biomaterial increased burst strength pressure: an animal study

Abstract

Background

Methods

Results

Conclusion

Section snippets

Methods

Results

Discussion

Conclusion

J Am Col Surg

J Surg Res

Surg Clin North Am

Complications of the laparoscopic Roux-en-Y gastric bypass1,040 patients—what have we learned?

Obes Surg

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

Ann Surg

Laparoscopic Roux-en-Y gastric bypass—500 patientstechnique and results with 3–60 month follow-up

Obes Surg

Roux-en-Y gastric bypass leak complications

Arch Surg

Original article
Staple line reinforcement with new biomaterial increased burst strength pressure: an animal study