Decreasing anastomotic and staple line leaks after laparoscopic Roux-en-Y gastric bypass

Background   Anastomotic and staple line leaks (ASL) occur after laparoscopic Roux-en-Y gastric bypass (LRYGB) with a reported incidence as high as 6%. Leaks are the second most common cause of post-LRYGB mortality after pulmonary embolism, and can be associated with significant morbidity. Prevention and early detection may limit both morbidity and mortality. Methods   A retrospective analysis of prospectively collected data was performed on all LRYGBs performed in a community hospital by a single surgeon from August 2001 to December 2005. All operations were performed using a linear-stapled anastomosis with buttressing material, handsewn otomy closures, stay sutures, intraoperative leak testing, and fibrin sealant. Results   760 patients underwent LRYGB during the study period. Eighty-nine percent (n = 674) were female and 11% (n = 86) were male. Mean body mass index (BMI) was 50 kg/m² (range 36–83 kg/m²). Mean age was 40 years (range 17–72 years). Two patients developed three gastric pouch staple line leaks (0.4%). There were no mortalities. Conclusion   Operative technique, including appropriate staple sizing, staple line reinforcement, handsewn otomy closures, placement of stay sutures, intraoperative leak testing, and placement of fibrin sealant contributed to a lower than expected incidence of ASL after LRYGB in this series.     

Comparison of permanent and nonpermanent staple line buttressing materials for linear gastric staple lines during laparoscopic Roux-en-Y gastric bypass

BackgroundSeveral 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.MethodsFrom 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.ResultsThe 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).ConclusionNeither 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.     

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

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.     

Effect of circular staple line buttressing material on gastrojejunostomy failure in laparoscopic Roux-en-Y gastric bypass

BackgroundTo determine the effect of bovine pericardium strip (BPS) reinforcement of the circular stapler on the gastrojejunostomy leak rates and staple line failure after laparoscopic Roux-en-Y gastric bypass (LRYGB) at a university hospital in the United States. Gastrojejunostomy leak after LRYGB is a devastating complication. Various techniques, including buttressing the gastrojejunostomy staple line with biomaterial, have been used in an effort to minimize leaks.MethodsA total of 350 consecutive patients underwent LRYGB without staple line buttressing. After this initial experience, BPS reinforcement of the gastrojejunostomy was conducted in 81 consecutive patients. BPS reinforcement was not used for the final 69 consecutive patients in this 500 patient series. Circular staple line failures (intraoperative immediate and complete failure of the anastomosis) and leaks were evaluated retrospectively.ResultsThree leaks (and no intraoperative staple line failures) occurred in 419 patients without BPS buttressing, all in the first 100 cases of our experience, and 3 leaks and an anastomotic staple line failure occurred in the 81 patients with BPS buttressing (.7% versus 4.9%, P = .02). The body mass index and other potential leak risk factors did not differ between the 2 groups.ConclusionIn our experience, buttressing of the circular staple line with BPS during LRYGB was associated with an increased staple line adverse event rate. BPS buttressing of the gastrointestinal circular staple lines should be used with caution.     

Glycolide copolymer staple-line reinforcement reduces staple site bleeding during laparoscopic gastric bypass: a prospective randomized trial

HYPOTHESIS: The use of staple-line reinforcement sleeves during laparoscopic gastric bypass reduces staple-line bleeding, which may translate into a reduction in the rate of gastrointestinal hemorrhage. DESIGN: Prospective randomized trial. SETTING: University hospital. PATIENTS AND INTERVENTIONS: Thirty-four patients undergoing laparoscopic gastric bypass were randomly assigned to receive either no reinforcement (control group, n = 17) or reinforcement of the staple line with glycolic copolymer sleeves (treatment group, n = 17). MAIN OUTCOME MEASURES: Demographic data, the number of stapler loads used, the number of staple-line bleeding sites, the amount of blood loss, the length of time required to obtain hemostasis of the staple lines, operative time, intraoperative and postoperative complications, and serial hemoglobin levels. RESULTS: The mean number of stapler loads used was similar between groups. The mean number of staple-line bleeding sites was significantly fewer in the treatment group for division of gastric tissue (0.4 vs 2.5 bleeding sites), jejunal tissue (0.1 vs 0.6 bleeding site), and mesenteric tissue (0 vs 0.8 bleeding site). The mean blood loss was lower in the treatment group (84 vs 129 mL). Staple misfire occurred in 1 (0.7%) of 143 stapler loads used in the treatment group compared with 0 (0%) of 138 stapler loads used in the control group. The time to obtain staple-line hemostasis was shorter in the treatment group (1.2 vs 10.1 minutes). The total operative time was similar between groups. There was no mortality or postoperative leaks. One patient in the control group had postoperative gastrointestinal hemorrhage requiring blood transfusion and reoperation. There was no significant difference in the mean hemoglobin level between groups on the first postoperative day. CONCLUSIONS: The use of glycolide copolymer staple-line reinforcement sleeves in patients undergoing laparoscopic gastric bypass is safe and significantly reduces staple-line bleeding sites and may reduce the incidence of gastrointestinal hemorrhage.     

Functional assessment of a new staple line reinforcement in lung resection

BACKGROUND: A major complication of lung resection is prolonged leaking at the staple line. Staple-line reinforcement is performed routinely during these procedures using bovine pericardium (peri-strips) and expanded polytetrafluorethylene. Both materials have been shown previously to increase staple-line durability and reduce the overall incidence of prolonged air leaking after lung resection, specifically in lung volume-reduction surgery. Small intestinal submucosa (SIS) has had many applications in human tissues consequent to its absorption and healing profile, which are well documented in human and animal models. However, it had not been studied in reinforcement of pulmonary staple lines. MATERIALS AND METHODS: We hypothesized that SIS reinforcement of staple lines in healthy lung tissue would increase durability, as determined by leak rates at increased airway pressures as compared to nonreinforced staple lines. Eight healthy juvenile Yorkshire-cross pigs were subjected to bilateral apical lung resections; one side was reinforced with SIS. The lungs were then inflated to sequentially increase intrabronchial pressures (5-75 cm H2O) for 60-second intervals while the chest was filled with saline under direct visualization monitoring for air leak. RESULTS: Staple lines reinforced with porcine small intestinal submucosa had significantly better durability as determined by Kaplan-Meier survival calculations with respect to leak rate as a function of pressure. CONCLUSION: Reinforcement of staple lines with SIS allows pulmonary staple lines to tolerate significantly higher intrabronchial pressures without demonstrating air leak at the staple line.     

Clinical results using bioabsorbable staple line reinforcement for circular staplers

Although linear surgical staple line reinforcement has been shown to increase anastomotic tensile strength in animal models and reduce the incidence of staple line bleeding and anastomotic leaks in colorectal surgery, the benefits of staple line reinforcement on circular stapled anastomoses in bariatric surgery remain unreported in the literature. The purpose if this study was to compare the incidence of anastomotic bleeding, leak, and stricture in patients undergoing laparoscopic gastric bypass with circular staple line reinforcements with those with no circular staple line reinforcements. Since May 2006, 138 consecutive patients (Group B) have undergone laparoscopic Roux-en-Y divided gastric bypass with a 25-mm circular stapled gastrojejunal anastomosis using GORE SEAMGUARD bioabsorbable circular staple line reinforcement (CBSG) with a mean follow up of 9 months. The incidence of anastomotic bleeding, leak, and stricture was compared with 255 similar patients (Group A) who underwent surgery before May 2006 without gastrojejunal reinforcement with a mean follow up of 22 months. The rates of anastomotic bleeding, leak, and stricture for Group B versus Group A were 0.7 per cent versus 1.1 per cent (P = 0.64); 0.7 per cent versus 1.9 per cent (P = 0.34); and 0.7 per cent versus 9.3 per cent (P = 0.0005), respectively. The use of CBSG reduced the incidence of anastomotic stricture by 93 per cent and the incidence of a composite end point of all anastomotic complications by 85 per cent. Our results indicate that the use of circular staple line reinforcement at the gastrojejunal anastomosis in patients undergoing laparoscopic gastric bypass significantly decreases the incidence of anastomotic stricture and a composite end point of all anastomotic complications. On this basis, strong consideration should be given to the routine use of CBSG staple line reinforcement in patients undergoing laparoscopic divided gastric bypass with a circular stapled gastrojejunal anastomosis.     

Evaluation of bioabsorbable seamguard for staple line reinforcement in stapled rectal anastomoses

Introduction. The concept of staple line reinforcement is a growing area of interest. This study evaluated the feasibility and effect of using bioabsorbable Seamguard (BSG) to bolster end-to-end stapled rectal anastomoses in a porcine model. Methods. Eleven female 45-kg Yucatan domestic pigs were used. Each animal served as its own control by creating a BSG and nonreinforced anastomosis using a 29-mm end-to-end anastomotic stapling device. Reinforced anastomoses were randomized to proximal and distal positions along the rectum. Each staple line reinforcement agent consisted of adding BSG to the stapling device according to the manufacturer's instructions. Barium enemas were then performed and the 2 anastomotic sites harvested. Each anastomosis underwent burst testing. The internal diameter of each anastomosis was measured and underwent pathologic review. Results. Bolstered anastomoses offered no strength advantage as burst pressures were no different as compared with unbolstered anastomoses. There was also no difference in anastomotic internal or external diameters. Only 1 stapled anastomosis burst during testing and none in the bolstered group. On histological analysis, there was a significant increase in inflammatory infiltrate in the bolstered group as compared with the stapled group (P = .041), with a higher incidence of lymphocytes (P = .047) and giant cells (P = .037). There was no difference in mucosal loss at the anastomotic site, neovascularization, fibroblast presence, extent of fibrosis, muscle layer disruption, percentage of anastomosis replaced by collagen, and elastin deposition. Conclusions. The routine use of BSG bolsters in stapled rectal anastomoses is safe and results in equivalent anastomotic strength as traditional stapled anastomoses.     

Shorter circular staple is height associated with lower anastomotic stricture rate in laparoscopic gastric bypass

BackgroundAnastomotic stenosis, leak, and hemorrhage are common stapler-related complications of laparoscopic Roux-en-Y gastric bypass. In May 2007, we transitioned from a 25-mm diameter, 4.8-mm-height circular stapler to a 25-mm, 3.5-mm-height circular stapler. We hypothesized that the staple height would be associated with a decreased incidence of perioperative complications.MethodsThe records of 360 consecutive patients who had undergone laparoscopic Roux-en-Y gastric bypass from May 1, 2006 to March 31, 2008 were retrospectively abstracted. The National Surgical Quality Improvement Project and Michigan Bariatric Surgery Collaborative databases were used to collect the patient demographics and track complications of laparoscopic Roux-en-Y gastric bypass. Data were collected on the rates of anastomotic stenosis requiring dilation of the gastrojejunostomy, anastomotic leak, hemorrhage requiring transfusion, and wound infection. Patients with a 4.8-mm staple height gastrojejunostomy were compared with those with a 3.5-mm staple height gastrojejunostomy for differences in complications.ResultsThe groups were similar with respect to age, gender, body mass index, hypertension, hyperlipidemia, diabetes, sleep apnea, and surgery duration. In the 4.8- and 3.5-mm staple height groups, 15% and 6.1% required gastrojejunal dilation, respectively (P = .01). A trend was seen toward a decrease in postoperative hemorrhage (5% versus 2.8%) with the shorter staple height. No anastomotic leaks occurred, and the incidence of wound infection (1.7% versus 2.2%) was similar between the 2 groups.ConclusionIn the present study, the use of a 25-mm, 3.5-mm staple height circular stapler was associated with a decreased rate of anastomotic stenosis.     

Use of staple-line reinforcement in laparoscopic gastric bypass surgery: a meta-analysis

Objective  

This article was designed to systematically analyze the prospective, randomized, controlled trials on the effectiveness of staple-line reinforcement (SLR) in patients undergoing laparoscopic gastric bypass (LGBP) surgery.     

Reinforced staple line in severely emphysematous lungs

In severely emphysematous or otherwise destroyed lung parenchyma, staples often cut through, which causes prolonged postoperative air leakage. A mechanical suture line reinforced by a polydioxanone ribbon is a simple, safe, and effective method for closure of air leaks, resection, or biopsy in such cases.     

Effect of staple height on gastrojejunostomy during laparoscopic gastric bypass: a multicenter prospective randomized trial

BackgroundGastrointestinal (GI) bleeding and anastomotic stricture are frequent complications associated with the construction of the gastrojejunostomy during laparoscopic gastric bypass. Staplers with shorter staple height can reduce the rate of postoperative GI hemorrhage. The aim of the present study was to assess the outcomes of patients who had undergone gastric bypass with construction of the gastrojejunostomy using a 25-mm circular stapler with a 3.5- versus 4.8-mm staple height.MethodsFrom January 2007 to February 2009, 357 patients underwent laparoscopic gastric bypass using a circular stapler for construction of the gastrojejunostomy were randomly assigned to either the 3.5-mm (n = 180) or 4.8-mm (n = 177) group. Two patients randomized to the 4.8-mm group did not undergo the operative procedure and were excluded from the analysis. The primary outcome measures included the rate of GI hemorrhage, anastomotic stricture, and wound infection.ResultsThe 2 groups were similar with regard to the demographics and baseline body mass index (47 versus 48 kg/m²). The operative time, blood loss, and postoperative hematocrit on day 2 were similar between the 2 groups. No significant differences were seen in the overall rate of intraoperative GI bleeding or postoperative GI bleeding from all sources (3.3% for 3.5 mm versus 6.3% for 4.8 mm, P >.05); however, a trend was seen toward a lower rate of postoperative GI bleeding from the gastric pouch or gastrojejunostomy (.5% for 3.5 mm versus 3.4% for 4.8 mm, P = .06). The rate of anastomotic stricture was significantly lower in the 3.5-mm group (3.9% versus 16.0%, P <.01). No significant differences were seen in rate of wound infection between the 2 groups. Other morbidities for the entire study cohort included leaks (1.1%), pulmonary embolism (.6%), gastrointestinal obstruction (1.4%), and reoperation (3.4%). The overall in-hospital mortality rate was .3%, and the 30-day mortality rate was .8%.ConclusionsIn the present prospective, randomized trial, using a circular stapler with a shorter staple height (3.5 mm) during construction of the gastrojejunostomy, significantly reduced the rate of postoperative anastomotic stricture, with a trend toward a lower rate of GI bleeding from the gastrojejunostomy.     

Experimental evaluation of staple lines in gastric surgery

This study was designed to evaluate the bursting pressure, tensile strength, and healing of staple lines in the dog stomach. Pavlov pouches were created in 30 dogs using a single, double, or triple application of a stapler loaded with 4.8-mm staples. Staple lines were assessed immediately in half of the animals and after 21 days in the remaining animals. Acutely, reinforcing a single staple line with a second or third application of the stapler resulted in an anastomosis more resistant to leakage and disruption. Satisfactory healing occurred by 21 days and contributed to staple line strength in the pouches using a single and double application of the stapler. The orientation of collagen deposition in the anastomosis was related to the number of staples used. The degree of collagen deposition across the muscularis mucosa correlated with the healed staple line strength. Although healing occurred when a triple application of the stapler was utilized, the orientation of the fibroconnective tissue was parallel to the anastomosis and did not contribute to staple line integrity.     

The influence of staple height on postoperative complication rates after laparoscopic gastric bypass surgery using linear staplers

BackgroundThe use of circular staplers with a low staple height is associated with a lower risk for complication when used to construct the gastroenterostomy in laparoscopic gastric bypass surgery. The influence of staple height on outcome when using linear staplers has not been studied.ObjectivesTo investigate the influence of staple height when constructing the gastric pouch and gastroenterostomy using a linear stapler in laparoscopic gastric bypass surgery.SettingNationwide, Sweden.MethodsA retrospective, register-based cohort study, including all primary laparoscopic gastric bypass surgical procedures in Sweden registered in the Scandinavian Obesity Surgery Registry from January 2010 until January 2017, where linear staplers were used to construct the gastric pouch and the gastroenterostomy. Low stapler heights (closed height ≤1.0 mm) were compared with higher stapler heights (closed height ≥1.5 mm). The main outcome was postoperative complication within 30 days of surgery.ResultsWithin the study period, 27,975 patients were identified from the Scandinavian Obesity Surgery Registry. A closed staple height ≥1.5 mm was associated with higher risk for postoperative complication within 30 days of surgery compared with lower staple height. The risk was greater when used to construct the gastric pouch (adjusted odd ratio 1.30, 95% confidence interval 1.17–1.44, P < .001) as well as when constructing the gastroenterostomy (adjusted odd ratio 1.32, 95% confidence interval 1.20–1.45, P < .001).ConclusionThe use of low staple height for construction of the gastric pouch and gastroenterostomy in laparoscopic gastric bypass surgery was associated with lower complication rates.     

Stapled haemorrhoidectomy: bothersome staple line bleeding

BACKGROUND: The stapled haemorrhoidectomy procedure has been popularized as a painless and effective treatment for prolapsing haemorrhoidal disease. We have noted that staple line bleeding is a contributory factor to postoperative morbidity. METHODS: This was a retrospective analysis of the clinical records of consecutive stapled haemorrhoidectomy procedures performed in patients over a 1-year period. The outpatient, operative and inpatient records were reviewed. We assessed the incidence of intraoperative staple line bleeding, its management and early postoperative outcomes in our patients undergoing stapled haemorrhoidectomy. RESULTS: From March 2000 to March 2001, 39 stapled haemorrhoidectomy procedures were performed. Intraoperative staple line bleeding was recorded in 17 patients (44%) and suture reinforcement of this staple line was required in 12 (31%). Nine patients (23%) were admitted for postoperative per rectal bleeding, four of whom required surgical haemostasis of bleeding points along the staple line. Delayed secondary haemorrhage was seen in one patient. The incidence of postoperative bleeding in patients with noted staple line bleeding was 35%, compared with 14% in those without evidence of bleeding. CONCLUSION: Staple line bleeding is a technical difficulty and complication associated with stapled haemorrhoidectomy. It should be managed with meticulous haemostatic suture placement in order to avoid postoperative bleeding and the morbidity of re-operation for haemostasis.     

Comparison of hemostatic properties between collagen and synthetic buttress materials used in staple line reinforcement in a swine splenic hemorrhage model

Introduction  

The use of staplers in gastrointestinal surgery is widespread, especially in advanced laparoscopic procedures. Staple line reinforcement with a buttress reduces bleeding and associated complications through a combination of factors. The intrinsic hemostatic properties of buttress materials have not been examined. This study examined the intrinsic hemostatic properties of two different types of material used in buttressing in an accepted hemostasis model that does not involve stapling or its effects by compression.     

Collagen matrix in spinal cord injury

The fibrous scar that develops after central nervous system (CNS) injury is considered a major impediment for axonal regeneration. It consists of a dense collagen IV meshwork, which serves as a binding matrix for numerous other extracellular matrix components and inhibitory molecules like proteoglycans and semaphorins, but also growth-promoting factors. Inhibition of collagen matrix formation in brain and spinal cord lesions leads to axonal regeneration and functional recovery, although collagen IV per se is not inhibitory for axonal outgrowth. This review focuses on the molecular properties of the collagen IV matrix and its interactions with various molecules that are expressed after CNS lesion. Moreover, studies on collagen expression and matrix formation after injury of regenerating versus non-regenerating nervous systems are reviewed. Major differences in collagen deposition in the CNS and the peripheral nervous system (PNS) and differences in specific cell responses to extracellular matrix deposition in the lesion area are discussed. Therapeutic treatments aiming at suppression of fibrous scarring have been shown to promote axon regeneration in various lesion paradigms of the mammalian CNS.