- Email: [email protected]
Effect of circular staple line buttressing material on gastrojejunostomy failure in laparoscopic Roux-en-Y gastric bypass
Surgery for Obesity and Related Diseases 6 (2010) 64 – 67
Original article
Effect of circular staple line buttressing material on gastrojejunostomy failure in laparoscopic Roux-en-Y gastric bypass Anna Ibele, M.D., Michael Garren, M.D., Jon Gould, M.D.* University of Wisconsin School of Medicine and Public Health and UW Health Bariatric Surgery Program Received April 7, 2009; revised April 10, 2009; accepted May 13, 2009
Abstract
Background: To 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. Methods: A 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. Results: Three 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. Conclusion: In 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. (Surg Obes Relat Dis 2010;6:64 – 67.) © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Gastrojejunostomy leak; Bovine pericardium; Staple line buttressing
Gastrojejunostomy leak after laparoscopic Roux-en-Y gastric bypass (LRYGB) is a devastating complication [1–3]. Although several patient-related risk factors for leak, including a high body mass index, have been delineated, technical factors also play a role. Gastrojejunostomy leak is known to occur more commonly early in a bariatric surgeon’s experience [4]. Staple line buttressing technology was introduced in the 1990s to decrease air leaks during pulmonary resection. Subsequent testing in animal models demonstrated that stapled gastrointestinal anastomosis buttressed with bioprosthetic materials were subject to greater burst pressures than nonbuttressed anastomoses [5–7]. RePresented in part at the 2009 Association of Academic Surgery Congress, Fort Myers, Florida *Reprint requests: Jon C. Gould, MD, 600 Highland Avenue, H4/726 Clinical Science Center, Madison, WI 53792. E-mail: [email protected]
cently published clinical series have suggested that the use of staple line buttressing material during LRYGB has the potential to decrease the rates of anastomotic leakage and staple line bleeding [8,9]. Much of the clinical data regarding buttressed gastrojejunostomy leak rates has been for linear staple lines. Few studies have examined the effect of buttressing on the leak rates of circular stapled gastrojejunostomies in clinical practice. We reviewed our clinical series of LRYGB with circular stapled gastrojejunostomy to determine whether an association exists between bovine pericardial strip (BPS) reinforcement and the occurrence of leak or anastomotic failure.
Methods From July 2002 to April of 2008, 500 consecutive patients underwent LRYGB performed by the same 2 surgeons
1550-7289/10/$ – see front matter © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2009.05.006
A. Ibele et al. / Surgery for Obesity and Related Diseases 6 (2010) 64 – 67 Table 1 Patient characteristics BPS
Age (yr)
Women (%)
Preoperative BMI (kg/m2)
Leak (%)
Yes (n ⫽ 81) No (n ⫽ 419) P value
47 44.4 .03
81 82
50.5 49.7 .43
4.9 (n ⫽ 4) .7 (n ⫽ 3) .02
.99
BPS ⫽ bovine pericardium strip; BMI ⫽ body mass index.
in a bariatric surgery program. In our initial experience, the gastrojejunostomy was created using a nonbuttressed circular stapler. After 350 cases, we began to incorporate nonabsorbable buttressing material (Peri-Strips Dry with Veritas Collagen Matrix, Synovis Surgical Innovations, St. Paul, MN) on each side of the circular stapler. This was done for 81 consecutive cases. In the most recent portion of our series (69 patients), we abandoned the routine use of BPS material in the circular stapled gastrojejunostomy. The incidence of gastrojejunostomy leak and technical failure was compared between the buttressed and nonbuttressed groups. Both clinically significant postoperative and major intraoperative leaks (complete and immediate anastomotic staple line failure) were assessed. Our technique has been previously described in detail [9]. We constructed the gastrojejunostomy using a circular stapler (Ethicon, Somerville, NJ). The stapler anvil was placed transgastrically through a greater curve gastrotomy. The Roux limb was antegastric and antecolic. A 21-mm stapler was used for the first 150 cases, and a 25-mm circular stapler has been used for all subsequent cases. For the first 100 cases, the gastrojejunostomy was selectively oversewn in patients with a body mass index ⬎50 kg/m2. We subsequently adopted a routine of oversewing all gastrojejunostomies with interrupted 2-0 Vicryl sutures, regardless of the patient-related factors. For cases using BPS to reinforce the gastrojejunostomy, the 25-mm cartridges were applied to each end of the 25-mm circular stapler using PSD Gel (Synovis Surgical Innovations) in the manner described by the manufacturer. All other technical steps of LRYGB in the patients receiving BPS buttressing material were identical to those for patients before and after this segment of the case series who did not receive BPS buttressing. An intraoperative leak test was performed in all cases using an orogastric tube and the forceful insufflation of air through the gastrojejunostomy. A patient was considered to have experienced gastrojejunostomy failure in either of 2 possible scenarios. The first was the intraoperative and complete disruption of the gastrojejunostomy anastomosis. This is distinctly different from a positive leak test and involves the actual physical separation of the Roux limb from the gastric pouch after the circular stapler has been fired. This event was considered a leak, because this was a major intraoperative event that required significant additional operative time and effort to
65
correct, and because it represented a major technical failure that put the patient at increased risk of morbidity and mortality. A clinical leak was considered to have occurred when a patient, in the perioperative period, developed sepsis and peritonitis, prompting diagnostic laparoscopy at which a leaking gastrojejunostomy was identified. The preoperative variables were compared between the 2 groups using the Wilcoxon rank sum test. The leak rates were compared using Fisher’s exact test. P ⬍.05 was considered statistically significant. Our institutional review board approved the present study. Results A total of 350 consecutive patients underwent LRYGB without circular staple line buttressing of the gastrojejunostomy during a 4-year period. A subsequent group of 81 consecutive patients underwent LRYGB with BPS buttressing of the gastrojejunostomy within an 18-month period. BPS buttressing of the gastrojejunostomy was subsequently abandoned for an additional 69 patients who underwent LRYGB during the next 12 months. Patients who received BPS buttressing were slightly younger than those who did not. No difference was found in the body mass index or gender between the BPS buttressed and nonbuttressed groups (Table 1). Of the 81 patients in the BPS group, 4 experienced gastrojejunostomy technical failures (1 intraoperative anastomotic disruption and 3 postoperative clinical leaks requiring reoperation). In the patients undergoing LRYBP before our experience with BPS, 3 leaks occurred. All 3 of these leaks were perioperative clinical leaks, and all occurred in our first 100 cases. For ⬎42 consecutive months, no patient developed a leak in our initial nonbuttressed experience before our first leak in the BPS buttressed group. In the 69 cases after the end of our BPS experience, no additional leaks occurred. The patient characteristics were similar in the BPS-reinforced patients who experienced a leak and those who did not (Table 2). Discussion Leakage at the site of the gastrojejunostomy is a serious complication of LRYGB that can result in considerable morbidity and mortality. The incidence of leak has been reported to be anywhere from ⬍1% to ⬎5% [1,2,10]. A variety of patient and technical factors have been found to Table 2 Demographics in BPS-buttressed patients with and without leak Leak
Age (yr)
Women (%)
Preoperative BMI (kg/m2)
No (n ⫽ 77) Yes (n ⫽ 4) P value
47 52 .63
79 75 1.0
50.6 48.4 .59
Abbreviations as in Table 1.
66
A. Ibele et al. / Surgery for Obesity and Related Diseases 6 (2010) 64 – 67
increase the risk of anastomotic leak. The increased leak rates have been associated with patient age, male gender, and body mass index ⬎50 kg/m2 at surgery [9,11–13]. Technical factors such as staple line misfire, tissue ischemia, and tension on the Roux limb can also increase the risk of a postoperative leak [14]. Several gastrojejunostomy construction techniques have been studied with the goal of decreasing the likelihood of anastomotic leak owing to technical failure. Oversewing of staple lines, application of tissue sealants, covering the staple lines with omentum, and buttressing the staple lines with absorbable polymers or bovine pericardium have all been used, with varying results [5,15–17]. Most animal studies evaluating staple line buttressing in gastrointestinal stapled anastomosis have used the “burst pressure” as a marker of staple line security. Most published studies have evaluated linear staple lines, not the circular staple lines used in our clinical gastric bypass series [6]. The benefits of buttressing material in increasing the “leak pressure” in linear staple lines has also been demonstrated for various staple heights [7]. Whether the “burst pressure” or “leak pressure” or any other contrived measure of staple line integrity actually relates to the clinical risk of leak has not been demonstrated. In the perioperative clinical setting, distension and increased staple line pressures are rarely observed in patients with a leak. It is likely that tension, ischemia, poorly formed stapling, or poor tissue integrity have much more to do with the mechanism of leak than do distension and pressure. Clinical series evaluating the use of staple line buttressing in bariatric surgery have focused on several outcomes. Data have suggested that the use of buttressing material can minimize staple line bleeding events [18 –20]. Gastrojejunostomy stenosis rates can also be decreased in a patient with a buttressed anastomosis [21]. These potential benefits, in addition to the potential to minimize leaks, led to our decision to add BPS buttressing to our circular stapled gastrojejunostomy in LRYGB. The clinical data regarding leak rates with buttressed stapled gastrojejunostomy in LRYGB have been equivocal. Angrisani et al. [18] prospectively evaluated a series of patients who were randomly allocated to LRYGB with or without linear staple line buttressing with BPS. In their series, the intraoperative methylene blue leak test was positive in 12.5% of patients without buttressing (P ⬍.001). A difference in the clinical postoperative leak rate was not observed in this series. Jones et al. [21] evaluated the effect of an absorbable copolymer glycoside and trimethylene (Seamguard, Gore Medical, Flagstaff, AZ) on circular stapled gastrojejunostomy anastomotic complications. Although the gastrojejunostomy leak rates were not affected by the addition of the copolymer buttress, the stricture rates were dramatically decreased (9.3% versus .7%, P ⫽ .0005). Shikora et al. [8] retrospectively reviewed their series of 250 patients in whom BPS was used in the linear gastric staple line and
compared them with 100 previous patients (their initial experience with LRYGB) in whom BPS was not used. They had no leaks in their BPS buttressed group compared with a 2% leak rate in those without BPS [8]. The inclusion of the “learning curve” in 1 of the study groups and not the other might have accounted for these differences. The published “learning curve” for LRYGB could be as many as 100 cases [22]. We previously published data regarding our first 100 cases [9]. Of our nonbuttressed gastrojejunostomy leaks, 100% occurred in these initial 100 cases. None of our nearly 350 consecutive patients without buttressing experienced a leak in ⬎6 years. Shikora et al. [23] later compared their experience with BPS buttressing and absorbable copolymer buttressing of the linear stapled gastrojejunostomy in LRYGB. Of the 1,451 cases with buttressing material, essentially no leaks occurred in the BPS group and 4 leaks occurred in the absorbable copolymer group (P ⬍.01). We theorized that the increased leak rate we observed in our BPS group was related to staple dysfunction caused by the addition of the pericardial strips to the thickness of the tissue included in the anastomosis. The gastric wall thickness varies from patient to patient. The particular circular stapler we used to construct the gastrojejunostomy produced formed staples with a final closed staple height of 1.0 –2.5 mm, depending on how far into the “fire zone” the anvil was cranked toward the stapler itself. Bovine pericardium strips are not homogenous and can vary in thickness quite a bit from strip to strip. We believe that the variability related to all these factors could have resulted in a scenario in which too much tissue was compressed in the staples, resulting in early staple line failure. A number of events have been reported to the U.S. Food and Drug Administration in which BPS circular staple line buttressing material was used during gastric bypass surgery. A search of the Manufacturer and User Facility Device Experience Database (available from: www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfMAUDE/search.cfm) since 2005 (accessed April 7, 2009) revealed 8 reported immediate technical failures of the circular staple line in LRYGB cases using Peri-Strips Dry with Collagen Matrix (Synovis Surgical Innovations). An additional 3 cases in which a postoperative leak developed in similar cases were also reported in the same period. Although it is certainly impossible to attribute these leaks directly to the use of BPSs in the circular staple line, the number of reported intraoperative technical mishaps is a cause for concern. Conclusion In our experience, the use of BPS buttressing material in the circular stapled gastrojejunostomy for LRYGB was associated with an increased incidence of gastrojejunostomy technical complications. Ours is the only series to specifically examine the effect of BPS material on circular staple line leaks in clinical practice. We believe it is possible that
A. Ibele et al. / Surgery for Obesity and Related Diseases 6 (2010) 64 – 67
the animal and clinical data published examining the effect of buttressing material on gastrointestinal staple lines might not apply to this combination of the specific stapler and buttressing material we used. These findings have led us to abandon the routine use of BPS with our circular stapled gastrojejunostomy. Additional study is necessary to determine whether the association we observed is, in fact, real. We believe that the BPS buttressing material should be used with great caution in circular stapled gastrojejunostomy for LRYGB. Disclosures The authors claim no commercial associations that might be a conflict of interest in relation to this article. References [1] Marshall JS, Srivastava A, Gupta SK, Rossi TR, DeBord JR. Roux-en-Y gastric bypass leak complications. Arch Surg 2003;138:520 – 4. [2] DeMaria EJ, Sugerman HL, Kellum JM, Meador JG, Wolfe LG. Results of 281 consecutive total laparoscopic Roux-en-Y gastric bypasses to treat morbid obesity. Ann Surg 2002;235:640 –5. [3] Schauer PR, Gourash W, Ramanathan R, Luketich J. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg 2000;232:515–29. [4] Maher JW, Hawver LM, Pucci A, Wolfe LG, Meador JG, Kellum JM. Four hundred fifty consecutive laparoscopic Roux-en-Y gastric bypasses with no mortality and declining leak rates and lengths of stay in a bariatric training program. J Am Coll Surg 2008;206:940 – 4. [5] Downey DM, Harre JG, Dolan JP. Increased burst pressure in gastrointestinal staple-lines using reinforcement with a bioprosthetic material. Obes Surg 2005;15:1379 – 83. [6] Arnold W, Shikora SA. A comparison of burst pressure between buttressed versus non-buttressed staple-lines in an animal model. Obes Surg 2005;15:164 –71. [7] Mery CM, Shafi BM, Binyamin G, Morton JM, Gertner M. Profiling surgical staplers: effect of staple height, buttress, and overlap on staple line failure. Surg Obes Relat Dis 2008;4:416 –22. [8] Shikora SA, Kim JJ, Tarnoff ME. Reinforcing gastric staple-lines with bovine pericardial strips may decrease the likelihood of gastric leak after laparoscopic Roux-en-Y gastric bypass. Obes Surg 2003; 13:37– 44.
67
[9] Gould J, Garren MJ, Starling JR. Lessons learned from the first 100 cases in a new minimally invasive bariatric surgery program. Obes Surg 2004;14:618 –25. [10] Brolin R. Gastric bypass. Surg Clin North Am 2001;81:1077–95. [11] Flancbaum L, Belsley S. Factors affecting morbidity and mortality of Roux-en-Y gastric bypass for clinically severe obesity: an analysis of 1,000 consecutive open cases by a single surgeon. J Gastrointest Surg 2007;11:500 –7. [12] Fernandez AZ Jr, Demaria E, Tichansky DS, et al. Experience with over 3,000 open and laparoscopic bariatric procedures: multivariate analysis of factors related to leak and resultant mortality. Surg Endosc 2004;18:193–7. [13] Livingston E. Complications of bariatric surgery. Surg Clin North Am 2005;85:853– 68. [14] Gonzalez R, Nelson LG, Gallagher SF, Murr MM. Anastomotic leaks after laparoscopic gastric bypass. Obes Surg 2004;14:1299 –307. [15] de la Torre RA, Scott JS. Laparoscopic Roux-en-Y gastric bypass: a totally intra-abdominal approach—technique and preliminary report. Obes Surg 1999;9:492– 8. [16] Fobi MA, Lee H. The surgical technique of the Fobi-Pouch operation for obesity (the transected silastic vertical gastric bypass). Obes Surg 1998;8:283– 8. [17] Sapala JA, Wood MH, Schuhknecht MP. Anastomotic leak prophylaxis using a vapor-heated fibrin sealant: report on 738 gastric bypass patients. Obes Surg 2004;14:35– 42. [18] Angrisani L, Lorenzo M, Borrelli V, Ciannella M, Bassi UA. The use of bovine pericardial strips on linear stapler to reduce extraluminal bleeding during laparoscopic gastric bypass: prospective randomized clinical trial. Obes Surg 2004;14:1198 –202. [19] Nguyen NT, Longoria M, Welbourne S, Sabio A, Wilson SE. Glycoside copolymer staple-line reinforcement reduces staple site bleeding during laparoscopic gastric bypass. Arch Surg 2005;140:773– 8. [20] Saber AA, Scharf KR, Turk AZ, Elgamal MH, Martinez RL. Early experience with intraluminal reinforcement of stapled gastrojejunostomy during laparoscopic Roux-en-Y gastric bypass. Obes Surg 2008; 18:525–9. [21] Jones WB, Myers KM, Traxler LB, Bour ES. Clinical results using bioabsorbable staple line reinforcement for circular staplers. Am Surg 2008;74:462–7. [22] Schauer P, Ikramuddin S, Hamad G, Gourash W. The learning curve for laparoscopic Roux-en-Y gastric bypass is 100 cases. Surg Endosc 2003;17:212–5. [23] Shikora SA, Kim JJ, Tarnoff ME. Comparison of permanent and nonpermanent staple line buttressing materials for linear gastric staple lines during laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis 2008;4:729 –34.
Original article
Effect of circular staple line buttressing material on gastrojejunostomy failure in laparoscopic Roux-en-Y gastric bypass Anna Ibele, M.D., Michael Garren, M.D., Jon Gould, M.D.* University of Wisconsin School of Medicine and Public Health and UW Health Bariatric Surgery Program Received April 7, 2009; revised April 10, 2009; accepted May 13, 2009
Abstract
Background: To 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. Methods: A 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. Results: Three 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. Conclusion: In 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. (Surg Obes Relat Dis 2010;6:64 – 67.) © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Gastrojejunostomy leak; Bovine pericardium; Staple line buttressing
Gastrojejunostomy leak after laparoscopic Roux-en-Y gastric bypass (LRYGB) is a devastating complication [1–3]. Although several patient-related risk factors for leak, including a high body mass index, have been delineated, technical factors also play a role. Gastrojejunostomy leak is known to occur more commonly early in a bariatric surgeon’s experience [4]. Staple line buttressing technology was introduced in the 1990s to decrease air leaks during pulmonary resection. Subsequent testing in animal models demonstrated that stapled gastrointestinal anastomosis buttressed with bioprosthetic materials were subject to greater burst pressures than nonbuttressed anastomoses [5–7]. RePresented in part at the 2009 Association of Academic Surgery Congress, Fort Myers, Florida *Reprint requests: Jon C. Gould, MD, 600 Highland Avenue, H4/726 Clinical Science Center, Madison, WI 53792. E-mail: [email protected]
cently published clinical series have suggested that the use of staple line buttressing material during LRYGB has the potential to decrease the rates of anastomotic leakage and staple line bleeding [8,9]. Much of the clinical data regarding buttressed gastrojejunostomy leak rates has been for linear staple lines. Few studies have examined the effect of buttressing on the leak rates of circular stapled gastrojejunostomies in clinical practice. We reviewed our clinical series of LRYGB with circular stapled gastrojejunostomy to determine whether an association exists between bovine pericardial strip (BPS) reinforcement and the occurrence of leak or anastomotic failure.
Methods From July 2002 to April of 2008, 500 consecutive patients underwent LRYGB performed by the same 2 surgeons
1550-7289/10/$ – see front matter © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2009.05.006
A. Ibele et al. / Surgery for Obesity and Related Diseases 6 (2010) 64 – 67 Table 1 Patient characteristics BPS
Age (yr)
Women (%)
Preoperative BMI (kg/m2)
Leak (%)
Yes (n ⫽ 81) No (n ⫽ 419) P value
47 44.4 .03
81 82
50.5 49.7 .43
4.9 (n ⫽ 4) .7 (n ⫽ 3) .02
.99
BPS ⫽ bovine pericardium strip; BMI ⫽ body mass index.
in a bariatric surgery program. In our initial experience, the gastrojejunostomy was created using a nonbuttressed circular stapler. After 350 cases, we began to incorporate nonabsorbable buttressing material (Peri-Strips Dry with Veritas Collagen Matrix, Synovis Surgical Innovations, St. Paul, MN) on each side of the circular stapler. This was done for 81 consecutive cases. In the most recent portion of our series (69 patients), we abandoned the routine use of BPS material in the circular stapled gastrojejunostomy. The incidence of gastrojejunostomy leak and technical failure was compared between the buttressed and nonbuttressed groups. Both clinically significant postoperative and major intraoperative leaks (complete and immediate anastomotic staple line failure) were assessed. Our technique has been previously described in detail [9]. We constructed the gastrojejunostomy using a circular stapler (Ethicon, Somerville, NJ). The stapler anvil was placed transgastrically through a greater curve gastrotomy. The Roux limb was antegastric and antecolic. A 21-mm stapler was used for the first 150 cases, and a 25-mm circular stapler has been used for all subsequent cases. For the first 100 cases, the gastrojejunostomy was selectively oversewn in patients with a body mass index ⬎50 kg/m2. We subsequently adopted a routine of oversewing all gastrojejunostomies with interrupted 2-0 Vicryl sutures, regardless of the patient-related factors. For cases using BPS to reinforce the gastrojejunostomy, the 25-mm cartridges were applied to each end of the 25-mm circular stapler using PSD Gel (Synovis Surgical Innovations) in the manner described by the manufacturer. All other technical steps of LRYGB in the patients receiving BPS buttressing material were identical to those for patients before and after this segment of the case series who did not receive BPS buttressing. An intraoperative leak test was performed in all cases using an orogastric tube and the forceful insufflation of air through the gastrojejunostomy. A patient was considered to have experienced gastrojejunostomy failure in either of 2 possible scenarios. The first was the intraoperative and complete disruption of the gastrojejunostomy anastomosis. This is distinctly different from a positive leak test and involves the actual physical separation of the Roux limb from the gastric pouch after the circular stapler has been fired. This event was considered a leak, because this was a major intraoperative event that required significant additional operative time and effort to
65
correct, and because it represented a major technical failure that put the patient at increased risk of morbidity and mortality. A clinical leak was considered to have occurred when a patient, in the perioperative period, developed sepsis and peritonitis, prompting diagnostic laparoscopy at which a leaking gastrojejunostomy was identified. The preoperative variables were compared between the 2 groups using the Wilcoxon rank sum test. The leak rates were compared using Fisher’s exact test. P ⬍.05 was considered statistically significant. Our institutional review board approved the present study. Results A total of 350 consecutive patients underwent LRYGB without circular staple line buttressing of the gastrojejunostomy during a 4-year period. A subsequent group of 81 consecutive patients underwent LRYGB with BPS buttressing of the gastrojejunostomy within an 18-month period. BPS buttressing of the gastrojejunostomy was subsequently abandoned for an additional 69 patients who underwent LRYGB during the next 12 months. Patients who received BPS buttressing were slightly younger than those who did not. No difference was found in the body mass index or gender between the BPS buttressed and nonbuttressed groups (Table 1). Of the 81 patients in the BPS group, 4 experienced gastrojejunostomy technical failures (1 intraoperative anastomotic disruption and 3 postoperative clinical leaks requiring reoperation). In the patients undergoing LRYBP before our experience with BPS, 3 leaks occurred. All 3 of these leaks were perioperative clinical leaks, and all occurred in our first 100 cases. For ⬎42 consecutive months, no patient developed a leak in our initial nonbuttressed experience before our first leak in the BPS buttressed group. In the 69 cases after the end of our BPS experience, no additional leaks occurred. The patient characteristics were similar in the BPS-reinforced patients who experienced a leak and those who did not (Table 2). Discussion Leakage at the site of the gastrojejunostomy is a serious complication of LRYGB that can result in considerable morbidity and mortality. The incidence of leak has been reported to be anywhere from ⬍1% to ⬎5% [1,2,10]. A variety of patient and technical factors have been found to Table 2 Demographics in BPS-buttressed patients with and without leak Leak
Age (yr)
Women (%)
Preoperative BMI (kg/m2)
No (n ⫽ 77) Yes (n ⫽ 4) P value
47 52 .63
79 75 1.0
50.6 48.4 .59
Abbreviations as in Table 1.
66
A. Ibele et al. / Surgery for Obesity and Related Diseases 6 (2010) 64 – 67
increase the risk of anastomotic leak. The increased leak rates have been associated with patient age, male gender, and body mass index ⬎50 kg/m2 at surgery [9,11–13]. Technical factors such as staple line misfire, tissue ischemia, and tension on the Roux limb can also increase the risk of a postoperative leak [14]. Several gastrojejunostomy construction techniques have been studied with the goal of decreasing the likelihood of anastomotic leak owing to technical failure. Oversewing of staple lines, application of tissue sealants, covering the staple lines with omentum, and buttressing the staple lines with absorbable polymers or bovine pericardium have all been used, with varying results [5,15–17]. Most animal studies evaluating staple line buttressing in gastrointestinal stapled anastomosis have used the “burst pressure” as a marker of staple line security. Most published studies have evaluated linear staple lines, not the circular staple lines used in our clinical gastric bypass series [6]. The benefits of buttressing material in increasing the “leak pressure” in linear staple lines has also been demonstrated for various staple heights [7]. Whether the “burst pressure” or “leak pressure” or any other contrived measure of staple line integrity actually relates to the clinical risk of leak has not been demonstrated. In the perioperative clinical setting, distension and increased staple line pressures are rarely observed in patients with a leak. It is likely that tension, ischemia, poorly formed stapling, or poor tissue integrity have much more to do with the mechanism of leak than do distension and pressure. Clinical series evaluating the use of staple line buttressing in bariatric surgery have focused on several outcomes. Data have suggested that the use of buttressing material can minimize staple line bleeding events [18 –20]. Gastrojejunostomy stenosis rates can also be decreased in a patient with a buttressed anastomosis [21]. These potential benefits, in addition to the potential to minimize leaks, led to our decision to add BPS buttressing to our circular stapled gastrojejunostomy in LRYGB. The clinical data regarding leak rates with buttressed stapled gastrojejunostomy in LRYGB have been equivocal. Angrisani et al. [18] prospectively evaluated a series of patients who were randomly allocated to LRYGB with or without linear staple line buttressing with BPS. In their series, the intraoperative methylene blue leak test was positive in 12.5% of patients without buttressing (P ⬍.001). A difference in the clinical postoperative leak rate was not observed in this series. Jones et al. [21] evaluated the effect of an absorbable copolymer glycoside and trimethylene (Seamguard, Gore Medical, Flagstaff, AZ) on circular stapled gastrojejunostomy anastomotic complications. Although the gastrojejunostomy leak rates were not affected by the addition of the copolymer buttress, the stricture rates were dramatically decreased (9.3% versus .7%, P ⫽ .0005). Shikora et al. [8] retrospectively reviewed their series of 250 patients in whom BPS was used in the linear gastric staple line and
compared them with 100 previous patients (their initial experience with LRYGB) in whom BPS was not used. They had no leaks in their BPS buttressed group compared with a 2% leak rate in those without BPS [8]. The inclusion of the “learning curve” in 1 of the study groups and not the other might have accounted for these differences. The published “learning curve” for LRYGB could be as many as 100 cases [22]. We previously published data regarding our first 100 cases [9]. Of our nonbuttressed gastrojejunostomy leaks, 100% occurred in these initial 100 cases. None of our nearly 350 consecutive patients without buttressing experienced a leak in ⬎6 years. Shikora et al. [23] later compared their experience with BPS buttressing and absorbable copolymer buttressing of the linear stapled gastrojejunostomy in LRYGB. Of the 1,451 cases with buttressing material, essentially no leaks occurred in the BPS group and 4 leaks occurred in the absorbable copolymer group (P ⬍.01). We theorized that the increased leak rate we observed in our BPS group was related to staple dysfunction caused by the addition of the pericardial strips to the thickness of the tissue included in the anastomosis. The gastric wall thickness varies from patient to patient. The particular circular stapler we used to construct the gastrojejunostomy produced formed staples with a final closed staple height of 1.0 –2.5 mm, depending on how far into the “fire zone” the anvil was cranked toward the stapler itself. Bovine pericardium strips are not homogenous and can vary in thickness quite a bit from strip to strip. We believe that the variability related to all these factors could have resulted in a scenario in which too much tissue was compressed in the staples, resulting in early staple line failure. A number of events have been reported to the U.S. Food and Drug Administration in which BPS circular staple line buttressing material was used during gastric bypass surgery. A search of the Manufacturer and User Facility Device Experience Database (available from: www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfMAUDE/search.cfm) since 2005 (accessed April 7, 2009) revealed 8 reported immediate technical failures of the circular staple line in LRYGB cases using Peri-Strips Dry with Collagen Matrix (Synovis Surgical Innovations). An additional 3 cases in which a postoperative leak developed in similar cases were also reported in the same period. Although it is certainly impossible to attribute these leaks directly to the use of BPSs in the circular staple line, the number of reported intraoperative technical mishaps is a cause for concern. Conclusion In our experience, the use of BPS buttressing material in the circular stapled gastrojejunostomy for LRYGB was associated with an increased incidence of gastrojejunostomy technical complications. Ours is the only series to specifically examine the effect of BPS material on circular staple line leaks in clinical practice. We believe it is possible that
A. Ibele et al. / Surgery for Obesity and Related Diseases 6 (2010) 64 – 67
the animal and clinical data published examining the effect of buttressing material on gastrointestinal staple lines might not apply to this combination of the specific stapler and buttressing material we used. These findings have led us to abandon the routine use of BPS with our circular stapled gastrojejunostomy. Additional study is necessary to determine whether the association we observed is, in fact, real. We believe that the BPS buttressing material should be used with great caution in circular stapled gastrojejunostomy for LRYGB. Disclosures The authors claim no commercial associations that might be a conflict of interest in relation to this article. References [1] Marshall JS, Srivastava A, Gupta SK, Rossi TR, DeBord JR. Roux-en-Y gastric bypass leak complications. Arch Surg 2003;138:520 – 4. [2] DeMaria EJ, Sugerman HL, Kellum JM, Meador JG, Wolfe LG. Results of 281 consecutive total laparoscopic Roux-en-Y gastric bypasses to treat morbid obesity. Ann Surg 2002;235:640 –5. [3] Schauer PR, Gourash W, Ramanathan R, Luketich J. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg 2000;232:515–29. [4] Maher JW, Hawver LM, Pucci A, Wolfe LG, Meador JG, Kellum JM. Four hundred fifty consecutive laparoscopic Roux-en-Y gastric bypasses with no mortality and declining leak rates and lengths of stay in a bariatric training program. J Am Coll Surg 2008;206:940 – 4. [5] Downey DM, Harre JG, Dolan JP. Increased burst pressure in gastrointestinal staple-lines using reinforcement with a bioprosthetic material. Obes Surg 2005;15:1379 – 83. [6] Arnold W, Shikora SA. A comparison of burst pressure between buttressed versus non-buttressed staple-lines in an animal model. Obes Surg 2005;15:164 –71. [7] Mery CM, Shafi BM, Binyamin G, Morton JM, Gertner M. Profiling surgical staplers: effect of staple height, buttress, and overlap on staple line failure. Surg Obes Relat Dis 2008;4:416 –22. [8] Shikora SA, Kim JJ, Tarnoff ME. Reinforcing gastric staple-lines with bovine pericardial strips may decrease the likelihood of gastric leak after laparoscopic Roux-en-Y gastric bypass. Obes Surg 2003; 13:37– 44.
67
[9] Gould J, Garren MJ, Starling JR. Lessons learned from the first 100 cases in a new minimally invasive bariatric surgery program. Obes Surg 2004;14:618 –25. [10] Brolin R. Gastric bypass. Surg Clin North Am 2001;81:1077–95. [11] Flancbaum L, Belsley S. Factors affecting morbidity and mortality of Roux-en-Y gastric bypass for clinically severe obesity: an analysis of 1,000 consecutive open cases by a single surgeon. J Gastrointest Surg 2007;11:500 –7. [12] Fernandez AZ Jr, Demaria E, Tichansky DS, et al. Experience with over 3,000 open and laparoscopic bariatric procedures: multivariate analysis of factors related to leak and resultant mortality. Surg Endosc 2004;18:193–7. [13] Livingston E. Complications of bariatric surgery. Surg Clin North Am 2005;85:853– 68. [14] Gonzalez R, Nelson LG, Gallagher SF, Murr MM. Anastomotic leaks after laparoscopic gastric bypass. Obes Surg 2004;14:1299 –307. [15] de la Torre RA, Scott JS. Laparoscopic Roux-en-Y gastric bypass: a totally intra-abdominal approach—technique and preliminary report. Obes Surg 1999;9:492– 8. [16] Fobi MA, Lee H. The surgical technique of the Fobi-Pouch operation for obesity (the transected silastic vertical gastric bypass). Obes Surg 1998;8:283– 8. [17] Sapala JA, Wood MH, Schuhknecht MP. Anastomotic leak prophylaxis using a vapor-heated fibrin sealant: report on 738 gastric bypass patients. Obes Surg 2004;14:35– 42. [18] Angrisani L, Lorenzo M, Borrelli V, Ciannella M, Bassi UA. The use of bovine pericardial strips on linear stapler to reduce extraluminal bleeding during laparoscopic gastric bypass: prospective randomized clinical trial. Obes Surg 2004;14:1198 –202. [19] Nguyen NT, Longoria M, Welbourne S, Sabio A, Wilson SE. Glycoside copolymer staple-line reinforcement reduces staple site bleeding during laparoscopic gastric bypass. Arch Surg 2005;140:773– 8. [20] Saber AA, Scharf KR, Turk AZ, Elgamal MH, Martinez RL. Early experience with intraluminal reinforcement of stapled gastrojejunostomy during laparoscopic Roux-en-Y gastric bypass. Obes Surg 2008; 18:525–9. [21] Jones WB, Myers KM, Traxler LB, Bour ES. Clinical results using bioabsorbable staple line reinforcement for circular staplers. Am Surg 2008;74:462–7. [22] Schauer P, Ikramuddin S, Hamad G, Gourash W. The learning curve for laparoscopic Roux-en-Y gastric bypass is 100 cases. Surg Endosc 2003;17:212–5. [23] Shikora SA, Kim JJ, Tarnoff ME. Comparison of permanent and nonpermanent staple line buttressing materials for linear gastric staple lines during laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis 2008;4:729 –34.