Surgery for Obesity and Related Diseases ] (2015) 00–00
Original article
Gastrojejunostomy Technique and Anastomotic Complications in Laparoscopic Gastric Bypass Alex W. Lois, B.S., Matthew J. Frelich, M.S., Matthew I. Goldblatt, M.D., James R. Wallace, M.D., PhD, Jon C. Gould, M.D.* Medical College of Wisconsin, Department of Surgery, Milwaukee, Wisconsin Received August 3, 2014; accepted November 8, 2014
Abstract
Background: Various surgical techniques exist to create the gastrojejunostomy during laparoscopic Roux-en-Y gastric bypasses (LRYGB). A hand-sewn anastomosis (HSA) and circular-stapled anastomosis (CSA) are both common techniques. We hypothesized that the CSA was associated with a greater incidence of anastomotic complications. As a secondary aim, we sought to determine if weight loss varied by technique. Methods: This study is a retrospective review of patients who underwent primary LRYGB at the Medical College of Wisconsin from January 2010 to December 2011. Procedures were performed by one of 2 surgeons, each with a preferred gastrojejunostomy technique. Clinical information and patient outcomes were followed up to one year. Results: A total of 190 patients underwent LRYGB during the study interval. The majority of patients underwent HSA. Forty-one of 190 (21.6%) patients experienced one or more complications. Most complications were Clavien Classification Grade III and were experienced within 30 days of surgery in 3 (2.2%) HSA patients and 6 (10.9%) CSA patients (P ¼ .02). Anastomotic complications occurred more frequently with the CSA technique (marginal ulcer 5.5% CSA versus .7% HSA; P ¼ .04 and stenosis 16.4% CSA versus 3% HSA; P ¼ .01). There were no gastrojejunostomy leaks in this series. Operative time was significantly longer in HSA patients (204 minutes HSA versus 166 minutes CSA; P o .01), but length of hospital stay did not differ. Weight loss at 12 months was similar between techniques (69.4% percent excess BMI lost (EBMIL) HSA versus 76.6% EBMIL CSA; P ¼ .11). No patients were lost to follow-up at 30 days. Thirty-five patients (19%) were lost to follow-up by one year. Conclusion: The CSA technique of gastrojejunostomy in gastric bypass is associated with a higher rate of nonlife threatening anastomotic complications than the HSA technique. Operative times are significantly longer for HSA, but length of hospital stay (LOS) and long-term weight loss are equivalent. (Surg Obes Relat Dis 2015;]:00–00.) r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Gastrojejunostomy; Anastomosis; Hand-sewn; Circular-stapled; Complications
Background Presented as a Poster at the annual SAGES meeting, April 4, 2014, Salt Lake City, UT * Correspondence: Jon C. Gould, M.D. Medical College of Wisconsin, Department of Surgery, 9200 West Wisconsin Ave, Milwaukee, WI 53226, USA. Tel.: 414-805-5928. Fax: 414-454-0152. E-mail: [email protected]
Several different surgical techniques are commonly employed to create the gastrojejunostomy during laparoscopic Roux-en-Y gastric bypass surgery [1]. Depending upon their preference, surgeons may choose a hand-sewn anastomosis (HSA), circular-stapled anastomosis (CSA), or linear-stapled anastomosis (LSA). Complications among the
http://dx.doi.org/10.1016/j.soard.2014.11.029 1550-7289/r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.
A. W. Lois et al. / Surgery for Obesity and Related Diseases ] (2015) 00–00
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3 techniques may vary in incidence and can include gastrojejunostomy stenosis, marginal ulcer, and wound infections. These anastomotic techniques also differ in terms of technical difficulty and operative time [2,3]. Surgeons in our bariatric surgery program perform laparoscopic Roux-en-Y gastric bypass using both the HSA and CSA technique. We hypothesized that the CSA technique was associated with a greater incidence of anastomotic complications such as marginal ulcer and stenosis. As a secondary aim, we also sought to determine if weight loss outcomes varied by technique. Methods After Institutional Review Board approval, a retrospective review of prospectively collected data was undertaken to compare outcomes for patients undergoing laparoscopic gastric bypass with the HSA and CSA techniques over a 2year period (January 2010 to December 2011). All procedures were performed by one of 2 surgeons who each utilized different gastrojejunostomy construction techniques. Perioperative and postoperative outcomes to 12 months were reviewed. Weight loss was evaluated using 2 metrics, %EBMIL (percent excess BMI lost) and %EWL (percent excess weight loss), which were calculated according to the following formulas [4]: %EBMIL ¼
preoperative BMI – postoperative BMI 100 preoperative BMI – 25
and %EWL ¼
preoperative weight – postoperative weight 100 preoperative weight – ideal weight
Ideal weight was estimated using the middle value of the 1983 Metropolitan Life Insurance tables for median frame. When calculating the operative time and length of hospital stay (LOS), only laparoscopic gastric bypass procedures without concomitant procedures (such as incisional hernia repair and cholecystectomy) were included. Complications were graded by the intervention required according to the Clavien Classification System [5]. Briefly, Clavien grade I is deviation from postoperative course not requiring pharmacologic or surgical intervention; grade II requires pharmacologic intervention; grade III is an intervention requiring general anesthesia; grade IV results in organ system dysfunction; and grade V results in death. Patients with multiple complications resolved by a single intervention were counted as one complication (for example a patient with a marginal ulcer and gastrojejunostomy stenosis both resolved with endoscopic dilation). Stenosis was defined as a gastrojejunostomy diameter less than that of a therapeutic endoscope (11 mm) in a symptomatic patient (pain, dysphagia, vomiting). Gastrojejunostomy stenosis was diagnosed and treated with serial endoscopic balloon dilation. Anastomotic ulcers were diagnosed endoscopically.
They were treated with a 30-day regimen consisting of high dose acid suppression in conjunction with Carafate daily. For the hand-sewn anastomosis, a 2-layer hand-sewn technique with absorbable sutures was used to create the gastrojejunostomy around a 32French tube resulting in a 10mm diameter anastomosis. A 20 mL isolated gastric pouched was created following measurement of the Rouxlimb. The anastomosis was made in the inferior-lateral corner of the pouch staple line. A running 3-0 Vicryl suture with seromuscular bites was used for an outer layer of Lembert sutures and a running 3-0 Vicryl with full thickness bites was used for the inner layer of sutures. In the majority of patients undergoing LRYGB with the HSA technique, the Roux-limb was placed in the retrocolic, antegastric location. When this placement was not possible, an antecolic placement was used. The CSA technique involved the transgastric placement of a 25 mm circular stapler anvil. A 20 mL isolated gastric pouch was created once the anvil had been placed. As a result, the gastrojejunostomy was located on the anteriorinferior wall of the gastric pouch. Care was taken to ensure that the circular staple line and the pouch staple line did not cross. Oversewing of the gastrojejunostomy was not routinely performed unless the integrity of the staple line was in question. In these cases, Vicryl sutures were used. Leak tests were performed intraoperatively as a routine in all patients in this study. The Roux-limb was routinely placed in the antecolic, antegastric location for all CSA procedures. Statistical analysis of our data was conducted using VassarStats (Vassar College, Poughkeepsie, NY). Twotailed Fisher’s exact test was used to compare categorical data, and continuous data was compared using 2-tailed T tests. A P value o .05 was considered statistically significant. Results There were a total of 190 patients who underwent laparoscopic Roux-en Y gastric bypass during the study interval. Demographic characteristics did not differ significantly between study groups and are detailed in Table 1. The majority of patients underwent HSA. Of the 190 patients, 155 (81%) completed follow-up to at least 12 months. Follow-up at 30 days was 100% and follow-up at 6 months was 95%. The HSA technique was associated with a significantly longer operative time, but a similar LOS (Table 1). There was no significant difference in mean %EBMIL or %EWL between HSA and CSA at 12 months (Table 2). The overall morbidity rate was 21.6%, with 41 of the 190 patients experiencing at least one complication. Four patients experienced 2 or more complications. Complications are described in detail in [Table 2. Stenosis at the gastrojejunostomy and anastomotic ulcers were observed more frequently in CSA patients. Wound infections and reoperations occurred at a low rate overall, but were more common with the CSA technique. Early (o30 day)
Gastrojejunostomy Technique Complications / Surgery for Obesity and Related Diseases ] (2015) 00–00
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Table 1 Patient data and demographic characteristics Variable
Hand-sewn
Stapled
Cumulative
Patients n (%) Female Age (yrs) Pre-op BMI (kg/m2) Race African American Caucasian Hispanic Asian Other Co-morbidities Diabetes Mellitus GERD Obstructive Sleep Apnea Asthma Hypertension Cardiovascular Disease Chronic Renal Insufficiency Factor V Leiden Mutation History of DVT/PE ASA Score Operative Time (min) Length of Stay
135 111 (82.2%) 44.1 (⫾11.0) 48.7 (⫾7.8)
55 44 (80.0%) 44.2 (⫾11.1) 49.9 (⫾7.7)
190 155 (81.6%) 44.1 (⫾11.1) 49.1 (⫾7.8)
P value .84 .98 .37
32 97 2 1 3
(23.7%) (71.8%) (1.5%) (0.7%) (2.2%)
12 40 0 1 2
(21.8%) (72.7%) (0.0%) (1.8%) (3.6%)
44 137 2 2 5
(23.1%) (72.1%) (1.1%) (1.1%) (2.6%)
.84 1.00 1.00 1.00 .63
53 37 43 28 81 2 1 1 5 2.8 213 2.2
(39.3%) (27.4%) (31.9%) (20.7%) (60%) (1.5%) (0.7%) (0.7%) (3.7%) (⫾0.4) (⫾44.1) (⫾0.6)
26 16 25 10 34 1 3 1 1 2.9 170 2.3
(47.3%) (29.1%) (45.5%) (18.2%) (61.8%) (1.8%) (5.5%) (1.8%) (1.8%) (⫾0.3) (⫾36.4) (⫾0.6)
79 53 68 38 115 3 4 2 6 2.8 201 2.2
(41.6%) (27.9)% (35.8%) (20%) (60.5%) (1.6%) (2.1%) (1.1%) (3.2%) (⫾0.4) (⫾46.2) (⫾0.6)
.33 .86 .10 .84 .87 1.00 .07 1.00 .67 .14 o .01 .60
ASA ¼ American Society of Anesthesiologists; DVT/PE ¼ Deep vein thrombosis/pulmonary embolism; GERD ¼ Gastroesophageal reflux disease Reported as mean (⫾SD). One patient was considered an outlier and excluded from the length of stay calculation.
reoperations in the CSA study group were secondary to unexplained pain and tachycardia with negative diagnostic laparoscopy, laparoscopy for bleeding and intraabdominal hematoma evacuation (3), incarcerated port site hernia repair (2), and acute appendicitis in the 30-day postoperative period necessitating appendectomy. In the HSA study group, there were 2 reoperations: one secondary to intraabdominal bleeding and one Roux-limb obstruction. There were no internal hernias reported in either group. Most
complications were Clavien Classification Grade III (requiring endoscopic, radiologic, or surgical intervention) and are detailed in Table 3. Discussion The laparoscopic Roux-en-Y gastric bypass is the most frequently employed surgical procedure for obesity in the United States [6]. A 2008 study by Madan et al. found that
Table 2 Outcomes within 12 months after laparoscopic Roux-en-Y gastric bypass surgery
Anastomotic Stenosis Marginal Ulcer Wound Infection Postop Bleeding DVT/PE Nausea/Dehydration/ Abdominal Pain Early (o30 day) reoperation Endoscopic Dilations Other Complications %EWL %EBMIL Lost to Follow-Up @ 12 months
Hand-sewn
Stapled
Cumulative
P value
4 1 0 2 0 5 2 4 5 61.3 69.4 29
9 3 2 6 2 2 7 10 4 68.1 76.6 6
13 4 2 8 2 7 9 14 9 63.4 71.7 35
o .01 .04 .16 o .01 .16 .49 o .01 o .01 .30 .07 .11 .09
(3.0%) (0.7%) (0.0%) (1.5%) (0.0%) (3.7%) (1.5%) (3.0%) (3.7%) (⫾19.2) (⫾23.0) (21%)
(16.4%) (5.5%) (3.6%) (10.9%) (3.6%) (3.6%) (12.7%) (18.2%) (7.3%) (⫾16.3) (⫾21.0) (11%)
(6.8%) (2.1%) (1.1%) (4.2%) (1.1%) (3.6%) (4.7%) (7.4%) (4.7%) (⫾18.5) (⫾22.6) (19%)
DVT/PE ¼ Deep vein thrombosis/pulmonary embolism; %EBMIL ¼ percent excess BMI loss; %EWL ¼ percent excess weight loss. Other complications included a hernia recurrence, postsurgical atelectasis, unexplained postsurgical pain, fluid overload, and a fatal cardiac arrhythmia in the Hand-sewn cohort and hypoglycemia/hyperinsulinemia, diabetic ketoacidosis, acute renal insufficiency secondary to a urinary tract infection, and gastroenteritis in the stapled cohort.
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Table 3 12-Month Complication Incidence According to Clavien Grade Clavien Class
Grade I Grade II Grade III* Grade IV* Grade V Total*
Hand-sewn
Stapled
o30 Days
430 Days
o30 Days
430 Days
5 3 1 0 1 10
2 0 6 0 0 8
2 5 7 1 1 16
0 2 10 0 0 12
Clavien Grade I ¼ deviation from postop course not requiring pharmacologic or surgical intervention; II ¼ requiring pharmacologic intervention; III ¼ intervention requiring general anesthesia; IV ¼ resulting in organ system dysfunction; V ¼ resulting in death. *P value o .01 for 2-tailed t test comparing the total number of complications for the corresponding Clavien Class. There were 0 patients lost to follow-up at 30 days and 35 patients at 12 months (19%).
21% of bariatric surgeons prefer a hand-sewn technique for the gastrojejunostomy and 43% prefer the circular-stapled technique [7]. A retrospective review of our experience suggests that the CSA technique for creating the gastrojejunostomy is associated with decreased operative time and an increased incidence of both early and late anastomotic complications compared to the HSA technique. Length of stay and weight loss did not differ significantly between the CSA and HSA techniques in this study. These data are consistent with current literature regarding gastrojejunostomy technique dependent outcomes [1,8,9]. Gastrojejunostomy stenosis following laparoscopic gastric bypass has been reported to occur with differing frequencies depending on the technique, definition, and clinical series. The stenosis rate in the current series is comparable with reported ranges in the literature, with 3.4–33.3% for the hand-sewn gastrojejunostomy and 6.2–31.0% for the 25 mm CSA technique [3,8]. The postulated mechanisms underlying stricture formation are local tissue ischemia, tension on the anastomosis, subclinical leak, submucosal hematoma, acid or peptic ulceration, early experience with laparoscopic gastric bypass, and method of gastrojejunostomy construction [10]. In the CSA technique, smaller circular stapler diameter has been demonstrated to correlate with an increased rate of gastrojejunostomy stenosis [11]. Anastomotic stenosis rates vary greatly between clinical series utilizing the same gastrojejunostomy technique, supporting a multifactorial etiology to gastrojejunostomy strictures and marginal ulcers. Based on the published literature, it appears as if the rates of these anastomotic complications are lowest in patients receiving a HSA gastrojejunostomy. Wound infections were higher in our patients undergoing CSA in this series. This is likely related to the passing of the circular stapler through the abdominal wall and directly into the GI tract, without the use of a trocar. In the HSA technique, the abdominal trocars are not removed and a specimen is not retrieved from the abdomen (CSA technique requires a small piece of jejunum proximal to the gastrojejunostomy to be
resected to complete the anastomosis). Penna et al. performed a meta-analysis of 9 trials comparing linear stapled to circular stapled gastrojejunostomy in laparoscopic gastric bypass [12]. Gastrojejunostomy stenosis and wound infections were far more common with the circular stapled technique, likely for the similar reasons as above. Finks et al. analyzed data from the Michigan Bariatric Surgery Collaborative and found in 9,904 patients, wound infection was far more common with the circular stapled technique (4.7%) than with linear stapled (1.6%) or hand-sewn anastomosis (0.6%, CS 4.7%, LS 1.6%, P o .0001) [13]. Patients in this study experienced a relatively high rate of postoperative bleeding complications (4.2%). Bleeding was significantly more common in CSA (10.9%) versus HSA (1.5%) patients. There were no episodes of marginal ulcer bleeding in this study. In the CSA study group, early postoperative gastrointestinal bleeding (melena or hematemesis) was more common than intraabdominal bleeding. All episodes of early postoperative gastrointestinal bleeding were managed by discontinuing anticoagulation medications and expectant management with or without transfusion. In the HSA anastomotic technique, both the jejunum and the gastric pouch are opened at the area of the anastomosis. Mucosal bleeding from the tissue that will eventually become the anastomosis is visualized immediately and can be controlled before the anastomosis is complete. In the CSA technique, especially when the circular stapler anvil is passed transgastrically through a gastrotomy remote from the eventual gastrojejunostomy, the mucosa of the perianastomotic tissue is never visualized. Gastrointestinal bleeding from a fresh anastomotic staple line would not be visualized until this became clinically apparent in the postoperative period. A 2-layered hand sewn anastomosis may also be more hemostatic than a staple line. A metaanalysis of linear versus circular stapled gastrojejunostomy found a significantly lower rate of bleeding in linear stapled gastrojejunostomy [12]. In the linear stapled technique, the mucosa of the anastomosis can be directly
Gastrojejunostomy Technique Complications / Surgery for Obesity and Related Diseases ] (2015) 00–00
visualized before closing the common enterotomy as in the HSA technique. In the Michigan Bariatric Surgery Collaborative, the CSA technique was associated with a significantly higher rate of bleeding compared with HSA and linear stapled gastrojejunostomy [13]. It appears as if the CSA technique is inherently associated with a higher rate of bleeding. One strategy that may be effective in decreasing the rate of bleeding complications in circular stapled gastrojejunostomy gastric bypass is intraoperative endoscopy, although this has yet to be demonstrated definitely [14]. Reoperations following bariatric surgery are an important quality metric. It has been demonstrated that reoperations are associated with significantly higher morbidity and mortality in bariatric surgery [15]. Reoperations were significantly more common following CSA than HSA gastric bypass in our experience. In the CSA study group, reoperations were primarily related to bleeding and acute port site hernia with associated bowel obstruction. We use a 25 mm circular stapler passed through the abdominal wall. The fascia is always closed with a suture passer at the end of the case. Both acute hernias resulting in reoperation occurred at this site in the CSA study group. As referenced above in the discussion on wound infections, this is not an issue in the HSA technique since all ports are 12 mm or smaller, and the fascia never needs to be dilated to accommodate a larger stapler. Weight loss outcomes at one-year postsurgery did not differ between the gastrojejunostomy techniques employed in this study. Previous research has failed to establish a clear link between gastrojejunostomy caliber and weight loss. Most studies to examine the impact of different gastrojejunostomy construction techniques (when the gastrojejunostomy internal diameter differs between study groups) on weight loss demonstrate equivalent outcomes. Cottam et al. conducted a prospective randomized clinical trial in patients undergoing laparoscopic gastric bypass with a 21 mm or 25 mm circular stapled gastrojejunostomy [16]. While the rate of stenosis and the need for endoscopic dilation was significantly higher in the 21 mm stapler group, weight loss at 2 years was identical in the 2 study groups (480% excess weight loss). Smith et al. conducted a retrospective review of the impact of circular stapler size on long-term weight loss and determined that weight loss was similar with 21 mm and 25 mm circular-stapled gastrojejunostomy at 5-year follow-up [17]. A metaanalysis analyzing published studies comparing linear to circular stapled gastrojejunostomy in LRYGB revealed no difference in weight loss at one-year postop [2]. A technical difference between the 2 study groups that warrants further discussion is the location of the Roux-limb with regards to the colon. Patients in the HSA group had a retrocolic Roux limb and CSA patients were antecolic. There are several published studies to examine the impact of Roux-limb location on clinical outcomes with various conclusions. Two different studies found no difference in
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either weight loss or complications based on Roux-limb position [18,19]. Another retrospective review of a 3 surgeon cases series revealed a higher leak rate in cases where the Roux-limb was placed in the antecolic position [20]. The antecolic position was demonstrated on retrospective review of 2 different large case series to be associated with fewer internal hernias [21] and a lower rate of intestinal obstruction [22]. The only prospective randomized trial to evaluate the relationship between Roux-limb position and outcomes failed to demonstrate an effect [23]. It is possible that the different Roux-limb positions in the 2 groups for our study may contribute to some of our findings, although we believe this is not likely based on the above. With a learning curve that has been estimated to be 100 cases or more, laparoscopic Roux-en-Y gastric bypass is not easily mastered [24,25]. None of the cases in the present study took place during the early experience period of either surgeon. Each surgeon had performed 4500 cases as the primary bariatric surgeon using their respective technique before this review. The technical complexity of the HSA technique is high, and morbidity as well as operative times can be increased early in a surgeon’s experience. BallestaLópez et al. reported a 44% leak rate in the first 18 patients of a 600 patient series of laparoscopic Roux-en Y gastric bypass with HSA [26]. This ‘learning curve’ effect on morbidity in laparoscopic gastric bypass surgery may be minimized by participation in a robust training program [27,28]. Potential limitations of this study include the retrospective nature, relatively small sample sizes, and incomplete long-term follow-up. Based on these data, we have demonstrated that in our experience the CSA technique of gastrojejunostomy construction is associated with a shorter operative time and similar length of stay following surgery, but a higher incidence of nonlife threatening anastomotic complications compared to the HSA technique. Weight loss does not appear to differ based on anastomotic technique. These findings and our review of the literature lead us to believe that the HSA technique is superior to the CSA technique. We did not evaluate the linear stapled gastrojejunostomy technique in this study. Given the above, strong consideration should be given to moving away from high utilization of the CSA technique in laparoscopic gastric bypass as is the practice across the country at the current time. Disclosures Dr. Wallace, Alex Lois, and Matthew Frelich have no conflicts of interest. Dr. Gould is a consultant for Torax Medical. Dr. Goldblatt receives funding support for research from WL Gore and Davol Inc. He is also a speaker for Covidien. Funding provided by Department of Surgery, Division of General Surgery, Medical College of Wisconsin.
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Original article
Gastrojejunostomy Technique and Anastomotic Complications in Laparoscopic Gastric Bypass Alex W. Lois, B.S., Matthew J. Frelich, M.S., Matthew I. Goldblatt, M.D., James R. Wallace, M.D., PhD, Jon C. Gould, M.D.* Medical College of Wisconsin, Department of Surgery, Milwaukee, Wisconsin Received August 3, 2014; accepted November 8, 2014
Abstract
Background: Various surgical techniques exist to create the gastrojejunostomy during laparoscopic Roux-en-Y gastric bypasses (LRYGB). A hand-sewn anastomosis (HSA) and circular-stapled anastomosis (CSA) are both common techniques. We hypothesized that the CSA was associated with a greater incidence of anastomotic complications. As a secondary aim, we sought to determine if weight loss varied by technique. Methods: This study is a retrospective review of patients who underwent primary LRYGB at the Medical College of Wisconsin from January 2010 to December 2011. Procedures were performed by one of 2 surgeons, each with a preferred gastrojejunostomy technique. Clinical information and patient outcomes were followed up to one year. Results: A total of 190 patients underwent LRYGB during the study interval. The majority of patients underwent HSA. Forty-one of 190 (21.6%) patients experienced one or more complications. Most complications were Clavien Classification Grade III and were experienced within 30 days of surgery in 3 (2.2%) HSA patients and 6 (10.9%) CSA patients (P ¼ .02). Anastomotic complications occurred more frequently with the CSA technique (marginal ulcer 5.5% CSA versus .7% HSA; P ¼ .04 and stenosis 16.4% CSA versus 3% HSA; P ¼ .01). There were no gastrojejunostomy leaks in this series. Operative time was significantly longer in HSA patients (204 minutes HSA versus 166 minutes CSA; P o .01), but length of hospital stay did not differ. Weight loss at 12 months was similar between techniques (69.4% percent excess BMI lost (EBMIL) HSA versus 76.6% EBMIL CSA; P ¼ .11). No patients were lost to follow-up at 30 days. Thirty-five patients (19%) were lost to follow-up by one year. Conclusion: The CSA technique of gastrojejunostomy in gastric bypass is associated with a higher rate of nonlife threatening anastomotic complications than the HSA technique. Operative times are significantly longer for HSA, but length of hospital stay (LOS) and long-term weight loss are equivalent. (Surg Obes Relat Dis 2015;]:00–00.) r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Gastrojejunostomy; Anastomosis; Hand-sewn; Circular-stapled; Complications
Background Presented as a Poster at the annual SAGES meeting, April 4, 2014, Salt Lake City, UT * Correspondence: Jon C. Gould, M.D. Medical College of Wisconsin, Department of Surgery, 9200 West Wisconsin Ave, Milwaukee, WI 53226, USA. Tel.: 414-805-5928. Fax: 414-454-0152. E-mail: [email protected]
Several different surgical techniques are commonly employed to create the gastrojejunostomy during laparoscopic Roux-en-Y gastric bypass surgery [1]. Depending upon their preference, surgeons may choose a hand-sewn anastomosis (HSA), circular-stapled anastomosis (CSA), or linear-stapled anastomosis (LSA). Complications among the
http://dx.doi.org/10.1016/j.soard.2014.11.029 1550-7289/r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.
A. W. Lois et al. / Surgery for Obesity and Related Diseases ] (2015) 00–00
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3 techniques may vary in incidence and can include gastrojejunostomy stenosis, marginal ulcer, and wound infections. These anastomotic techniques also differ in terms of technical difficulty and operative time [2,3]. Surgeons in our bariatric surgery program perform laparoscopic Roux-en-Y gastric bypass using both the HSA and CSA technique. We hypothesized that the CSA technique was associated with a greater incidence of anastomotic complications such as marginal ulcer and stenosis. As a secondary aim, we also sought to determine if weight loss outcomes varied by technique. Methods After Institutional Review Board approval, a retrospective review of prospectively collected data was undertaken to compare outcomes for patients undergoing laparoscopic gastric bypass with the HSA and CSA techniques over a 2year period (January 2010 to December 2011). All procedures were performed by one of 2 surgeons who each utilized different gastrojejunostomy construction techniques. Perioperative and postoperative outcomes to 12 months were reviewed. Weight loss was evaluated using 2 metrics, %EBMIL (percent excess BMI lost) and %EWL (percent excess weight loss), which were calculated according to the following formulas [4]: %EBMIL ¼
preoperative BMI – postoperative BMI 100 preoperative BMI – 25
and %EWL ¼
preoperative weight – postoperative weight 100 preoperative weight – ideal weight
Ideal weight was estimated using the middle value of the 1983 Metropolitan Life Insurance tables for median frame. When calculating the operative time and length of hospital stay (LOS), only laparoscopic gastric bypass procedures without concomitant procedures (such as incisional hernia repair and cholecystectomy) were included. Complications were graded by the intervention required according to the Clavien Classification System [5]. Briefly, Clavien grade I is deviation from postoperative course not requiring pharmacologic or surgical intervention; grade II requires pharmacologic intervention; grade III is an intervention requiring general anesthesia; grade IV results in organ system dysfunction; and grade V results in death. Patients with multiple complications resolved by a single intervention were counted as one complication (for example a patient with a marginal ulcer and gastrojejunostomy stenosis both resolved with endoscopic dilation). Stenosis was defined as a gastrojejunostomy diameter less than that of a therapeutic endoscope (11 mm) in a symptomatic patient (pain, dysphagia, vomiting). Gastrojejunostomy stenosis was diagnosed and treated with serial endoscopic balloon dilation. Anastomotic ulcers were diagnosed endoscopically.
They were treated with a 30-day regimen consisting of high dose acid suppression in conjunction with Carafate daily. For the hand-sewn anastomosis, a 2-layer hand-sewn technique with absorbable sutures was used to create the gastrojejunostomy around a 32French tube resulting in a 10mm diameter anastomosis. A 20 mL isolated gastric pouched was created following measurement of the Rouxlimb. The anastomosis was made in the inferior-lateral corner of the pouch staple line. A running 3-0 Vicryl suture with seromuscular bites was used for an outer layer of Lembert sutures and a running 3-0 Vicryl with full thickness bites was used for the inner layer of sutures. In the majority of patients undergoing LRYGB with the HSA technique, the Roux-limb was placed in the retrocolic, antegastric location. When this placement was not possible, an antecolic placement was used. The CSA technique involved the transgastric placement of a 25 mm circular stapler anvil. A 20 mL isolated gastric pouch was created once the anvil had been placed. As a result, the gastrojejunostomy was located on the anteriorinferior wall of the gastric pouch. Care was taken to ensure that the circular staple line and the pouch staple line did not cross. Oversewing of the gastrojejunostomy was not routinely performed unless the integrity of the staple line was in question. In these cases, Vicryl sutures were used. Leak tests were performed intraoperatively as a routine in all patients in this study. The Roux-limb was routinely placed in the antecolic, antegastric location for all CSA procedures. Statistical analysis of our data was conducted using VassarStats (Vassar College, Poughkeepsie, NY). Twotailed Fisher’s exact test was used to compare categorical data, and continuous data was compared using 2-tailed T tests. A P value o .05 was considered statistically significant. Results There were a total of 190 patients who underwent laparoscopic Roux-en Y gastric bypass during the study interval. Demographic characteristics did not differ significantly between study groups and are detailed in Table 1. The majority of patients underwent HSA. Of the 190 patients, 155 (81%) completed follow-up to at least 12 months. Follow-up at 30 days was 100% and follow-up at 6 months was 95%. The HSA technique was associated with a significantly longer operative time, but a similar LOS (Table 1). There was no significant difference in mean %EBMIL or %EWL between HSA and CSA at 12 months (Table 2). The overall morbidity rate was 21.6%, with 41 of the 190 patients experiencing at least one complication. Four patients experienced 2 or more complications. Complications are described in detail in [Table 2. Stenosis at the gastrojejunostomy and anastomotic ulcers were observed more frequently in CSA patients. Wound infections and reoperations occurred at a low rate overall, but were more common with the CSA technique. Early (o30 day)
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Table 1 Patient data and demographic characteristics Variable
Hand-sewn
Stapled
Cumulative
Patients n (%) Female Age (yrs) Pre-op BMI (kg/m2) Race African American Caucasian Hispanic Asian Other Co-morbidities Diabetes Mellitus GERD Obstructive Sleep Apnea Asthma Hypertension Cardiovascular Disease Chronic Renal Insufficiency Factor V Leiden Mutation History of DVT/PE ASA Score Operative Time (min) Length of Stay
135 111 (82.2%) 44.1 (⫾11.0) 48.7 (⫾7.8)
55 44 (80.0%) 44.2 (⫾11.1) 49.9 (⫾7.7)
190 155 (81.6%) 44.1 (⫾11.1) 49.1 (⫾7.8)
P value .84 .98 .37
32 97 2 1 3
(23.7%) (71.8%) (1.5%) (0.7%) (2.2%)
12 40 0 1 2
(21.8%) (72.7%) (0.0%) (1.8%) (3.6%)
44 137 2 2 5
(23.1%) (72.1%) (1.1%) (1.1%) (2.6%)
.84 1.00 1.00 1.00 .63
53 37 43 28 81 2 1 1 5 2.8 213 2.2
(39.3%) (27.4%) (31.9%) (20.7%) (60%) (1.5%) (0.7%) (0.7%) (3.7%) (⫾0.4) (⫾44.1) (⫾0.6)
26 16 25 10 34 1 3 1 1 2.9 170 2.3
(47.3%) (29.1%) (45.5%) (18.2%) (61.8%) (1.8%) (5.5%) (1.8%) (1.8%) (⫾0.3) (⫾36.4) (⫾0.6)
79 53 68 38 115 3 4 2 6 2.8 201 2.2
(41.6%) (27.9)% (35.8%) (20%) (60.5%) (1.6%) (2.1%) (1.1%) (3.2%) (⫾0.4) (⫾46.2) (⫾0.6)
.33 .86 .10 .84 .87 1.00 .07 1.00 .67 .14 o .01 .60
ASA ¼ American Society of Anesthesiologists; DVT/PE ¼ Deep vein thrombosis/pulmonary embolism; GERD ¼ Gastroesophageal reflux disease Reported as mean (⫾SD). One patient was considered an outlier and excluded from the length of stay calculation.
reoperations in the CSA study group were secondary to unexplained pain and tachycardia with negative diagnostic laparoscopy, laparoscopy for bleeding and intraabdominal hematoma evacuation (3), incarcerated port site hernia repair (2), and acute appendicitis in the 30-day postoperative period necessitating appendectomy. In the HSA study group, there were 2 reoperations: one secondary to intraabdominal bleeding and one Roux-limb obstruction. There were no internal hernias reported in either group. Most
complications were Clavien Classification Grade III (requiring endoscopic, radiologic, or surgical intervention) and are detailed in Table 3. Discussion The laparoscopic Roux-en-Y gastric bypass is the most frequently employed surgical procedure for obesity in the United States [6]. A 2008 study by Madan et al. found that
Table 2 Outcomes within 12 months after laparoscopic Roux-en-Y gastric bypass surgery
Anastomotic Stenosis Marginal Ulcer Wound Infection Postop Bleeding DVT/PE Nausea/Dehydration/ Abdominal Pain Early (o30 day) reoperation Endoscopic Dilations Other Complications %EWL %EBMIL Lost to Follow-Up @ 12 months
Hand-sewn
Stapled
Cumulative
P value
4 1 0 2 0 5 2 4 5 61.3 69.4 29
9 3 2 6 2 2 7 10 4 68.1 76.6 6
13 4 2 8 2 7 9 14 9 63.4 71.7 35
o .01 .04 .16 o .01 .16 .49 o .01 o .01 .30 .07 .11 .09
(3.0%) (0.7%) (0.0%) (1.5%) (0.0%) (3.7%) (1.5%) (3.0%) (3.7%) (⫾19.2) (⫾23.0) (21%)
(16.4%) (5.5%) (3.6%) (10.9%) (3.6%) (3.6%) (12.7%) (18.2%) (7.3%) (⫾16.3) (⫾21.0) (11%)
(6.8%) (2.1%) (1.1%) (4.2%) (1.1%) (3.6%) (4.7%) (7.4%) (4.7%) (⫾18.5) (⫾22.6) (19%)
DVT/PE ¼ Deep vein thrombosis/pulmonary embolism; %EBMIL ¼ percent excess BMI loss; %EWL ¼ percent excess weight loss. Other complications included a hernia recurrence, postsurgical atelectasis, unexplained postsurgical pain, fluid overload, and a fatal cardiac arrhythmia in the Hand-sewn cohort and hypoglycemia/hyperinsulinemia, diabetic ketoacidosis, acute renal insufficiency secondary to a urinary tract infection, and gastroenteritis in the stapled cohort.
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Table 3 12-Month Complication Incidence According to Clavien Grade Clavien Class
Grade I Grade II Grade III* Grade IV* Grade V Total*
Hand-sewn
Stapled
o30 Days
430 Days
o30 Days
430 Days
5 3 1 0 1 10
2 0 6 0 0 8
2 5 7 1 1 16
0 2 10 0 0 12
Clavien Grade I ¼ deviation from postop course not requiring pharmacologic or surgical intervention; II ¼ requiring pharmacologic intervention; III ¼ intervention requiring general anesthesia; IV ¼ resulting in organ system dysfunction; V ¼ resulting in death. *P value o .01 for 2-tailed t test comparing the total number of complications for the corresponding Clavien Class. There were 0 patients lost to follow-up at 30 days and 35 patients at 12 months (19%).
21% of bariatric surgeons prefer a hand-sewn technique for the gastrojejunostomy and 43% prefer the circular-stapled technique [7]. A retrospective review of our experience suggests that the CSA technique for creating the gastrojejunostomy is associated with decreased operative time and an increased incidence of both early and late anastomotic complications compared to the HSA technique. Length of stay and weight loss did not differ significantly between the CSA and HSA techniques in this study. These data are consistent with current literature regarding gastrojejunostomy technique dependent outcomes [1,8,9]. Gastrojejunostomy stenosis following laparoscopic gastric bypass has been reported to occur with differing frequencies depending on the technique, definition, and clinical series. The stenosis rate in the current series is comparable with reported ranges in the literature, with 3.4–33.3% for the hand-sewn gastrojejunostomy and 6.2–31.0% for the 25 mm CSA technique [3,8]. The postulated mechanisms underlying stricture formation are local tissue ischemia, tension on the anastomosis, subclinical leak, submucosal hematoma, acid or peptic ulceration, early experience with laparoscopic gastric bypass, and method of gastrojejunostomy construction [10]. In the CSA technique, smaller circular stapler diameter has been demonstrated to correlate with an increased rate of gastrojejunostomy stenosis [11]. Anastomotic stenosis rates vary greatly between clinical series utilizing the same gastrojejunostomy technique, supporting a multifactorial etiology to gastrojejunostomy strictures and marginal ulcers. Based on the published literature, it appears as if the rates of these anastomotic complications are lowest in patients receiving a HSA gastrojejunostomy. Wound infections were higher in our patients undergoing CSA in this series. This is likely related to the passing of the circular stapler through the abdominal wall and directly into the GI tract, without the use of a trocar. In the HSA technique, the abdominal trocars are not removed and a specimen is not retrieved from the abdomen (CSA technique requires a small piece of jejunum proximal to the gastrojejunostomy to be
resected to complete the anastomosis). Penna et al. performed a meta-analysis of 9 trials comparing linear stapled to circular stapled gastrojejunostomy in laparoscopic gastric bypass [12]. Gastrojejunostomy stenosis and wound infections were far more common with the circular stapled technique, likely for the similar reasons as above. Finks et al. analyzed data from the Michigan Bariatric Surgery Collaborative and found in 9,904 patients, wound infection was far more common with the circular stapled technique (4.7%) than with linear stapled (1.6%) or hand-sewn anastomosis (0.6%, CS 4.7%, LS 1.6%, P o .0001) [13]. Patients in this study experienced a relatively high rate of postoperative bleeding complications (4.2%). Bleeding was significantly more common in CSA (10.9%) versus HSA (1.5%) patients. There were no episodes of marginal ulcer bleeding in this study. In the CSA study group, early postoperative gastrointestinal bleeding (melena or hematemesis) was more common than intraabdominal bleeding. All episodes of early postoperative gastrointestinal bleeding were managed by discontinuing anticoagulation medications and expectant management with or without transfusion. In the HSA anastomotic technique, both the jejunum and the gastric pouch are opened at the area of the anastomosis. Mucosal bleeding from the tissue that will eventually become the anastomosis is visualized immediately and can be controlled before the anastomosis is complete. In the CSA technique, especially when the circular stapler anvil is passed transgastrically through a gastrotomy remote from the eventual gastrojejunostomy, the mucosa of the perianastomotic tissue is never visualized. Gastrointestinal bleeding from a fresh anastomotic staple line would not be visualized until this became clinically apparent in the postoperative period. A 2-layered hand sewn anastomosis may also be more hemostatic than a staple line. A metaanalysis of linear versus circular stapled gastrojejunostomy found a significantly lower rate of bleeding in linear stapled gastrojejunostomy [12]. In the linear stapled technique, the mucosa of the anastomosis can be directly
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visualized before closing the common enterotomy as in the HSA technique. In the Michigan Bariatric Surgery Collaborative, the CSA technique was associated with a significantly higher rate of bleeding compared with HSA and linear stapled gastrojejunostomy [13]. It appears as if the CSA technique is inherently associated with a higher rate of bleeding. One strategy that may be effective in decreasing the rate of bleeding complications in circular stapled gastrojejunostomy gastric bypass is intraoperative endoscopy, although this has yet to be demonstrated definitely [14]. Reoperations following bariatric surgery are an important quality metric. It has been demonstrated that reoperations are associated with significantly higher morbidity and mortality in bariatric surgery [15]. Reoperations were significantly more common following CSA than HSA gastric bypass in our experience. In the CSA study group, reoperations were primarily related to bleeding and acute port site hernia with associated bowel obstruction. We use a 25 mm circular stapler passed through the abdominal wall. The fascia is always closed with a suture passer at the end of the case. Both acute hernias resulting in reoperation occurred at this site in the CSA study group. As referenced above in the discussion on wound infections, this is not an issue in the HSA technique since all ports are 12 mm or smaller, and the fascia never needs to be dilated to accommodate a larger stapler. Weight loss outcomes at one-year postsurgery did not differ between the gastrojejunostomy techniques employed in this study. Previous research has failed to establish a clear link between gastrojejunostomy caliber and weight loss. Most studies to examine the impact of different gastrojejunostomy construction techniques (when the gastrojejunostomy internal diameter differs between study groups) on weight loss demonstrate equivalent outcomes. Cottam et al. conducted a prospective randomized clinical trial in patients undergoing laparoscopic gastric bypass with a 21 mm or 25 mm circular stapled gastrojejunostomy [16]. While the rate of stenosis and the need for endoscopic dilation was significantly higher in the 21 mm stapler group, weight loss at 2 years was identical in the 2 study groups (480% excess weight loss). Smith et al. conducted a retrospective review of the impact of circular stapler size on long-term weight loss and determined that weight loss was similar with 21 mm and 25 mm circular-stapled gastrojejunostomy at 5-year follow-up [17]. A metaanalysis analyzing published studies comparing linear to circular stapled gastrojejunostomy in LRYGB revealed no difference in weight loss at one-year postop [2]. A technical difference between the 2 study groups that warrants further discussion is the location of the Roux-limb with regards to the colon. Patients in the HSA group had a retrocolic Roux limb and CSA patients were antecolic. There are several published studies to examine the impact of Roux-limb location on clinical outcomes with various conclusions. Two different studies found no difference in
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either weight loss or complications based on Roux-limb position [18,19]. Another retrospective review of a 3 surgeon cases series revealed a higher leak rate in cases where the Roux-limb was placed in the antecolic position [20]. The antecolic position was demonstrated on retrospective review of 2 different large case series to be associated with fewer internal hernias [21] and a lower rate of intestinal obstruction [22]. The only prospective randomized trial to evaluate the relationship between Roux-limb position and outcomes failed to demonstrate an effect [23]. It is possible that the different Roux-limb positions in the 2 groups for our study may contribute to some of our findings, although we believe this is not likely based on the above. With a learning curve that has been estimated to be 100 cases or more, laparoscopic Roux-en-Y gastric bypass is not easily mastered [24,25]. None of the cases in the present study took place during the early experience period of either surgeon. Each surgeon had performed 4500 cases as the primary bariatric surgeon using their respective technique before this review. The technical complexity of the HSA technique is high, and morbidity as well as operative times can be increased early in a surgeon’s experience. BallestaLópez et al. reported a 44% leak rate in the first 18 patients of a 600 patient series of laparoscopic Roux-en Y gastric bypass with HSA [26]. This ‘learning curve’ effect on morbidity in laparoscopic gastric bypass surgery may be minimized by participation in a robust training program [27,28]. Potential limitations of this study include the retrospective nature, relatively small sample sizes, and incomplete long-term follow-up. Based on these data, we have demonstrated that in our experience the CSA technique of gastrojejunostomy construction is associated with a shorter operative time and similar length of stay following surgery, but a higher incidence of nonlife threatening anastomotic complications compared to the HSA technique. Weight loss does not appear to differ based on anastomotic technique. These findings and our review of the literature lead us to believe that the HSA technique is superior to the CSA technique. We did not evaluate the linear stapled gastrojejunostomy technique in this study. Given the above, strong consideration should be given to moving away from high utilization of the CSA technique in laparoscopic gastric bypass as is the practice across the country at the current time. Disclosures Dr. Wallace, Alex Lois, and Matthew Frelich have no conflicts of interest. Dr. Gould is a consultant for Torax Medical. Dr. Goldblatt receives funding support for research from WL Gore and Davol Inc. He is also a speaker for Covidien. Funding provided by Department of Surgery, Division of General Surgery, Medical College of Wisconsin.
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