Single Anastomosis Duodeno-ileal Bypass As a Revisional Procedure Following Sleeve Gastrectomy: Review of the Literature.

Laparoscopic sleeve gastrectomies (LSGs) can experience weight-loss failure and conversion to another bariatric procedure. An analysis of the bariatric literature concerning the single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) as revisional surgery after LSG in terms of safety and efficacy identified 607 studies. Fifty-nine studies were analyzed for full content review and 9 primary studies (398 patients) were included. Revisional single anastomosis duodeno-ileal bypass (SADI) was performed in 294 patients at a mean interval of 37.7 months (range 11-179). Total weight loss (%) varies from 20.5% to 46.2%. Early complications after surgery occurred in 4.1% surgeries including leak (7 cases -1.9%). Mortality was nil. SADI after LSG, after failed sleeve gastrectomy or as a sequential procedure, offers a satisfactory weight loss result. Both early and late term complications are acceptable.

Management of Leak after Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy.

The single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been introduced in the past few years for the treatment of morbid obesity. SADI-S has shown good results in terms of long-term results and short-term complications. However, the management of patients undergoing SADI-S and suffering from a leak is a great challenge for surgeons. We present an extensive review of the currently available literature on the management of leak after SADI in morbid obese (MO) patients. We aim at providing objective information regarding the optimal management, including diagnosis, technical options for the different strategies that have been proposed, to facilitate the selection of the best individual approach for each MO patient.

Abdominal Wall Hernia and Metabolic Bariatric Surgery.

The management of morbidly obese patients with a concomitant ventral hernia (VH) is a great challenge for surgeons. There is controversy over the optimal strategy to tackle both health problems, requiring an individualized approach. Obese patients have a higher recurrence rate after hernia repair, and bariatric surgery in the presence of a VH can be difficult. As morbid obesity is related with severe comorbidities, including increased cardiovascular and anesthetic risks, some advocate for a single-stage strategy. A primary hernia repair carried out during the bariatric surgery, however, may increase morbidity without definitively solving the problem. Biological meshes are expensive and also have a high recurrence rate. The laparoscopic placement of a synthetic mesh offers good results, but it is worrisome because bariatric surgery is a clean-contaminated procedure. Moreover, there is a great chance that a plastic surgery would be necessary after completing the weight-loss process, and the abdominal wall surgery could be performed at that point. There are many arguments, but the evidence is weak. We present an extensive review of the currently available literature on the management of VH in morbidly obese patients. We aim to provide objective information regarding the pros and cons of the different strategies that have been proposed, to facilitate the selection of the best approach to individual morbidly obese patients with abdominal wall hernias precising both of surgical repair.

Use of Topical Antibiotics before Primary Incision Closure to Prevent Surgical Site Infection: A Meta-Analysis.

Background: Surgical site infections (SSIs) remains a concern for surgeons because of the negative impact on outcomes and health care costs. Our purpose was to assess whether topical antibiotics before primary incision closure reduced the rate of SSIs. Methods: Systematic review of MEDLINE/PubMed, Scopus, CINAHL, and Web of Science databases from inception to January 2017. Only randomized controlled trials (RCTs) were retrieved. The primary outcome was the SSI rate. Meta-analysis was complemented with trial sequential analysis (TSA). Results: Thirty-five RCTs (10,870 patients) were included. Only ß-lactams and aminoglycosides were used. A substantial reduction of the incidence of SSIs with the application of antibiotic agents before incision closure (risk ratio [RR] 0.49, 95% confidence interval [CI] 0.37-0.64) was found, which remained in the analysis of 12 RCTs after removal of studies of uncertain quality. The use of ß-lactams was effective to reduce SSI in elective surgery only (RR 0.33, 95% CI 0.13-0.85). In clean-contaminated fields and as an irrigation solution, ß-lactams did not reduce the risk of SSI. Aminoglycosides were not effective (RR 0.74, 95% CI 0.49-1.10). After TSA, the evidence accumulated was far below the optimal information size. The heterogeneity of studies was high and methodological quality of most RCTs included in the meta-analysis was uncertain. Conclusions: Results of this meta-analysis show the data present in the literature are not sufficiently robust and, therefore, the use of topical ß-lactams or aminoglycosides before incision closure to reduce SSI cannot be recommended or excluded.

A Meta-analysis of Prophylaxis of Surgical Site Infections with Topical Application of Povidone Iodine Before Primary Closure.

BACKGROUND: Povidone iodine (PVI) is a widely used antiseptic solution among surgeons. A meta-analysis based on randomized controlled trials (RCTs) was conducted to establish whether application of PVI before wound closure could reduce surgical site infection (SSI) rates. METHODS: Systematic review of MEDLINE/PubMed, Scopus, CINAHL, and Web of Science databases from inception to September 2017, with no language restrictions. Only RCTs were retrieved. The primary outcome was the SSI rate. Meta-analysis was complemented with trial sequential analysis (TSA). RESULTS: A total of 7601 patients collected from 16 RCTs were analyzed. A reduction in overall SSI rate was found (RR 0.64, 95% CI 0.48-0.85, P = 0.002, I2 = 65%), which was attributed to patients undergoing elective operations (n = 2358) and mixed elective/urgent operations (n = 2019). When RCTs of uncertain quality (n = 9) were excluded, the use of PVI before wound closure (n = 4322 patients) was not associated with a significant reduction of SSI (RR 0.81, 95% CI 0.55-1.20, P = 0.29, I2 = 51%) and was only significant in clean wounds (RR 0.25, 95% CI 0.09-0.70, P = 0.008, I2 = 0%). For the primary outcome, the TSA calculation using a relative risk reduction of 19% and an 11% proportion of control event rate (CER) with 51% of I2, the accrued information size (n = 4322) was 32.8% of the estimated optimal information size (n = 13,148). CONCLUSIONS: There is no conclusive evidence for a strong recommendation of topical PVI before wound closure to prevent SSI.

Balancing mesh-related complications and benefits in primary ventral and incisional hernia surgery. A meta-analysis and trial sequential analysis.

BACKGROUND: Primary ventral hernia (PVH) and incisional hernia (IH) repair using a mesh appears to reduce hernia recurrence. However, are the benefits of mesh offset in part by mesh-related complications? The aim of this study was to compare placement of a mesh versus simple suture for recurrence and postoperative complications in the repair of PVH or IH. METHODS: Five databases were searched for randomized controlled trials (RCTs). The study population was patients with a PVH or IH undergoing hernia repair. Intervention was placement of a nonabsorbable synthetic mesh, regardless of mesh location, surgical technique, hernia characteristics or surgical setting compared to primary suture. Primary outcome was the incidence of hernia recurrence. Secondary outcomes were wound infection, hematoma, seroma, postsurgical pain, duration of operation, and quality of life. A random-effects meta-analysis with trial sequential analysis (TSA) was used. RESULTS: 10 RCTs with a total of 1270 patients were included. A significant reduction of the incidence of PVH or IH recurrence using a mesh for repair (risk ratio [RR] 0.39, 95% CI 0.27-0.55; P < 0.00001; I2 = 20%) was observed. TSA for recurrence, the accrued information size (1270) was 312% of the estimated required information size (RIS). Subgroup analysis for PVH and IH confirms reduction of recurrence after using a mesh in both groups. Overall postoperative complications did not show statistically significant differences between the mesh and surgical suture groups (RR 1.31, 95% CI 0.94-1.84; P = 0.12; I2 = 27%) but the accrued information size was only 22.4% of RIS and by subgroups complications were only related with IH repair. CONCLUSIONS: Evidence for the efficacy of repair of PVH or IH using a nonabsorbable synthetic mesh in terms of recurrence was found to be robust. Evidence for complications remains inconclusive.

Una malla profiláctica funciona en la prevención de la hernia paraestomal / To Prevent Parastomal Hernia After Stomal Surgery, a Prophylactic Mesh does Work

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Factors associated with low anterior resection syndrome after surgical treatment of rectal cancer.

AIM: To assess factors independently associated with low anterior resection syndrome (LARS) following resection or rectal cancer. METHOD: Cross-sectional study carried out in two acute-care teaching hospitals in Barcelona, Spain. Patients who had undergone sphincter preserving low anterior resection with curative intent, with total or partial mesorectal excision (with and without protective ileostomy) between January 2001 and December 2009 completed a self-administered questionnaire to assess bowel dysfunction after rectal cancer surgery. Predictors of LARS were assessed by univariate and multivariate analyses. RESULTS: The questionnaire was sent to 329 patients (response rate 57.7%). Six cases of incomplete questionnaires were excluded. The study population included 184 patients (66.8% men) with a mean age of 63 years. There were 44 (23.9%) patients with no LARS, 36 (19.6%) with minor LARS and 104 (56.2%) with major LARS. In the univariate analysis, total mesorectal excision (P = 0.0008), protective ileostomy (P = 0.002), preoperative and postoperative radiotherapy (P = 0.0000), postoperative chemotherapy (P = 0.0046) and age (P = 0.035) were significantly associated with major LARS, whereas in the multivariate analysis, total mesorectal excision (odds ratio [OR] 2.18, 95% confidence interval [CI] 1.02-4.65), preoperative radiotherapy (OR 4.33, 95% CI 2.03-9.27) and postoperative radiotherapy (OR 9.52, 95% CI 1.74-52.24) were independent risk factors for major LARS. CONCLUSIONS: In this study, the risk of having major LARS increases with total mesorectal excision and both neoadjuvant and adjuvant radiotherapy. This article is protected by copyright. All rights reserved.

Complex Abdominal Wall Hernia Repair in Contaminated Surgical Fields: Factors Affecting the Choice of Prosthesis.

To compare patients with complex abdominal wall hernias undergoing surgical repair using synthetic nonabsorbable or biologic meshes in contaminated fields. Retrospective review of 62 patients with complex abdominal wall hernia with surgical repair in an elective setting and in the context of a clean-contaminated or contaminated fields (January 2009-April 2015). Two groups according to the prosthesis (synthetic nonabsorbable, n = 48 or biologic, n = 14). Mean follow-up was 24.6 (15.8) months. Clean-contaminated wounds were significantly more frequent in the synthetic group. Contaminated wounds were significantly more frequent in the biologic group. Enterocutaneous fistula, recurrent hernia, and removal of chronic infected mesh were significantly more frequently in the biologic group. Differences in postoperative complications and surgical site infections were not found. Recurrence was higher in the biologic group (35.7% vs 8.3%, P = 0.03). In the elective repair of complex hernia, the level of contamination, a recurrent hernia, an enterocutaneous fistula or removal of chronic infected mesh were the factors affecting the choice of prosthesis. In the clean-contaminated setting, the use of a synthetic nonabsorbable mesh versus a biologic mesh did not increase the rate of postoperative infections. Recurrences are significantly higher with biologic meshes.

Preventing Parastomal Hernia Using a Modified Sugarbaker Technique With Composite Mesh During Laparoscopic Abdominoperineal Resection: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to assess the reduction in the incidence of parastomal hernia (PH) after placement of prophylactic synthetic mesh using a modified Sugarbaker technique when a permanent end-colostomy is needed. SUMMARY OF BACKGROUND DATA: Prevention of PH formation is crucial given the high prevalence of PH and difficulties in the surgical repair of PH. METHODS: A randomized, prospective, double-blind, and controlled trial. Rectal cancer patients undergoing laparoscopic abdominoperineal resection with permanent colostomy were randomized (1 : 1) to the mesh and nonmesh arms. In the mesh group, a large-pore lightweight composite mesh was placed in the intraperitoneal/onlay fashion using a modified Sugarbaker technique. PH was detected by computed tomography (CT) after a minimum follow-up of 12 months. Analysis was per-protocol. RESULTS: The mesh group included 24 patients and the control group 28. Preoperative data, surgical time, and postoperative morbidity were similar. The median follow-up was 26 months. After CT examination, 6 of 24 PHs (25%) were observed in the mesh group compared with 18 of 28 (64.3%) in the nonmesh group (odds ratio 0.39, 95% confidence interval 0.18-0.82; P = 0.005). The Kaplan-Meier curves showed significant differences in favor of the mesh group (long-rank = 4.21, P = 0.04). The number needed to treat was 2.5, which confirmed the effectiveness of the intervention. CONCLUSIONS: Placement of a prosthetic mesh by the laparoscopic approach following the modified Sugarbaker technique is safe and effective in the prevention of PH, reducing significantly the incidence of PH.

Low anterior resection syndrome: a survey of the members of the American Society of Colon and Rectal Surgeons (ASCRS), the Spanish Association of Surgeons (AEC), and the Spanish Society of Coloproctology (AECP).

BACKGROUND: Low anterior resection syndrome (LARS) is frequent following sphincter-sparing procedures for rectal cancer. OBJECTIVE: This study aims to assess surgeons' awareness of LARS. DESIGN: This was a survey study. SETTINGS: Members of the American Society of Colon and Rectal Surgeons (ASCRS), the Spanish Association of Surgeons (AEC), and the Spanish Society of Coloproctology (AECP). PARTICIPANTS: Three hundred thirty-four surgeons from the ASCRS and 150 from the Spanish Societies completed a 23-item electronic questionnaire. MAIN OUTCOME MEASURES: Surgeons' opinions regarding different aspects of LARS. RESULTS: The proportion of rectal cancer patients undergoing sphincter-sparing operations ranged between 71 and 90 %. Low anterior resection with end-to-end anastomosis was the most frequently cited procedure after mesorectal excision. More than 80 % of participants were recognized to be moderately or extremely aware of the condition, but regarding the method used to assess LARS, the majority relied on clinical manifestations. Around 35 % of surgeons considered that severe LARS developed in less than 40 % of patients. The most important factor related to defecatory function impairment in the surgeons' opinion was the distance from the anal margin to anastomosis. Other factors thought to be involved were anastomotic leakage, preoperative radiation therapy, age, and postoperative radiotherapy, with similar percentages in the two groups of surgeons. Lifestyle changes and dietary measures associated with or without drug treatment was the modality of choice. The experience with transanal irrigation or sacral nerve stimulation was limited. It was considered that <30 % of patients chronically suffer from severe LARS with significant quality of life impairment. LIMITATIONS: The limitations of this study are the international mix and expert status of the specialists. CONCLUSIONS: The probability of patients suffering from LARS was underestimated despite reporting good knowledge of the syndrome. Validated methods for the assessment of LARS were rarely used. Deficient awareness regarding risk factors for LARS was documented. Knowledge of therapeutic options was also limited.

PREBIOUS trial: a multicenter randomized controlled trial of PREventive midline laparotomy closure with a BIOabsorbable mesh for the prevention of incisional hernia: rationale and design.

BACKGROUND: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which is to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure. METHODS: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W.L. Gore & Associates, Flagstaff, AZ, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months. OUTCOMES: The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.

Cierre de la pared abdominal después del cierre de un estoma temporal / Abdominal wall closure after a stomal reversal procedure

Revertir un estoma temporal implica 2 procedimientos quirúrgicos diferentes: la reconstrucción del tránsito intestinal y el cierre de la pared abdominal en el sitio del estoma. Este último presenta diferentes aspectos que deben ser analizados: a) la infección del sitio quirúrgico (ISQ), b) el manejo de una hernia coincidente en el sitio del estoma en el momento de su cierre, c) la prevención del desarrollo de una hernia incisional posterior, d) el cierre del estoma en el caso de que se realice la reconstrucción del tránsito por vía laparoscópica, o e) el cierre de la piel del sitio del estoma. El objetivo de este trabajo es analizar estos aspectos en relación con la reconstrucción de la pared abdominal por la que emerge un estoma temporal cuando se procede al cierre de este

The closure of a temporary stoma involves 2 different surgical procedures: the stoma reversal procedure and the abdominal wall reconstruction of the stoma site The management of the abdominal wall has different areas that should be analyzed such us how to avoid surgical site infection (SSI), the technique to be used in case of a concomitant hernia at the stoma site or to prevent an incisional hernia in the future, how to deal with the incision when the stoma reversal procedure is performed by laparoscopy and how to close the skin at the stoma site. The aim of this paper is to analyze these aspects in relation to abdominal wall reconstruction during a stoma reversal procedure

Laparoscopy-assisted versus open colectomy for treatment of colon cancer in the elderly: morbidity and mortality outcomes in 545 patients.

BACKGROUND: Advanced age is a risk factor of major abdominal surgery due to diminished functional reserve and increased comorbidity. Laparoscopy-assisted colectomy is a well-established procedure in colon cancer surgery. The aim of this study was to compare early outcome of elective laparoscopy surgery and open colectomy in colon cancer patients according to age. METHODS: A total of 545 patients with colonic adenocarcinoma underwent elective surgery between 2005 and 2009. There were 277 patients in the laparoscopic group and 268 in the open. Patient characteristics in both groups were homogeneous and further stratified into three subgroups by age: <75, between 75-84, and ≥ 85 years. Main outcome measures were early morbidity, mortality, and hospital stay. RESULTS: Open surgery group showed a higher overall morbidity rate (37.3 vs. 21.6%, P = 0.001), medical complications (16.4 vs. 10.5%, P = 0.033), surgical complications (23.5 vs. 15.5%, P = 0.034), and mortality (6.7 vs. 3.2%, P = 0.034). The overall morbidity rate difference between open and laparoscopy approach disappeared in the oldest group (≥ 85 years old). Surgical site infections rate was inferior for patients <75 years old in laparoscopy group compared with open. Mortality was also significantly inferior in laparoscopy group in younger patients (<75 years, 0 vs. 3%, P = 0.038). Mean hospital stay was shorter for patients in <75 and 75-84 groups with laparoscopic approach (7.8 vs. 11.4 days and 10 vs. 14.3, respectively, P = 0.001) as compared with those who underwent open surgery, but these differences disappeared in patients aged ≥ 85 years. CONCLUSION: Laparoscopy-assisted colectomy in patients underwent elective surgical resections for colon cancer showed advantages in rate of early complications in patients younger than 85 years of age and was found to be as safe and well tolerated as open surgery in patients over 85 years of age.

Abdominal wall closure after a stomal reversal procedure.

The closure of a temporary stoma involves 2 different surgical procedures: the stoma reversal procedure and the abdominal wall reconstruction of the stoma site. The management of the abdominal wall has different areas that should be analyzed such us how to avoid surgical site infection (SSI), the technique to be used in case of a concomitant hernia at the stoma site or to prevent an incisional hernia in the future, how to deal with the incision when the stoma reversal procedure is performed by laparoscopy and how to close the skin at the stoma site. The aim of this paper is to analyze these aspects in relation to abdominal wall reconstruction during a stoma reversal procedure.

Evolución del cierre de ileostomía en una unidad de cirugía colorrectal. Análisis comparativo según la técnica / Ileostomy closure in a colorectal surgery unit. Comparative analysis of different techniques

INTRODUCCIÓN: El objetivo de este trabajo es valorar si los resultados del cierre de ileostomía en asa en términos de morbimortalidad y estancia hospitalaria se ven influidos por el tipo de anastomosis y de sutura empleada. MÉTODO: Se ha revisado el grupo de pacientes intervenidos por cierre de ileostomía en asa, y se ha realizado un análisis retrospectivo de cohortes comparando la morbimortalidad y estancia hospitalaria en función del tipo de anastomosis (TT o LL) y del tipo de sutura (manual/mecánica). RESULTADOS: Desde enero del 2003 a noviembre del 2011 se han analizado 167 procedimientos de reconstrucción del tránsito en ileostomía en asa. La distribución por grupos fue: tipo de anastomosis (TT 95; LL 72) y tipo de sutura (manual 105; mecánica 62). En el 76% de la población observada la enfermedad de base fue de origen oncológico. La mortalidad ha sido de un caso. El análisis de morbilidad estratificado por tipo de complicaciones no mostró diferencias significativas entre los grupos en cuanto a complicaciones locales (TT 7,4%; LL 8,3%; manual 6,7%; mecánica 9,7%), generales (TT 9,5%; LL 16,7%; manual 6,7%; mecánica 6,5%) y quirúrgicas (TT 15,8%; LL 19,4%; manual 17,1%; mecánica 17,7%), ni en el índice de reintervención (TT 6,3%; LL 6,9%; manual 6,7%; mecánica 6,5%) ni estancia hospitalaria expresada en días (TT 7,8; LL 8; manual 8,6; mecánica 6,7). CONCLUSIONES: La reconstrucción del tránsito intestinal en las ileostomías en asa puede realizarse independientemente del tipo de anastomosis y de sutura empleadas, con la misma tasa de morbimortalidad y estancia hospitalaria

INTRODUCTION: The objective of this study is to assess whether the results of loop ileostomy closure in terms of morbidity and hospital stay are influenced by the type of anastomosis and suture used. METHOD: All patients who underwent loop ileostomy closure were reviewed. A retrospective cohort study comparing morbidity and hospital stay according to the type of anastomosis (TT/LL) and the type of suture (hand sewn/mechanical) was performed. RESULTS: From January 2003 to November 2011 a total of 167 loop ileostomy closures were analized. The groups were: type of anastomosis (TT 95/LL 72) and type of suture (manual 105/stapled 62). In 76% of the observed population the underlying disease was cancer. Mortality occurred in one case. The stratified morbidity analysis by type of complications showed no significant differences between the groups in terms of local (7.4% TT, LL 8.3%, 6.7% hand sewn, stapled 9.7%), general (TT 9.5%, 16.7% LL, hand sewn 6.7%, 6.5% stapled) and surgical (TT 15.8%, 19.4% LL, hand sewn 17.1%, 17.7% stapled) complications, nor in the rate of reoperations (TT 6.3%, 6.9% LL, hand sewn 6.7%, 6.5% stapled) and hospital stay in days (TT 7.8, 8 LL, hand sewn 8.6, stapled 6.7). CONCLUSIONS: Closure of loop ileostomy can be performed regardless of the type of suture or anastomosis used, with the same rate of morbidity and hospital stay

[Ileostomy closure in a colorectal surgery unit. Comparative analysis of different techniques]. / Evolución del cierre de ileostomía en una unidad de cirugía colorrectal. Análisis comparativo según la técnica.

INTRODUCTION: The objective of this study is to assess whether the results of loop ileostomy closure in terms of morbidity and hospital stay are influenced by the type of anastomosis and suture used. METHOD: All patients who underwent loop ileostomy closure were reviewed. A retrospective cohort study comparing morbidity and hospital stay according to the type of anastomosis (TT/LL) and the type of suture (hand sewn/mechanical) was performed. RESULTS: From January 2003 to November 2011 a total of 167 loop ileostomy closures were analized. The groups were: type of anastomosis (TT 95/LL 72) and type of suture (manual 105/stapled 62). In 76% of the observed population the underlying disease was cancer. Mortality occurred in one case. The stratified morbidity analysis by type of complications showed no significant differences between the groups in terms of local (7.4% TT, LL 8.3%, 6.7% hand sewn, stapled 9.7%), general (TT 9.5%, 16.7% LL, hand sewn 6.7%, 6.5% stapled) and surgical (TT 15.8%, 19.4% LL, hand sewn 17.1%, 17.7% stapled) complications, nor in the rate of reoperations (TT 6.3%, 6.9% LL, hand sewn 6.7%, 6.5% stapled) and hospital stay in days (TT 7.8, 8 LL, hand sewn 8.6, stapled 6.7) CONCLUSIONS: Closure of loop ileostomy can be performed regardless of the type of suture or anastomosis used, with the same rate of morbidity and hospital stay.