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Published in: Surgical Endoscopy 4/2011

01-04-2011

Laparoscopic versus open sigmoid resection for diverticular disease: follow-up assessment of the randomized control Sigma trial

Authors: Bastiaan R. Klarenbeek, Roberto Bergamaschi, Alexander A. F. A. Veenhof, Donald L. van der Peet, Wim T. van den Broek, Elly S. M. de Lange, Willem A. Bemelman, Pieter Heres, Antonio M. Lacy, Miguel A. Cuesta

Published in: Surgical Endoscopy | Issue 4/2011

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Abstract

Background

The short-term results of the Sigma trial show that laparoscopic sigmoid resection (LSR) used electively for diverticular disease offers advantages over open sigmoid resection (OSR). This study aimed to compare the overall mortality and morbidity rates after evaluation of the clinical outcomes at the 6-month follow-up evaluation.

Methods

In a prospective, multicenter, double-blind, parallel-arm, randomized control trial, eligible patients were randomized to either LSR or OSR. The short-term results and methodologic details have been published previously. Follow-up evaluation was performed at the outpatient clinic 6 weeks and 6 months after surgery.

Results

In this trial, 104 patients were randomized for either LSR or OSR, and the conversion rate was 19.2%. The LSR approach was associated with short-term benefits such as a 15.4% reduction in the major complications rate, less pain, and a shorter hospital stay at the cost of a longer operating time. At the 6-month follow-up evaluation, no significant differences in morbidity or mortality rates were found. Two patients died of cardiac causes (overall mortality, 3%). Late complications (7 LSR vs. 12 OSR; p = 0.205) consisted of three incisional hernias, five small bowel obstructions, four enterocutaneous fistulas, one intraabdominal abscess, one retained gauze, two anastomotic strictures, and three recurrent episodes of diverticulitis. Nine of these patients underwent additional surgical interventions. Consideration of the major morbidity over the total follow-up period (0–6 months) shows that the LSR patients experienced significantly fewer complications than the OSR patients (9 LSR vs. 23 OSR; p = 0.003). The Short Form-36 (SF-36) questionnaire showed significantly better quality of life for LSR at the 6-week follow-up assessment. However, at the 6-month follow-up assessment, these differences were decreased.

Conclusions

The late clinical outcomes did not differ between LSR and OSR during the 30-day to 6-month follow-up period. Consideration of total postoperative morbidity shows a 27% reduction in major morbidity for patients undergoing laparoscopic surgery for diverticular disease.
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Metadata
Title
Laparoscopic versus open sigmoid resection for diverticular disease: follow-up assessment of the randomized control Sigma trial
Authors
Bastiaan R. Klarenbeek
Roberto Bergamaschi
Alexander A. F. A. Veenhof
Donald L. van der Peet
Wim T. van den Broek
Elly S. M. de Lange
Willem A. Bemelman
Pieter Heres
Antonio M. Lacy
Miguel A. Cuesta
Publication date
01-04-2011
Publisher
Springer-Verlag
Published in
Surgical Endoscopy / Issue 4/2011
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-010-1327-0

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