title: Laparoscopic versus open sigmoid resection for diverticular disease: follow-up assessment of the randomized control Sigma trial.
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.
authors.affiliation: Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.
authors.forename: Bastiaan R
authors.initials: BR
authors.lastname: Klarenbeek
authors.forename: Roberto
authors.initials: R
authors.lastname: Bergamaschi
authors.forename: Alexander A F A
authors.initials: AA
authors.lastname: Veenhof
authors.forename: Donald L
authors.initials: DL
authors.lastname: van der Peet
authors.forename: Wim T
authors.initials: WT
authors.lastname: van den Broek
authors.forename: Elly S M
authors.initials: ES
authors.lastname: de Lange
authors.forename: Willem A
authors.initials: WA
authors.lastname: Bemelman
authors.forename: Pieter
authors.initials: P
authors.lastname: Heres
authors.forename: Antonio M
authors.initials: AM
authors.lastname: Lacy
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Cuesta
mesh_terms: D015897:Comorbidity; D004239:Diverticulitis, Colonic / Q000601:surgery*; D043963:Diverticulosis, Colonic / Q000601:surgery*; D004311:Double-Blind Method; D017558:Elective Surgical Procedures / Q000706:statistics & numerical data; D005500:Follow-Up Studies; D006801:Humans; D007081:Ileostomy / Q000379:methods; D010535:Laparoscopy / Q000379:methods* / Q000706:statistics & numerical data; D007813:Laparotomy / Q000379:methods / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology / Q000601:surgery; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012008:Recurrence; D012810:Sigmoid Diseases / Q000601:surgery*; D013997:Time Factors