|- candidate number||2510|
|- NTR Number||NTR928|
|- Date ISRCTN created||11-apr-2007|
|- date ISRCTN requested||24-mrt-2007|
|- Date Registered NTR||11-mrt-2007|
|- Secondary IDs|| |
|- Public Title||A prospective double-blind multi-centre trial: Laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis (Sigma-trial).|
|- Scientific Title||A prospective double-blind multi-centre trial: Laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis (Sigma-trial).|
|- hypothesis||That the laparoscopic approach should be preferred over the open procedure in cases of an elective sigmoid resection for symptomatic diverticulitis.|
|- Healt Condition(s) or Problem(s) studied||Diverticulitis, Sigmoid resection|
|- Inclusion criteria||1. Patients who were admitted for a conservatively treated episode of diverticulitis, who will therefore undergo an elective resection of the sigmoid;|
2. The indication for elective resection is in patients <50 years after one episode of conservatively treated diverticulitis and in patients older than 50 years after two episodes of diverticulitis or in case of progressive abdominal complaints due to strictures caused by a previous episode of diverticulits;
3. The diagnosis diverticulitis is confirmed by CT-scan and/or barium enema and coloscopy;
4. Operation will take place at least after three months of the last attack of diverticulitis.
|- Exclusion criteria||1. Signs of acute diverticulitis;|
2. Previous infra umbilical laparotomy;
3. Previous colorectal surgery;
4. No informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2002|
|- planned closingdate||1-jan-2008|
|- Target number of participants||104|
|- Interventions||Open or laparoscopic sigmoid resection for diverticulitis.|
|- Primary outcome||1. Morbidity; |
3. Hospital stay;
4. Conversion rate.
|- Secondary outcome||1. Operating time;|
2. Blood loss;
4. Return to normal diet;
5. Use of analgetics;
6. General health (SF-36).
|- Trial web site||http://www.sigmatrial.nl|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. M.A. Cuesta|
|- CONTACT for SCIENTIFIC QUERIES||MD. B.R. Klarenbeek|
|- Sponsor/Initiator ||VU University Medical Center, Department of Surgery|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Department of Surgery|
|- Brief summary||Background:|
Diverticulosis is a common disease in the western society with an incidence of 33-66%. 10-25% of these patients will develop diverticulitis. In order to prevent a high-risk acute operation it is advised to perform elective sigmoid resection after two episodes of diverticulitis in the elderly patient or after one episode in the younger (< 50 years) patient. Open sigmoid resection is still the gold standard, but laparoscopic colon resections seem to have certain advantages over open procedures. On the other hand, a double blind investigation has never been performed.
Indication for elective resection is one episode of diverticulitis in patients < 50 years and two episodes in patient > 50 years or in case of progressive abdominal complaints due to strictures caused by a previous episode of diverticulits. The diagnosis is confirmed by CT-scan, barium enema and/or coloscopy.
It is required that the participating surgeons have performed at least 15 laparoscopic and open sigmoid resections. Open resection is performed by median laparotomy, laparoscopic resection is approached by 4 or 5 cannula. Sigmoid and colon which contain serosal changes or induration are removed and a tension free anastomosis is created. After completion of either surgical procedure an opaque dressing will be used, covering from 10 cm above the umbilicus to the pubic bone. Surgery details will be kept separate from the patientís notes.
Endpoints are morbidity and mortality, duration of the operation, blood loss and conversion percentage. Post operative recovery consists of return to normal diet, pain, analgesics, general health (SF-36 questionnaire) and duration of hospital stay.
The Sigma-trial is a prospective, multi-center, double-blind, randomized study to define the role of laparoscopic treatment in patients with symptomatic diverticulitis.
|- Main changes (audit trail)|
|- RECORD||11-mrt-2007 - 15-mei-2008|