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| [ Print-friendly version ] |
| A prospective double-blind multi-centre trial: laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis |
| ISRCTN | ISRCTN43911188 |
| ClinicalTrials.gov identifier | |
| Public title | A prospective double-blind multi-centre trial: laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis |
| Scientific title | |
| Acronym | Sigma-trial |
| Serial number at source | NTR928 |
| Study hypothesis | That the laparoscopic approach should be preferred over the open procedure in cases of an elective sigmoid resection for symptomatic diverticulitis. |
| Ethics approval | Approval received from the medical ethics committee of the VU Medical Centre on the 19th September 2003 (ref: 2003/109) |
| Study design | Randomised, double blinded, active controlled, parallel group, multicentre trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Diverticulitis, sigmoid resection |
| Participants - 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 less than 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 diverticulitis 3. The diagnosis diverticulitis is confirmed by computed tomography (CT)-scan and/or barium enema and coloscopy 4. Operation will take place at least after three months of the last attack of diverticulitis |
| Participants - exclusion criteria |
1. Signs of acute diverticulitis
2. Previous infra-umbilical laparotomy 3. Previous colorectal surgery 4. No informed consent |
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 01/01/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 104 |
| Interventions |
Open or laparoscopic sigmoid resection for diverticulitis.
Data is collected at the following times: 1. Pre-operative at the outpatient clinic: 36-item Short Form Health Survey (SF-36), Visual Analogue Scale (VAS)-pain score, medication, history and medical workup concerning diverticulitis 2. Peri-operative data (operating time, blood loss, conversion, etc.) 3. Post-operatively, there are short term data and long term data: 3.1. Short term: return to diet, minor and major complications (primary endpoint), pain, analgesics; all during hospital stay 3.2. Long term follow up, we see patients at the outpatient clinic at six weeks and six months post operative. They fill out an SF-36 questionnaire (general health) and VAS-pain score; we note late complications and use of analgesics. |
| Primary outcome measure(s) |
1. Morbidity (measured post-operatively)
2. Mortality (measured post-operatively) 3. Hospital stay (measured post-operatively) 4. Conversion rate (measured peri-operatively) |
| Secondary outcome measure(s) |
1. Operating time (measured peri-operatively)
2. Blood loss (measured peri-operatively) 3. Pain score (VAS) (measured pre-operatively, post-operatively and at six weeks and six months post-operatively) 4. Return to normal diet (post-operatively) 5. Use of analgesics (post-operatively and at six weeks and six months post-operatively) 6. General health (SF-36) (measured pre-operatively, post-operatively and at six weeks and six months post-operatively) |
| Sources of funding | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Trial website | http://www.sigmatrial.nl |
| Publications |
1. Protocol: http://www.ncbi.nlm.nih.gov/pubmed/17683563
2. 2009 results: http://www.ncbi.nlm.nih.gov/pubmed/19106674 |
| Contact name | Dr M A Cuesta |
| Address |
Vrije Universiteit Medical Centre (VUMC)
Department of Surgery P.O. Box 7057 |
| City/town | Amsterdam |
| Zip/Postcode | 1007 MB |
| Country | Netherlands |
| Tel | +31 (0)20 444 4444 (pager 6250) |
| ma.cuesta@vumc.nl | |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Address |
Department of Surgery
P.O. Box 7057 |
| City/town | Amsterdam |
| Zip/Postcode | 1007 MB |
| Country | Netherlands |
| Sponsor website: | http://www.vumc.nl/english/#http://www.vumc.nl/english/ |
| Date applied | 11/04/2007 |
| Last edited | 05/01/2009 |
| Date ISRCTN assigned | 11/04/2007 |
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