A prospective double-blind multi-centre trial: laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis
| ISRCTN | ISRCTN43911188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43911188 |
| Secondary identifying numbers | NTR928 |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 05/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M A Cuesta
Scientific
Scientific
Vrije Universiteit Medical Centre (VUMC)
Department of Surgery
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 4444 (pager 6250) |
|---|---|
| ma.cuesta@vumc.nl |
Study information
| Study design | Randomised, double blinded, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Sigma-trial |
| Study objectives | That the laparoscopic approach should be preferred over the open procedure in cases of an elective sigmoid resection for symptomatic diverticulitis. |
| Ethics approval(s) | Approval received from the medical ethics committee of the VU Medical Centre on the 19th September 2003 (ref: 2003/109) |
| Health condition(s) or problem(s) studied | Diverticulitis, sigmoid resection |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Morbidity (measured post-operatively) 2. Mortality (measured post-operatively) 3. Hospital stay (measured post-operatively) 4. Conversion rate (measured peri-operatively) |
| Secondary outcome measures | 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) |
| Overall study start date | 01/01/2002 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 104 |
| Key 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 |
| Key exclusion criteria | 1. Signs of acute diverticulitis 2. Previous infra-umbilical laparotomy 3. Previous colorectal surgery 4. No informed consent |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije Universiteit Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Website | http://www.vumc.nl/english/#http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Hospital/treatment centre
Vrije University Medical Centre (VUMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol: | 03/08/2007 | Yes | No | |
| Results article | results: | 01/01/2009 | Yes | No |
