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
Protocol serial number	NTR928
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	Vrije University Medical Centre (VUMC) (The Netherlands)

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

Vrije Universiteit Medical Centre (VUMC)
Department of Surgery
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 4444 (pager 6250)
Email	ma.cuesta@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, double blinded, active controlled, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
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(s)	1. Morbidity (measured post-operatively) 2. Mortality (measured post-operatively) 3. Hospital stay (measured post-operatively) 4. Conversion rate (measured peri-operatively)
Key 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)
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results:	01/01/2009		Yes	No
Protocol article	Protocol:	03/08/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes