Condition category
Surgery
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
05/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sigmatrial.nl

Contact information

Type

Scientific

Primary contact

Dr M A Cuesta

ORCID ID

Contact details

Vrije Universiteit Medical Centre (VUMC)
Department of Surgery
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 4444 (pager 6250)
ma.cuesta@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR928

Study information

Scientific title

Acronym

Sigma-trial

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2002

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

104

Participant exclusion criteria

1. Signs of acute diverticulitis
2. Previous infra-umbilical laparotomy
3. Previous colorectal surgery
4. No informed consent

Recruitment start date

01/01/2002

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije Universiteit Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Surgery
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/#http://www.vumc.nl/english/

Funders

Funder type

Hospital/treatment centre

Funder name

Vrije University Medical Centre (VUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Protocol: http://www.ncbi.nlm.nih.gov/pubmed/17683563
2. 2009 results: http://www.ncbi.nlm.nih.gov/pubmed/19106674

Publication citations

  1. Protocol

    Klarenbeek BR, Veenhof AA, de Lange ES, Bemelman WA, Bergamaschi R, Heres P, Lacy AM, van den Broek WT, van der Peet DL, Cuesta MA, The Sigma-trial protocol: a prospective double-blind multi-centre comparison of laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis., BMC Surg, 2007, 7, 16, doi: 10.1186/1471-2482-7-16.

  2. Results

    Klarenbeek BR, Veenhof AA, Bergamaschi R, van der Peet DL, van den Broek WT, de Lange ES, Bemelman WA, Heres P, Lacy AM, Engel AF, Cuesta MA, Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial: short-term results of the Sigma Trial., Ann. Surg., 2009, 249, 1, 39-44, doi: 10.1097/SLA.0b013e31818e416a.

Additional files

Editorial Notes