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
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
-
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.
-
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.