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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR928 |
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Date of registration:
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11/03/2007 |
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Primary sponsor: |
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Public title:
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A prospective double-blind multi-centre trial: Laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis (Sigma-trial).
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Scientific title:
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A prospective double-blind multi-centre trial: Laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis (Sigma-trial). - Sigma-trial |
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Date of first enrolment:
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1/1/2002 |
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Target sample size:
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104 |
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Recruitment status: |
other |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=928 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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B.R.
Klarenbeek |
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Address:
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, Bakkersteeg 11
2311 RH
Leiden
The Netherlands |
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Telephone:
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+31 (0)6 41254152 |
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Email:
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br.klarenbeek@vumc.nl |
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Affiliation:
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Name:
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M.A.
Cuesta |
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Address:
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VU medical center
Department of Surgery
P.O. Box 7057 , De Boelelaan 1117
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4444444 (pager 6250) |
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Email:
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ma.cuesta@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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 <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 diverticulits;
3. The diagnosis diverticulitis is confirmed by CT-scan and/or barium enema and coloscopy;
4. Operation will take place at least after three months of the last attack of diverticulitis.
Exclusion criteria: 1. Signs of acute diverticulitis;
2. Previous infra umbilical laparotomy;
3. Previous colorectal surgery;
4. No informed consent.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Diverticulitis, Sigmoid resection
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Intervention(s)
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Open or laparoscopic sigmoid resection for diverticulitis.
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Primary Outcome(s)
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1. Morbidity;
2. Mortality;
3. Hospital stay;
4. Conversion rate.
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Secondary Outcome(s)
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1. Operating time;
2. Blood loss;
3. Painscore;
4. Return to normal diet;
5. Use of analgetics;
6. General health (SF-36).
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Secondary ID(s)
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ISRCTN43911188
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Source(s) of Monetary Support
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VU University Medical Center, Department of Surgery
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