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A prospective double-blind multi-centre trial: Laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis (Sigma-trial).

A prospective double-blind multi-centre trial: Laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis (Sigma-trial).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25115
Enrollment
104
Registered
2007-03-11
Start date
2002-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Diverticulitis

Interventions

Open or laparoscopic sigmoid resection for diverticulitis.

Sponsors

VU medical center
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Signs of acute diverticulitis; 2. Previous infra umbilical laparotomy; 3. Previous colorectal surgery; 4. No informed consent.

Design outcomes

Primary

MeasureTime frame
1. Morbidity; 2. Mortality; 3. Hospital stay; 4. Conversion rate.

Secondary

MeasureTime frame
1. Operating time; 2. Blood loss; 3. Painscore; 4. Return to normal diet; 5. Use of analgetics; 6. General health (SF-36).

Contacts

Public ContactM.A. Cuesta

VU medical center Department of Surgery P.O. Box 7057

ma.cuesta@vumc.nl+31 (0)20 4444444 (pager 6250)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)