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DIRECT trial: Diverticulitis Recurrences or Continuing Symptoms Treatment, Operative versus Conservative. A MULTICENTER RANDOMISED CLINICAL TRIAL.

DIRECT trial: Diverticulitis Recurrences or Continuing Symptoms Treatment, Operative versus Conservative. A MULTICENTER RANDOMISED CLINICAL TRIAL.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26101
Enrollment
214
Registered
2008-09-20
Start date
2010-05-01
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

EN: Diverticulitis, recurrence, recurrences. NL: Diverticulitis, recidief, recidieven.

Interventions

Conservative treatment: Patients randomised for conservative treatment are treated according to the current daily practice. In other words, conservative treatment is determined by the preferences of

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years; 2. Patients presenting with either persisting abdominal complaints and/or frequently recurring diverticulitis after a well documented (CT-scan or sonography) episode of diverticulitis. Persisting abdominal complaints may include patients with: A. Continuing lower left abdominal pain AND/OR persistent change in bowel habits AND/OR persistent blood loss; B. Symptoms must exist longer than 3 months after a previous episode of diverticulitis. Frequently recurring diverticulitis is defined as: A. Three or more diverticulitis recurrences within 2 years; B. A minimal interval of 3 months between the recurrences is mandatory. 3. Persisting abdominal complaints and/or frequently recurring diverticulitis must be accompanied by inflammatory changes (CT-scan or sonography) in the bowel wall: Bowel-wall thickening with or without abscess; 4. ASA I -III.

Exclusion criteria

Exclusion criteria: 1. Patients with elective or emergency surgery for acute diverticulitis in the past; 2. Patients with an absolute operation indication (perforation with purulent/fecal peritonitis, symptomatic bowel stenosis or fistula); 3. Patients with colorectal malignancies; 4. Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests.

Design outcomes

Primary

MeasureTime frame
Quality of life (QoL) objectified primarily by the Gastro-intestinal Quality of life Index (GIQLI) and secondarily by EuroQol-5D (EQ-5D), Short-form 36 (SF-36) and Visual Analogue Score (VAS) for pain. Patients are also asked to point out on a 7 point scale whether their health/complaints have improved or deteriorated.

Secondary

MeasureTime frame
1. Mortality; 2. Morbidity; 3. (In)Direct (non-)health care costs.

Contacts

Public ContactWall, van de

Meander Medical Centre Amersfoort Department of Surgery Postbus 1502

BMJ.vande.Wall@meandermc.nl+31 (0)6 45772274

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)