diverticulitis inflammation of outpouchings in the colonic wall
Conditions
Interventions
Patients randomised for conservative treatment are treated according to the
current daily practice (antibiotics, analgetics and/or expectant management).
Patients randomised for elective resection w
Sponsors
Meander Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18-75 years. - A well documented (CT-scan, sonography or endoscopy) previous episode of diverticulitis. - Patients presenting with either persisting abdominal complaints and/or frequently recurring diverticulitis after an episode of diverticulitis. Persisting abdominal complaints may include patients with: - continuing lower left abdominal pain AND/OR persistent change in bowel habits AND/OR persistent blood loss. - Symptoms must exist longer than 3 months after a previous episode of diverticulitis. - Symptoms must be accompanied by changes in the colonic wall on a recent CT-scan, sonography or endoscopy. Frequently recurring diverticulitis is defined as: - A total of three or more in-hospital presentations for an episode of diverticulitis within 2 years. As described previously, (at least) one episode must be well documented (CT-scan, sonography or endoscopy). - A minimal interval of 3 months between the episodes is mandatory. - ASA I-III
Exclusion criteria
Exclusion criteria: - Patients with elective or emergency surgery for acute diverticulitis in the past. - Patients with an absolute operation indication (perforation with purulent/fecal peritonitis, symptomatic bowel stenosis or fistula). - Patients with colorectal malignancies. - Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests. - Patients in ASA class III who are at high risk for per- and postoperative complications due o severe co-morbidity as regarded by the surgeon and/or the patients specialists
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life measured by the Gastro-intestinal Quality of Life Index, Shortform-36, EuroQol-5D, ROME III vragenlijst and VAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mortality - Morbidity - Recurrence rate - Total in-hospital costs (including that of subsequents episodes), as well as costs related to sick leave from paid work and health care consumption. | — |
Countries
Netherlands
Outcome results
None listed