The objective is to compare the outcome of elective surgery to conservative management for patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis (within one year).
ID
Source
Brief title
Condition
- Diverticular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life measured by the Gastro-intestinal Quality of Life Index,
Shortform-36, EuroQol-5D, ROME III vragenlijst and VAS.
Secondary outcome
- 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.
Background summary
Persisting abdominal complaints are common after an episode of diverticulitis
treated conservatively. Furthermore, some patients develop diverticulitis
recurrences within a year These two groups of patients suffer greatly from
their disease impairing quality of life and increasing costs due to multiple
specialist consultations, pain medication and sick-leave from paid work.
Both conservative and operative management of patients with persisting
abdominal complaints after an episode of diverticulitis and/or frequently
recurring diverticulitis (within one year) are applied. However, direct
comparison by a randomised controlled trial is necessary to determine which is
superior in relieving symptoms, optimalising QoL, minimising costs and
preventing diverticulitis recurrences against acceptable morbidity and
mortality associated with surgery or the occurrence of a complicated recurrence
after conservative management.
We, therefore, constructed a randomised clinical trial comparing these two
treatment strategies.
Study objective
The objective is to compare the outcome of elective surgery to conservative
management for patients with persisting abdominal complaints after an episode
of diverticulitis and/or frequently recurring diverticulitis (within one year).
Study design
Multicenter randomised clinical trial with a follow-up of 1 year.
Intervention
Patients randomised for conservative treatment are treated according to the
current daily practice (antibiotics, analgetics and/or expectant management).
Patients randomised for elective resection will undergo an elective resection
of the affected colon segment. Preferably, a laparoscopic approach is used.
Study burden and risks
Burdens:
- The filling out of the quality of life questionnaires. The filling out of
these surveys will take approximately (5x20) 150 minutes of the patient*s time.
- Patients are asked to revisit their local hospital to sign the informed
consent. Baseline data will also be collected. This will take 10 minutes.
- The possible, but unlikely, unfavorable outcome of elective resection.
- Randomisation may be a burden giving the fact that patients are subjected to
fate for treatment allocation.
Benefits:
The potential benefits of participation in this study for this specific group
of patients is a potential final answer to the discussion about the optimal
treatment for patients with persisting abdominal symptoms after a
diverticulitis episode treated conservatively.
The close follow-up regarding objective and subjective outcome of treatment in
the studied subjects is also likely to be beneficial.
Utrechtseweg 160
Amersfoort 3818 ES
NL
Utrechtseweg 160
Amersfoort 3818 ES
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24903.100.08 |