A randomized clinical trial to evaluate the efficacy of polyethylene glycol vs psyllium fiber to prevent rebleeding in patients hospitalized with bleeding diverticular disease.
- Conditions
- Bleeding Diverticular disease10017977
- Registration Number
- NL-OMON52735
- Lead Sponsor
- Elisabeth-Tweesteden ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 260
Patients between the ages of 18 or older.
Patients who are hospitalized for bleeding diverticular disease in het ETZ.
Patients with diverticular disease based on colonoscopy, sigmoïdscopy or
CT-scan <5 years
Other bleeding diseases of the colon requiring medicinal treatment such as IBD
or infection
Surgical treatment following initial episode of bleeding diverticular disease.
Patients using polyethylene glycol or psyllium fiber regularly, more than twice
daily.
Patients who are pregnant, lactating or planning pregnancy while enrolled in
the study.
Patients who are unsuitable for inclusion in the study in the opinion of the
investigator for any reason that may compromise the subject*s safety or
confound data interpretation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is the difference in incidence of rebleeding<br /><br>measured by preformatted questionnaire and clinical data between the<br /><br>polyethylene glycol vs psyllium fiber group.</p><br>
- Secondary Outcome Measures
Name Time Method <p> The secondary endpoints of the study are the differences in quality of live<br /><br>indicated by the EuroQol questionnaire, stool frequency and - consistency<br /><br>measured by the Bristol Stool Scale and diverticular disease activity measured<br /><br>by standard clinical and laboratory assessments. </p><br>