No registrations found.
ID
Source
Brief title
Health condition
Colonic diverticular bleeding
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of the efficacy of polyethylene glycol versus psyllium fiber in a randomized controlled trial to prevent rebleeding and readmission in patients hospitalized for colonic diverticular bleeding.
Secondary outcome
Assessment of the effect of polyethylene glycol versus psyllium fiber on differences in quality of live indicated by the EuroQol questionnaire, stool frequency and -consistency measured by the Bristol Stool Scale, and diverticular disease activity measured by standard clinical and laboratory assessments.
Background summary
Colonic diverticular bleeding is one of the most common causes of lower gastrointestinal bleeding. The results of previous studies show that repeated rebleeding occurs in approximately 10 - 20% within the first year. No consensus exists as to the best treatment to prevent rebleeding. Treatment options range from lifestyle advise such as increased intake of dietary fiber, supplementation of fibers or laxatives.
This study aims to evaluate the efficacy of laxatives (polyethylene glycol) versus supplementation of fibers on the incidence of rebleeding in patients hospitalized for colonic diverticula bleeding.
Single-center, randomized clinical trial.
Study objective
Decreasing the intraluminal pressure has a inhibiting effect on the rebleeding incidence.
Study design
Screening period (-2 days, Visit 0), Week 0 (visit 1), Week 6 (Visit 2), Week 12 (visit 3).
Intervention
Polyethylene glycol or Psyllium fiber
Inclusion criteria
- Patients between the ages of 18 and 85 years old;
- Patients who are hospitalized for bleeding diverticular disease in the Elisabeth-Tweesteden Ziekenhuis (ETZ);
- Patients with diverticular disease based on colonoscopy <5 years.
Exclusion criteria
- Other bleeding diseases of the colon requiring medicinal treatment such as IBD or infection;
- Patients hypersensitive to macrogol or psyllium;
- 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9454 |
| CCMO | NL71286.028.19 |
| OMON | NL-OMON52735 |