PREVENTIO

• Conditions: Colonic diverticular bleeding

• Registration Number: NL-OMON29193
• Lead Sponsor: ot applicable

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 260

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.