To evaluate the efficacy of laxatives (polyethylene glycol) versus supplementation of fibers on the incidence of rebleeding in patients hospitalized for colonic diverticular bleeding.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the difference in incidence of rebleeding
measured by preformatted questionnaire and clinical data between the
polyethylene glycol vs psyllium fiber group.
Secondary outcome
The secondary endpoints of the study are the 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 a previous studies showed 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.
Study objective
To evaluate the efficacy of laxatives (polyethylene glycol) versus
supplementation of fibers on the incidence of rebleeding in patients
hospitalized for colonic diverticular bleeding.
Study design
Single-center, randomized clinical trial to evaluate the efficacy of
polyethylene glycol versus psyllium fiber twice daily on the incidence of
rebleeding in patients who have been hospitalized for bleeding diverticular
disease. During the follow-up, the physician might adjust the dosage of
polyethylene glycol or psyllium fiber based on stool frequency and consistency.
Intervention
Group A: polyethylene glycol (OTC) twice daily, for the period of 12 weeks.
Group B: psyllium fiber (OTC) twice daily, for the period of 12 weeks.
Study burden and risks
Subjects will be asked to fill out the above mentioned questionnaires as
indicated by the table of assessments at the start of the study and at each
regular outpatient clinic visit at 6 and 12 weeks. Furthermore, daily practice
laboratory assessments will be collected during the study, as being part of the
regular outpatient clinic visits of the patients. Polyethylene glycol and
psyllium fiber have few side effects, if they occur tend to be mild.
Hilvarenbeekseweg 60 60
Tilburg Hilvarenbeekseweg 60
NL
Hilvarenbeekseweg 60 60
Tilburg Hilvarenbeekseweg 60
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71286.028.19 |