A Phase 4 interventional study of Psyllium fiber and Placebo in Constipation and Incontinence, sponsored by Francesco Gabrielli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-13.
Sponsored by Francesco Gabrielli · Phase 4, Interventional, and Prevention
This study aims to assess whether fiber intake, formerly recommended only before or instead of surgery, may play a role in improving postoperative progress and functional outcome after STARR for obstructed defecation, in terms of residual constipation, incontinence and defecation urgency.
After obtaining written informed consent and collecting baseline scores (T0), each patient was randomly assigned to one of the two groups and began taking sachets containing Psyllium fiber 3.5 g / day for Active group (A) and inert compound for Placebo group (P).
Sachet content was assigned by software randomization, written on a list and sealed in an envelope, which was opened only after the study was completed.
Post-operative instructions for both groups included only analgesic therapy (Ketorolac 10 to 30 mg b.m. if needed). Patients were also asked to stop any former laxative and to continue on a normal diet.
Each patient was re-evaluated at 7 ± 3 (T1), 60 ± 5 (T2) and 180 ± 15 (T3) days after surgery (Table 2).
A fluoroscopic colpocystodefecography (with patient sitting upright) was obtained before surgery and between 60-180 days postoperatively in order to assess comparability of the two groups and exclude negative organic outcomes that could affect functional results.
Medical events were investigated while checking each patient, with special regard to defecation urgency. From the data collected on concomitant medications, we extrapolated those related to laxative intake.
The treatment was considered accomplished in patients who had taken at least 70% of the product during each interval of follow-up.
Statistical analysis was performed using the SPSS - PASW Statistics 18.0.0 (IBM ©, 2009).
For the general and defecographic characteristics, the data are expressed in the form of mean ± standard deviation for continuous variables and absolute frequency (frequency percentages) for categorical variables. The differences between the two groups were calculated by two-tailed t-test or chi-square when appropriate.
Scores for the assessment of clinical data are expressed as mean ± standard deviation and analysis of the differences in the two groups was performed using the two-tailed t-test. The analysis of not normally distributed variables was conducted using a non-parametric test (Wilcoxon-Mann-Whitney).
Analyses related to defecation urgency and use of laxatives were carried out using chi-square test and the data are expressed as absolute frequency (frequency percentage).
For all tests, a value of p \<0.05 was considered significant.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 65 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →This is the only study on the registry with Francesco Gabrielli as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3.5 g /day of inert compound for 180 days after STARR
Drug: Placebo
3.5 g /day of pure Psyllium fiber for 180 days after STARR
Drug: Psyllium fiber
3.5 g /day of pure Psyllium fiber for 180 days after STARR
3.5 g /day of inert compound for 180 days after STARR
Also known as: inert compound
residual constipation
ODS score and CCS score
Time frame: 180 days after STARR
Post-operative pain
VAS
Time frame: 180 days after STARR
revertence to laxative use
frequency percentage of patients that reverted to laxative use after surgery
Time frame: 180 days after STARR
change in fecal incontinence from baseline
Wexner Incontinence score
Time frame: 180 days after STARR
post-operative defecation urgency
defecation urgency incidence
Time frame: 180 days after STARR
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.