Psyllium Fiber Versus Placebo in Early Treatment After STARR for Obstructed Defecation: a Double-blind RCT

NCT ID: NCT02136693

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Constipation; Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo

3.5 g /day of inert compound for 180 days after STARR

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3.5 g /day of inert compound for 180 days after STARR

Psyllium fiber

3.5 g /day of pure Psyllium fiber for 180 days after STARR

Group Type: EXPERIMENTAL

Psyllium fiber

Intervention Type: DRUG

3.5 g /day of pure Psyllium fiber for 180 days after STARR

Interventions

Psyllium fiber

3.5 g /day of pure Psyllium fiber for 180 days after STARR

Intervention Type: DRUG

Placebo

3.5 g /day of inert compound for 180 days after STARR

Intervention Type: DRUG

Other Intervention Names

inert compound

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Age over 18
• Diagnosis of Obstructed Defecation Syndrome according to ODS and CCS Score
• STARR performed when ODS score >10
• STARR performed 48-72 hours before

Exclusion Criteria

• Puborectalis or sphincter dyssynergia, evaluated by defecography and / or anorectal manometry
• Concomitant diseases (fissure, abscess, fistula, IBD, diverticular disease)
• Prolapse of other pelvic floor organs
• Proctological surgery before STARR
• Pregnancy or breast-feeding
• Ongoing treatment with oral anticoagulants or steroid therapy
• Conditions that do not allow patients to understand the nature and the purpose of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Francesco Gabrielli

OTHER

Sponsor Role: lead

Responsible Party

Francesco Gabrielli

professore ordinario di chirurgia generale

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francesco Gabrielli, Prof.

Role: STUDY_CHAIR

Università degli studi Milano Bicocca

Locations

Istituti Clinici Zucchi

Monza, MB, Italy

Countries

Italy

Other Identifiers

psyllium_STARR

Identifier Type: -

Identifier Source: org_study_id