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

NCT02136693 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2014-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Psyllium fiber

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Francesco Gabrielli

    lead OTHER

Principal Investigators

  • Francesco Gabrielli, Prof. · Università degli studi Milano Bicocca

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02136693 on ClinicalTrials.gov