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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Francesco Gabrielli
• Treatments: Calcium polycarbophil; Psyllium

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