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

Launched by FRANCESCO GABRIELLI · May 10, 2014

Keywords

ClinConnect Summary

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 co...

Gender

ALL

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