The Role of Biofeedback in Improving Continence After Anterior Resection

Not Applicable

Completed

• Conditions: Rectal Neoplasms; Fecal Incontinence; Aged
• Interventions: Behavioral: Biofeedback

• Registration Number: NCT00515853
• Lead Sponsor: University of Southampton

Brief Summary

The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.

Detailed Description

See above

Study Timeline

• Study Start: 2006-11-27
• Study First Submitted: 2007-08-10
• Study First Submitted QC: 2007-08-10
• Study First Posted: 2007-08-14
• Primary Completion: 2010-05-13
• Study Completion: 2010-05-13
• Results First Submitted: 2021-11-19
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-03
• Last Update Submitted: 2022-01-03
• Results First Posted: 2022-03-07
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Rectosigmoid or rectal cancer

Exclusion Criteria

• Inoperable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback	Biofeedback	Received feedback

Primary Outcome Measures

Name	Time	Method
Cleveland Clinic Incontinence (CCI) Score	1 year	The Cleveland Clinic incontinence score (CCI) is an anal incontinence severity score. It is easy to use and gives the patient a score of 0 to 20, where zero equates to perfect continence and twenty equates to complete anal incontinence.

Trial Locations

Locations (1)

Southampton General Hospital; 🇬🇧 Southampton, Hampshire, United Kingdom