The Role of Biofeedback in Improving Continence After Anterior Resection

NCT ID: NCT00515853

Last Updated: 2022-03-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-27

Study Completion Date

2010-05-13

Brief Summary

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

Detailed Description

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See above

Conditions

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Rectal Neoplasms Fecal Incontinence Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Biofeedback

Received feedback

Group Type EXPERIMENTAL

Biofeedback

Intervention Type BEHAVIORAL

Biofeedback sessions or biofeedback exercises

No biofeedback

Did not received feedback

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Biofeedback

Biofeedback sessions or biofeedback exercises

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Rectosigmoid or rectal cancer

Exclusion Criteria

* Inoperable
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S A Pilkington

Role: PRINCIPAL_INVESTIGATOR

Southampton University

Locations

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Southampton General Hospital

Southampton, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RHM GSU 0132

Identifier Type: -

Identifier Source: org_study_id

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