The Role of Biofeedback in Improving Continence After Anterior Resection

Sponsor
University of Southampton (Other)
Overall Status
Completed
CT.gov ID
NCT00515853
Collaborator
(none)
121
1
2
41.5
2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Biofeedback
N/A

Detailed Description

See above

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Role of Biofeedback in Improving Continence After Anterior Resection
Actual Study Start Date :
Nov 27, 2006
Actual Primary Completion Date :
May 13, 2010
Actual Study Completion Date :
May 13, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biofeedback

Received feedback

Behavioral: Biofeedback
Biofeedback sessions or biofeedback exercises

No Intervention: No biofeedback

Did not received feedback

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Rectosigmoid or rectal cancer
Exclusion Criteria:
  • Inoperable

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southampton General Hospital Southampton Hampshire United Kingdom SO16 6YD

Sponsors and Collaborators

  • University of Southampton

Investigators

  • Principal Investigator: S A Pilkington, Southampton University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southampton
ClinicalTrials.gov Identifier:
NCT00515853
Other Study ID Numbers:
  • RHM GSU 0132
First Posted:
Aug 14, 2007
Last Update Posted:
Mar 7, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Southampton
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Biofeedback No Biofeedback
Arm/Group Description Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises Did not received feedback
Period Title: Overall Study
STARTED 61 60
COMPLETED 46 43
NOT COMPLETED 15 17

Baseline Characteristics

Arm/Group Title Biofeedback No Biofeedback Total
Arm/Group Description Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises Did not received feedback Total of all reporting groups
Overall Participants 61 60 121
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
69
(10)
66
(9)
67
(10)
Sex: Female, Male (Count of Participants)
Female
23
37.7%
27
45%
50
41.3%
Male
38
62.3%
33
55%
71
58.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
United Kingdom
61
100%
60
100%
121
100%
Incontinence (CCI) score (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
4
(5)
4
(5)
4
(5)

Outcome Measures

1. Primary Outcome
Title Cleveland Clinic Incontinence (CCI) Score
Description 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.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
Analyzed participants, less than the randomized participants
Arm/Group Title Biofeedback No Biofeedback
Arm/Group Description Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises Did not received feedback
Measure Participants 43 46
CCI final
4.2
(4.2)
3.7
(3.5)
Adjusted CCI final
1.2
(6.0)
-0.7
(5.5)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Biofeedback, No Biofeedback
Comments CCI final
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.54
Comments
Method Regression, Linear
Comments

Adverse Events

Time Frame 1 year
Adverse Event Reporting Description
Arm/Group Title Biofeedback No Biofeedback
Arm/Group Description Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises Did not received feedback
All Cause Mortality
Biofeedback No Biofeedback
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/61 (1.6%) 4/60 (6.7%)
Serious Adverse Events
Biofeedback No Biofeedback
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 5/61 (8.2%) 7/60 (11.7%)
Gastrointestinal disorders
Rectovaginal fistula 0/61 (0%) 0 1/60 (1.7%) 1
Surgical and medical procedures
Abdominoperineal excision 2/61 (3.3%) 2 2/60 (3.3%) 2
Hartman procedures 3/61 (4.9%) 3 4/60 (6.7%) 4
Other (Not Including Serious) Adverse Events
Biofeedback No Biofeedback
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/61 (0%) 0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Sophie A. Pilkington
Organization University of Southampton
Phone +44 (0)23 8059 5058
Email rgioinfo@soton.ac.uk
Responsible Party:
University of Southampton
ClinicalTrials.gov Identifier:
NCT00515853
Other Study ID Numbers:
  • RHM GSU 0132
First Posted:
Aug 14, 2007
Last Update Posted:
Mar 7, 2022
Last Verified:
Jan 1, 2022