NCT00515853

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2010

Completed
11.8 years until next milestone

Results Posted

Study results publicly available

March 7, 2022

Completed
Last Updated

March 7, 2022

Status Verified

January 1, 2022

Enrollment Period

3.5 years

First QC Date

August 10, 2007

Results QC Date

November 19, 2021

Last Update Submit

January 3, 2022

Conditions

Rectal NeoplasmsFecal IncontinenceAged

Keywords

Rectal neoplasmsBiofeedback (Psychology)Fecal IncontinenceAgedAnterior resection

Outcome Measures

Primary Outcomes (1)

  • Cleveland Clinic Incontinence (CCI) Score

    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.

    1 year

Study Arms (2)

Biofeedback

EXPERIMENTAL

Received feedback

Behavioral: Biofeedback

No biofeedback

NO INTERVENTION

Did not received feedback

Interventions

BiofeedbackBEHAVIORAL

Biofeedback sessions or biofeedback exercises

Biofeedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rectosigmoid or rectal cancer

You may not qualify if:

  • Inoperable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Rectal NeoplasmsFecal Incontinence

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Results Point of Contact

Title
Sophie A. Pilkington
Organization
University of Southampton
rgioinfo@soton.ac.uk
+44 (0)23 8059 5058

Study Officials

  • S A Pilkington

    Southampton University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2007

First Posted

August 14, 2007

Study Start

November 27, 2006

Primary Completion

May 13, 2010

Study Completion

May 13, 2010

Last Updated

March 7, 2022

Results First Posted

March 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)