An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients
February 2, 2015 updated by: Kye Bong-Hyeon, The Catholic University of Korea
A Randomised Controlled Trial for the Effect of Biofeedback Therapy for the Preveintion of Anterior Resection Syndrome in Rectal Cancer Patients Who Have Undergone Low Anterior Resection With Total Mesorectal Excision Following Neoadjuvant Chemoradiation Therapy
In patients who underwent sphincter preserving surgery with toal mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal function after stoma closure.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Suwon, Korea, Republic of, 442-723
- Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Rectal cancer patients who underwent sphincter saving surgery with total mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy.
Description
Inclusion Criteria:
- rectal cancer patients
- neoadjuvant chemoradiation therapy (+)
- sphincter saving surgery with total mesorectal excision (+)
- temporary loop stoma (+)
- adult who is 17 years or older
- patinet who aggree with our study
- if woman is childbearing age, her pregnancy test shoud be indentified 'negative'
Exclusion Criteria:
- patients who have been enrolled to other clinical studies related to this study
- patients who underwent diverting stoma before neoadjuvant chemoradiation
- temporary end -ostomy (+)
- uncontrolled metabolic or systemic disease
- patients who do not understand the purpose of this study because of dementia or pshycologic problem
- MRSA or Clostridium difficille (+)
- Pregnant or during breast feeding
- serious complication after sphincter saving surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Biofeedback
Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy)
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Kegel
Patients will be trained to take excersise for their anal sphincter by Kegel.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of anterior resection syndrome after stoma closure
Time Frame: 1 year after stoma closure
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1 year after stoma closure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cho HM, Kim H, Yoo R, Kim G, Kye BH. Effect of Biofeedback Therapy during Temporary Stoma Period in Rectal Cancer Patients: A Prospective Randomized Trial. J Clin Med. 2021 Nov 4;10(21):5172. doi: 10.3390/jcm10215172.
- Kye BH, Kim HJ, Kim G, Yoo RN, Cho HM. The Effect of Biofeedback Therapy on Anorectal Function After the Reversal of Temporary Stoma When Administered During the Temporary Stoma Period in Rectal Cancer Patients With Sphincter-Saving Surgery: The Interim Report of a Prospective Randomized Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3611. doi: 10.1097/MD.0000000000003611.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
August 5, 2012
First Submitted That Met QC Criteria
August 7, 2012
First Posted (Estimate)
August 10, 2012
Study Record Updates
Last Update Posted (Estimate)
February 4, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSVHCRC trial-01
- Colorectal disease (Other Identifier: Catholic University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.