An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients
NCT ID: NCT01661829
Last Updated: 2015-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
56 participants
OBSERVATIONAL
2012-03-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Biofeedback
Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy)
No interventions assigned to this group
Kegel
Patients will be trained to take excersise for their anal sphincter by Kegel.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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The Catholic University of Korea
OTHER
Responsible Party
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Kye Bong-Hyeon
Assistant Clinical Professor
Locations
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Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea
Suwon, , South Korea
Countries
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References
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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.
Other Identifiers
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Colorectal disease
Identifier Type: OTHER
Identifier Source: secondary_id
KSVHCRC trial-01
Identifier Type: -
Identifier Source: org_study_id
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