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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Kye Bong-Hyeon

Assistant Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea

Suwon, , South Korea

Site Status

Countries

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South Korea

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.

Reference Type DERIVED
PMID: 34768692 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27149496 (View on PubMed)

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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