An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients

The Catholic University of Korea

Status: Completed

Conditions: Rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01661829

Colorectal disease (Other Identifier)

KSVHCRC trial-01

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

56 participants in 2 patient groups

Biofeedback

Description:

Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy)

Kegel

Description:

Patients will be trained to take excersise for their anal sphincter by Kegel.