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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661829
• Other study ID #: KSVHCRC trial-01
• Secondary ID: Colorectal disea
• Status: Completed
• Phase: N/A
• First received: August 5, 2012
• Last updated: February 2, 2015
• Start date: March 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of anterior resection syndrome after stoma closure		1 year after stoma closure	No