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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Suwon, 442-723, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of anterior resection syndrome after stoma closure

Time frame: 1 year after stoma closure

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Aug 10, 2012
Registry last updated: Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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