Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Digestive System Diseases+8

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2012
See protocol details

Summary

Principal SponsorThe Catholic University of Korea
Last updated: February 4, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01661829
Principal SponsorThe Catholic University of Korea
Last updated: February 4, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal NeoplasmsRectal Neoplasms

Criteria

7 inclusion criteria required to participate
adult who is 17 years or older
if woman is childbearing age, her pregnancy test shoud be indentified 'negative'
neoadjuvant chemoradiation therapy (+)
patinet who aggree with our study
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8 exclusion criteria prevent from participating
MRSA or Clostridium difficille (+)
Pregnant or during breast feeding
patients who do not understand the purpose of this study because of dementia or pshycologic problem
patients who have been enrolled to other clinical studies related to this study
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Suwon, South KoreaOpen Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea in Google Maps
CompletedOne Study Center