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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01661829

Enrollment

Registered

2012-08-10

Start date

2012-03-31

Completion date

2015-02-28

Last updated

2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of anterior resection syndrome after stoma closure	1 year after stoma closure

Countries

South Korea

Outcome results