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Clinical Trials/NCT01661829
NCT01661829
Completed
Not Applicable

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

The Catholic University of Korea1 site in 1 country56 target enrollmentStarted: March 2012Last updated:
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ConditionsRectal Cancer

Overview

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
1
Primary Endpoint
Incidence of anterior resection syndrome after stoma closure
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of anterior resection syndrome after stoma closure

Time Frame: 1 year after stoma closure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kye Bong-Hyeon

Assistant Clinical Professor

The Catholic University of Korea

Study Sites (1)

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