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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Incidence of anterior resection syndrome after stoma closure

Outcome Time Frame:

1 year after stoma closure

Safety Issue:

No

Authority:

Korea: Institutional Review Board

Study ID:

KSVHCRC trial-01

NCT ID:

NCT01661829

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms

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