Status:

UNKNOWN

"Impact of Pelvic Floor Prehabilitation Using Biofeedback on the Severity of the Low Anterior Resection Syndrome in Patients Undergoing a Total Mesorectal Excision for Rectal Cancer"

Lead Sponsor:

Nantes University Hospital

Conditions:

Rectal Cancer

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

There is currently no specific treatment and only few measures to prevent the low anterior resection syndrome (LARS). The LARS often results in a severe alteration of quality of life. This study is de...

Eligibility Criteria

Inclusion

  • Age between 18 and 80 years old
  • Total mesorectal excision with colorectal or coloanal anastomosis protected by an ileostomy or a colostomy for rectal cancer
  • Absence of anastomotic leakage or stenosis
  • Informed consent to participate in the study
  • Social security insurance affiliation

Exclusion

  • History of anal incontinence and/or fecal urgency and/or chronic diarrhea requiring a specific treatment before rectal cancer management
  • Absence of ileostomy or colostomy
  • Anastomotic leakage
  • Sensorial or cognitive disorders impeding pelvic floor rehabilitation exercise
  • Pregnant women
  • Minors
  • Adults under guardianship

Key Trial Info

Start Date :

May 27 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2022

Estimated Enrollment :

174 Patients enrolled

Trial Details

Trial ID

NCT03876561

Start Date

May 27 2019

End Date

May 1 2022

Last Update

April 3 2020

Active Locations (6)

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Page 1 of 2 (6 locations)

1

CHU Angers

Angers, France

2

APHP-Hôpital Beaujon

Clichy, France

3

CHD Vendée

La Roche-sur-Yon, France

4

Clinic Jules Verne

Nantes, France