TerminatedNot Applicable

"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"

Stopped: lack of inclusion

France120 participantsStarted 2019-05-27

Plain-language 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 designed to assess pelvic floor prehabilitation using biofeedback in the prevention of LARS following total mesorectal excision for cancer. The pelvic floor rehabilitation with biofeedback has already been tested postoperatively in patients suffering from LARS with heterogeneous results. However, this rehabilitation has never been evaluated in the prevention of LARS. The prehabilitation is an innovative concept currently evaluated in the prevention of functional complications following orthopedic surgery and also prostate surgery. In high-risk abdominal surgery, cardiopulmonary prehabilitation offers satisfying results in terms of morbidity and mortality rates. This study will be the first to assess pelvic floor prehabilitation in the prevention of LARS.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Severity of Low Anterior Resection Syndrome Score (LARS score)

Timeframe: 6 months following stoma closure

Trial details

NCT IDNCT03876561

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-17