"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"
Reason given: lack of inclusion
Key facts
- Where
- Angers, Clichy, La Roche-sur-Yon, Nantes, Poitiers, and Tours, FranceSee the 6 sites
Where in France
- CHU AngersAngers, FranceNo longer taking part
- APHP - Hôpital BeaujonClichy, FranceNo longer taking part
- CHD VendéeLa Roche-sur-Yon, FranceNo longer taking part
- Clinic Jules VerneNantes, FranceNo longer taking part
- CHU de PoitiersPoitiers, FranceNo longer taking part
- CHU de ToursTours, FranceNo longer taking part
Trial details
- Who runs it
- Nantes University Hospital
- Trial code
- NCT03876561
- Record updated
- 20 April 2026
- Original description
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.Read full original descriptionShow less
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.
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; Sensorial or cognitive disorders impeding pelvic floor rehabilitation exercise; Absence of ileostomy or colostomy; Anastomotic leakage; Pregnant women; Minors; Adults under guardianship.