Clinical trial NCT03876561: "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"
Official title: "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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity of Low Anterior Resection Syndrome Score (LARS score)
timeFrame: 6 months following stoma closure
Secondary outcomes:
measure: Severity of fecal incontinence symptoms evaluated by the dedicated and validated score : Jorge and Wexner score
timeFrame: 6 months following stoma closure
measure: Impact on quality of life evaluated by the dedicated and validated questionnaire
timeFrame: 6 months following stoma closure
measure: Morbidity of pelvic floor prehabilitation using biofeedback.
timeFrame: 6 months following stoma closure
measure: Medico-economic impact of pelvic floor prehabilitation including the fecal incontinence related costs
timeFrame: 6 months following stoma closure
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Clichy
country: France
facility: APHP-Hôpital Beaujon
city: Nantes
country: France
facility: Clinic Jules Verne
city: Poitiers
country: France
facility: CHU de Poitiers
city: Roche Sur Yon
country: France
facility: CHD Vendée
city: Tours
country: France
facility: CHU de Tours
Study officials:
References: