"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"

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: Pelvic floor prehabilitation

• Registration Number: NCT03876561
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Study Start: 2019-05-27
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03
• Primary Completion: 2021-10
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Pelvic floor prehabilitation	The systematic pelvic floor prehabilitation will start 4 weeks before stoma closure and will include 1 sessions per week before stoma closure and 1 sessions per week during 6 weeks following stoma closure. Complementary sessions are allowed if necessary.

Primary Outcome Measures

Name	Time	Method
Severity of Low Anterior Resection Syndrome Score (LARS score)	6 months following stoma closure	questionnaire assessing the five symptoms of the Low Anterior Resection Syndrome : fecal incontinence, gas incontinence, stool frequency, stool clustering and urgency.Total score is reported (minimum score :0 / maximal score : 42)

Secondary Outcome Measures

Name	Time	Method
Severity of fecal incontinence symptoms evaluated by the dedicated and validated score : Jorge and Wexner score	6 months following stoma closure	questionnaire to assess the severity of fecal incontinence symptoms, including stool frequency, stool and gas leakage, social impact and the frequency of pads.a total score is reported (minimum score :0 / maximal score : 20)
Impact on quality of life evaluated by the dedicated and validated questionnaire	6 months following stoma closure	questionnaire quality of life to assess the global quality of life in patients suffering from colorectal cancer Total score is reported
Morbidity of pelvic floor prehabilitation using biofeedback.	6 months following stoma closure	Biofeedback prehabilitation requires a small rectal manometry probe. This outcome will evaluate the morbidity of the rectal introduction of the probe following a colorectal anastomosis.
Medico-economic impact of pelvic floor prehabilitation including the fecal incontinence related costs	6 months following stoma closure	The fecal incontinence related costs will be quantified by the data obtained from the social security insurance and the patients' estimation. The differential benefit of the pelvic floor prehabilitation will be correlated to the quality of life estimated by the QALYS using the EQ-5D questionnaire.

Trial Locations

Locations (6)

CHU Angers; 🇫🇷 Angers, France

APHP-Hôpital Beaujon; 🇫🇷 Clichy, France

CHU de Poitiers; 🇫🇷 Poitiers, France

CHD Vendée; 🇫🇷 Roche Sur Yon, France

Clinic Jules Verne; 🇫🇷 Nantes, France

CHU de Tours; 🇫🇷 Tours, France