"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"

Rectal Cancer Clinical Trial

— CONTICARE  

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03876561
• Other study ID #: RC16_0459
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: May 2022

Study information

• Verified date: April 2020
• Source: Nantes University Hospital
• Contact: Guillaume MEURETTE
• Phone: 0240083027
• Email: guillaume.meurette[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: May 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Pelvic floor prehabilitation
The systematic pelvic floor prehabilitation will start 4 weeks before stoma closure and will include 1 session per week before stoma closure and 1 session per week during 6 weeks following stoma closure. The prehabilitation will be performed according to a predefined protocol based on a biofeedback strategy.

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	APHP-Hôpital Beaujon	Clichy
France	Clinic Jules Verne	Nantes
France	CHU de Poitiers	Poitiers
France	CHD Vendée	Roche Sur Yon
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Low Anterior Resection Syndrome Score (LARS score)	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)	6 months following stoma closure
Secondary	Severity of fecal incontinence symptoms evaluated by the dedicated and validated score : Jorge and Wexner score	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)	6 months following stoma closure
Secondary	Impact on quality of life evaluated by the dedicated and validated questionnaire	questionnaire quality of life to assess the global quality of life in patients suffering from colorectal cancer Total score is reported	6 months following stoma closure
Secondary	Morbidity of pelvic floor prehabilitation using biofeedback.	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.	6 months following stoma closure
Secondary	Medico-economic impact of pelvic floor prehabilitation including the fecal incontinence related costs	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.	6 months following stoma closure