Informations générales (source: ClinicalTrials.gov)
"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" (CONTICARE)
Interventional
N/A
Nantes University Hospital (Voir sur ClinicalTrials)
mai 2019
mai 2022
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Beaujon | Yves Panis | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Angers - Angers - France | Antoine Hamy | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - Poitiers - France | Marie-Line Barussaud | Contact (sur clinicalTrials) | |||
| CHU de Tours - Tours - France | Mehdi Ouaissi | Contact (sur clinicalTrials) | |||
| Clinic Jules Verne - Nantes - France | Jean-Michel Balon | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHD Vendée - Roche Sur Yon - France | Eric Abet | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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