"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"
NCT ID: NCT03876561
Last Updated: 2020-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
174 participants
INTERVENTIONAL
2019-05-27
2022-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
No intervention
No pelvic floor prehabilitation will be proposed before stoma closure. The pelvic floor prehabilitation will be proposed to patients suffering from LARS
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Absence of ileostomy or colostomy
* Anastomotic leakage
* Sensorial or cognitive disorders impeding pelvic floor rehabilitation exercise
* Pregnant women
* Minors
* Adults under guardianship
18 Years
80 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU Angers
Angers, , France
APHP-Hôpital Beaujon
Clichy, , France
CHD Vendée
La Roche-sur-Yon, , France
Clinic Jules Verne
Nantes, , France
CHU de Poitiers
Poitiers, , France
CHU de Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Alexandra P, Noemie P, Solene SB, Jean-Benoit H, Riche VP, Odile C, Michel G, Guy V, Hamy A, Mehdi O, Yannick T, Jeremie H L, Amar A, Emeric A, Jean-Michel B, Bridoux V, Dumont F, June F, Alexandra J, Meurette G, Duchalais E. Evaluation of pelvic floor rehabilitation in the prevention of low anterior resection syndrome: Study protocol of the CONTICARE trial. Colorectal Dis. 2025 Mar;27(3):e70045. doi: 10.1111/codi.70045.
Other Identifiers
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RC16_0459
Identifier Type: -
Identifier Source: org_study_id
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