"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"

NCT03876561 | Terminated

• 1 other identifier: RC16_0459
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Severity of fecal incontinence symptoms evaluated by the dedicated and validated score : Jorge and Wexner score

  6 months following stoma closure

• Impact on quality of life evaluated by the dedicated and validated questionnaire

  6 months following stoma closure

• Morbidity of pelvic floor prehabilitation using biofeedback.

  6 months following stoma closure

• Medico-economic impact of pelvic floor prehabilitation including the fecal incontinence related costs

  6 months following stoma closure

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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.

Procedure: Pelvic floor prehabilitation

No intervention

NO INTERVENTION

No pelvic floor prehabilitation will be proposed before stoma closure. The pelvic floor prehabilitation will be proposed to patients suffering from LARS

Interventions

Pelvic floor prehabilitation PROCEDURE

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.

Also known as: Preoperative rehabilitation

Prehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

CHU Angers

Angers, France

Location

APHP-Hôpital Beaujon

Clichy, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

Clinic Jules Verne

Nantes, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Tours

Tours, France

Location

Related Publications (1)

• 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. Erratum In: Colorectal Dis. 2025 Jun;27(6):e70138. doi: 10.1111/codi.70138.

  PMID: 40055837 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: March 15, 2019
• Study Start: May 27, 2019
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

FR (6)