Rectal CancerCONTICARENCT03876561
"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"
A study testing Pelvic floor prehabilitation in people with Rectal Cancer, run by Nantes University Hospital at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Pelvic floor prehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesFrance
- Study dates
- 27 May 2019to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Angers
Angers
APHP-Hôpital Beaujon
Clichy
CHD Vendée
La Roche-sur-Yon
Clinic Jules Verne
Nantes
CHU de Poitiers
Poitiers
CHU de Tours
Tours
About this study
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
- Being tested
- Pelvic floor prehabilitation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor prehabilitationProcedure or surgery
Also called Preoperative rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months following stoma closure
Secondary outcomes (4)
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)
Measured: 6 months following stoma closure
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
Measured: 6 months following stoma closure
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.
Measured: 6 months following stoma closure
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.
Measured: 6 months following stoma closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start27 May 2019
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876561
- Sponsor's protocol ID
- RC16_0459
- Acronym
- CONTICARE
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2019
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40055837
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03876561
- Acronym / sponsor ID
- CONTICARE / RC16_0459
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Procedure: Pelvic floor prehabilitationThe 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. |
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor prehabilitationAlso: Preoperative rehabilitationThe 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. | Procedure or surgery | Prehabilitation |
Primary outcome
Severity of Low Anterior Resection Syndrome Score (LARS score)
Time frame: 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)
4 secondary outcomes
Severity of fecal incontinence symptoms evaluated by the dedicated and validated score : Jorge and Wexner score
Time frame: 6 months following stoma closure
Impact on quality of life evaluated by the dedicated and validated questionnaire
Time frame: 6 months following stoma closure
Morbidity of pelvic floor prehabilitation using biofeedback.
Time frame: 6 months following stoma closure
Medico-economic impact of pelvic floor prehabilitation including the fecal incontinence related costs
Time frame: 6 months following stoma closure
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 40055837Alexandra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor prehabilitation in people with Rectal Cancer, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Low Anterior Resection Syndrome Score (LARS score) (time frame: 6 months following stoma closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.