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lack of inclusion
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| APHP-Hôpital Beaujon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40055837 | Derived | 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. |
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| 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 |
| 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 |
| 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 |
| Clichy |
| France |
| CHD Vendée | La Roche-sur-Yon | France |
| Clinic Jules Verne | Nantes | France |
| CHU de Poitiers | Poitiers | France |
| CHU de Tours | Tours | France |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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