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The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B).
The secondary aims are the evaluation of the following parameters:
The study is a prospective randomized clinical trial that compares two treatments in patients with LARS:
Arm A: PTNS + conservative treatment (based on predominant symptom) Arm B: only conservative treatment
The study is divided into two phases:
PRETREATMENT PHASE
The patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer, will be submitted during the first visit of the study to :
PHASE OF TREATMENT During the treatment phase, data related to the treatment and any treatment related-complications will be recorded on a special form Bowel function and quality of life will be assessed using the same questionnaires at the end of treatment. Even anorectal manometry will be repeated at the end of treatment.
It is expected to enroll approximately 12 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTNS + conservative treatment | Experimental | PTNS consists in the insertion of a small electrode above the medial malleolus adjacent to the posterior tibial nerve. An adhesive surface electrode is placed under th arch of the foot. Both electrodes are connected to the neurostimulator that generates electricity. A neuromodulation session lasts 30 minutes. The treatment plan includes 12 weekly sessions, followed by two sessions at 2-week intervals and the last one after one month. Two additional sessions of reinforcement (top-up) are provided at intervals of 6 months or earlier in case of worsening of symptoms |
|
| conservative treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTNS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| LARS score | The primary end point is the evaluation of the results of the two interventions in functional terms, by comparing the LARS score calculated first at the end and after 12 months of treatment, according to the following classification:
| 67 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-CR38 | Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-CR38 performed before and after treatment. | 67 weeks |
| EORTC QLQ-C30 | Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-C30 performed before and after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dajana Cuicchi, MD PhD | Contact | 0516363236 | +39 | cuicchidajana@yahoo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S'Orsola Malpighi University Hospital | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000094123 | Low Anterior Resection Syndrome |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 67 weeks |
| FISI | Secondary objectives will be evaluated by the change of the questionnaires FISI examinations performed before and after treatment. | 67 weeks |
| FIQL | Secondary objectives will be evaluated by the change of the questionnaires FIQL performed before and after treatment. | 67 weeks |
| ODS SCORE | Secondary objectives will be evaluated by the change of the questionnaires ODS score performed before and after treatment. | 67 weeks |
| CRQoL | Secondary objectives will be evaluated by the change of the questionnaires CRQoL performed before and after treatment. | 67 weeks |
| functional outcome | Functional outcome will be evaluated comparing manometric examinations performed before and after treatment. | 67 weeks |
| morbidity | registration of complications after each therapy session | 67 weeks |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |