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A randomised trial testing the effect of percutaneous nerve evaluation and transanal irrigation on bowel function in patients after low anterior resection for rectal cancer.
Patients will undergo anal physiological assessment and will then be randomized to either treatment arm. The first 12 weeks they will be optimized in the conservative treatment of their bowel function before beginning active treatment with TAI or PNE. After 8 and 4 weeks respectively, the treatment will stop and they will have a period of 4 weeks back on optimized conservative treatment before beginning active treatment in the other active arm.
Detailed records of bowel, micturition and sexual function and QoL will be obtained at regular intervals during the entire trial fase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNE first | Active Comparator | patients randomised to start with PNE stimulation over 4 weeks. Then the stimulator will be removed and after a wash out period of 4 weeks they will be trained in transanal irrigation |
|
| TAI first | Active Comparator | Patients randomised to start with transanal irrigation treatment in 8 weeks, thereafter a wash out period of 4 weeks before being implanted with a neuro stimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous nerve evaluation | Procedure | Implantation of a nerve stimulator to stimulate the sacral nerve plexus |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in LARS score | A symptom score ranging from 0 to 42 points calculated on the basis of bowel function | baseline, 12, 16, 20, 24 and 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function | self-reported sexual function measured by validated questionnaires | baseline, 12, 16, 20, 24 and 28 weeks |
| Bladder function | self-reported bladder function by validated questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrine J. Emmertsen, MD | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorectal Surgical Department P, Aarhus University Hospital | Aarhus | 8000 | Denmark |
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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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| baseline, 12, 16, 20, 24 and 28 weeks |
| Incontinence | faecal incontinence measured by wexner score and St. Marks incontinence score | baseline, 12, 16, 20, 24 and 28 weeks |
| Patient Satisfaction | patient satisfaction measured on a VAS | baseline, 12, 16, 20, 24 and 28 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 |