Treatment of Low Anterior Resection Syndrome by Percutaneous Nerve Evaluation and Transanal Irrigation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Low Anterior Resection Syndrome by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Percutaneous nerve evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low anterior resection for rectal cancer between May 2001 and May 2011 Exclusion Criteria: Non-radical resection metastatic disease Chemotherapy Radiotherapy Previously treated for another cancer Dementia or other mental retardation/severe mental disease Inability to read and understand the Danish language Recurrent disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PNE first<br>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 | Procedure: Percutaneous nerve evaluation<br>* Implantation of a nerve stimulator to stimulate the sacral nerve plexus<br>* Other names: Medtronic nerve stimulators;|
| Active Comparator: TAI first<br>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 | Procedure: Percutaneous nerve evaluation<br>* Implantation of a nerve stimulator to stimulate the sacral nerve plexus<br>* Other names: Medtronic nerve stimulators;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous nerve evaluation, Transanal irrigation, Low anterior resection syndrome