An interventional study of Percutaneous nerve evaluation in Rectal Cancer, sponsored by University of Aarhus. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-07.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
85 studies on the registry are indexed under Low Anterior Resection Syndrome; 36 are open to participants now.
This study's enrollment of 14 is below the median of 67 across 57 interventional studies indexed under Low Anterior Resection Syndrome.
Browse Low Anterior Resection Syndrome studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Implantation of a nerve stimulator to stimulate the sacral nerve plexus
Also known as: The Peristeen Anal Irrigation System, Medtronic nerve stimulators
changes in LARS score
A symptom score ranging from 0 to 42 points calculated on the basis of bowel function
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
Sexual function
self-reported sexual function measured by validated questionnaires
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
Bladder function
self-reported bladder function by validated questionnaires
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
Incontinence
faecal incontinence measured by wexner score and St. Marks incontinence score
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
Patient Satisfaction
patient satisfaction measured on a VAS
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Low Anterior Resection Syndrome→
University of Aarhus