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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Implantation of a nerve stimulator to stimulate the sacral nerve plexus
Colorectal Surgical Department P, Aarhus University Hospital
Aarhus, Denmark
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.