Status:
RECRUITING
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Lead Sponsor:
University of Aarhus
Conditions:
Low Anterior Resection Syndrome
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resect...
Detailed Description
Transanal irrigation (TAI) is used as a second-line treatment following unsuccessful personalised conservative treatment (PCT) of LARS. However, it is unknown if scheduled, initiated defecation with t...
Eligibility Criteria
Inclusion
- Patients electively treated for rectal cancer with a low anterior resection.
- Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score \>29 at evaluation).
- At least 3 months after surgery (including reversal of a temporary loop-ileostomy).
- Age \>= 18 years
- Ability to understand written and spoken language actual for the including site (due to questionnaire validity).
Exclusion
- Former use of TAI
- Prior systematic use of rectal emptying aids
- Anastomotic stenosis
- History of anastomotic leakage
- Current metastatic disease or local recurrence
- Ongoing oncological treatment
- Postoperative radiotherapy for rectal cancer
- Previous or current cancer in other pelvic organs than the rectum
- Underlying diarrhoeal disease
- Inflammatory bowel disease
- Dementia
- Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms.
- Inability of patient to use TAI
- Inability and unwillingness to give informed consent
- Pregnancy or intention to become pregnant during the trial period
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04087421
Start Date
September 17 2019
End Date
December 1 2026
Last Update
May 3 2023
Active Locations (1)
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1
Aarhus University Hospital, Department of Surgery
Aarhus, Denmark, 8200