NCT04087421RecruitingPhase 3
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 Resection Syndrome (LARS).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 26 Aug 2019
- Start date
- 17 Sept 2019
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Colorectal cancer
- NCT number
- NCT04087421
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 114
- From 17 Sept 2019 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systematic use of rectal emptying aids
- Previous or current cancer in other pelvic organs than the rectum
Other illness
- History of anastomotic leakage
- Current metastatic disease or local recurrence
- Postoperative radiotherapy for rectal cancer
- 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.
Other
- Former use of TAI
- Anastomotic stenosis
- Ongoing oncological treatment
- Inability of patient to use TAI
- Inability and unwillingness to give informed consent
- Pregnancy or intention to become pregnant during the trial period
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital, Department of Surgery Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.