Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
NCT ID: NCT04087421
Last Updated: 2023-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
114 participants
INTERVENTIONAL
2019-09-17
2026-12-31
Brief Summary
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Detailed Description
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The study is a multi-centre, randomised, controlled, 12 weeks, parallel-group trial comparing treatment with TAI to treatment with glycerol suppositories. Patients will be randomised - stratified by centre and neoadjuvant radiotherapy - in a 1:1 ratio to receive treatment with TAI or glycerol suppositories. Primary endpoint will be assessed by the end of week twelve.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transanal irrigation
Participants receiving TAI will irrigate once/day with stepwise volumes; 1. month 150 ml, 2. month 300 ml, and 3. month 500 ml.
Qufora Irrisedo Cone System
The system works by connecting a tube from a water bag to a cone. The cone is placed into the rectum and the prescribed water volume is pumped into the rectum. When the water has been installed the valve is closed and the cone removed. Residual water and stool will then flow into the toilet.
Glycerol suppositories
Participants treated with glycerol suppositories will administer one glycerol suppository once/day.
Glycerol "OBA"
Rectal suppository. Stimulates the rectum and softens and loosens stool.
Interventions
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Qufora Irrisedo Cone System
The system works by connecting a tube from a water bag to a cone. The cone is placed into the rectum and the prescribed water volume is pumped into the rectum. When the water has been installed the valve is closed and the cone removed. Residual water and stool will then flow into the toilet.
Glycerol "OBA"
Rectal suppository. Stimulates the rectum and softens and loosens stool.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Peter Christensen
Role: PRINCIPAL_INVESTIGATOR
Research Unit, Dept. of Surgery, Aarhus University Hospital, Denmark
Locations
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Aarhus University Hospital, Department of Surgery
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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676869
Identifier Type: -
Identifier Source: org_study_id
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