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New treatment option for Low Anterior Resection Syndrome
Official title Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
ClinicalTrials.gov ID: NCT04087421
What this study is testing
What is Glycerol "OBA"?
Glycerol "OBA" is an investigational medicine, being studied as a potential treatment for low anterior resection syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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).
You likely can't join if
- 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
See the full eligibility criteria
- 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).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.