RecruitingPhase 3NCT04087421

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


Sponsor

University of Aarhus

Enrollment

114 participants

Start Date

Sep 17, 2019

Study Type

INTERVENTIONAL

Conditions

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 Resection Syndrome (LARS).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for people who develop bowel problems after surgery for rectal cancer — a condition called Low Anterior Resection Syndrome (LARS). Symptoms can include unpredictable bowel movements, urgency, and incontinence. The two treatments being compared are transanal irrigation (flushing out the bowel with water) and glycerol suppositories. **You may be eligible if...** - You had surgery for rectal cancer (low anterior resection) at least 3 months ago - You have significant bowel problems (LARS score above 29) that have not improved with initial treatment - You are 18 or older **You may NOT be eligible if...** - You have used transanal irrigation before - You have a narrowing at the surgical join (anastomotic stenosis) or a history of leakage at the join - Your cancer has returned or spread - You have another bowel condition like inflammatory bowel disease - You are currently receiving cancer treatment - You have had radiation to your pelvis after surgery - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEQufora 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.

DRUGGlycerol "OBA"

Rectal suppository. Stimulates the rectum and softens and loosens stool.


Locations(1)

Aarhus University Hospital, Department of Surgery

Aarhus, Denmark

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NCT04087421


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