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Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome

NCT04087421 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-05-03

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

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.

DRUG

Glycerol "OBA"

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Peter Christensen · Research Unit, Dept. of Surgery, Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04087421 on ClinicalTrials.gov