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Comparison of transanal irrigation and glycerol suppositories in treatment of Low Anterior Resection Syndrome

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519492-25-01
Enrollment
114
Registered
2025-01-10
Start date
2019-07-24
Completion date
Unknown
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Anterior Resection Syndrome

Brief summary

The primary endpoint will be change of the main symptom score assessed by the Measure Yourself Medical Outcome Profile (MYMOP) score comparing the TAI group to the glycerol suppository group.

Detailed description

1. Assessment of bowel function with the LARS Score (27) and the Memorial Sloan-Kettering Cancer Centre (MSKCC) Bowel Function Instrument (BFI) (28)). 2. Assessment of the faecal incontinence status with The St. Mark’s Incontinence Score (29). 3. Assessment of QOL and bowel function-related QOL with the EORTC QLQ-C30 and EORTC QLQ-CR29 (30,31). 4. Assessment of urinary function with The International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms (ICIQ-M/F-L

Interventions

DRUGGlycerol "OBA"
DRUGsuppositorier

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be change of the main symptom score assessed by the Measure Yourself Medical Outcome Profile (MYMOP) score comparing the TAI group to the glycerol suppository group.

Secondary

MeasureTime frame
1. Assessment of bowel function with the LARS Score (27) and the Memorial Sloan-Kettering Cancer Centre (MSKCC) Bowel Function Instrument (BFI) (28)). 2. Assessment of the faecal incontinence status with The St. Mark’s Incontinence Score (29). 3. Assessment of QOL and bowel function-related QOL with the EORTC QLQ-C30 and EORTC QLQ-CR29 (30,31). 4. Assessment of urinary function with The International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms (ICIQ-M/F-L

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026