LARS - Low Anterior Resection Syndrome
Conditions
Brief summary
Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
Interventions
DRUGRamosetron
Ramosetron, 4 weeks
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* mid and low rectal cancer (AV\<15cm) * stage II, III, preop long-course CCRT, then ileostomy repair * about 1\ 12 months after operation (no stomy) * about 1\ 6 months after ileostomy repair * major LARS
Exclusion criteria
* recurred rectal cancer * stage IV * IBD * uncontrolled preoperative fecal incontinence or constipation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major Low Anterior Resection Syndrome (LARS) | 0 weeks | LARS score (0-20, no, 21-29, minor, 30-42, major) |
| Difference of improvement of major Low Anterior Resection Syndrome (LARS) | 4 weeks | LARS score (0-20, no, 21-29, minor, 30-42, major) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 score | 0 weeks | Quality of life surveillance |
Countries
South Korea
Outcome results
None listed