5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS) (RaLARS)

Seoul National University

Status: Enrolling

Conditions: LARS - Low Anterior Resection Syndrome

Treatments: Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT05577845

2208-086-1351

Details and patient eligibility

About

Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Enrollment: 212 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

212 participants in 2 patient groups

Ramosetron

Experimental group

Treatment:

Drug: Ramosetron

Loperamide

Active Comparator group

Treatment:

Drug: Ramosetron