Anterior Resection Syndrome
Conditions
Brief summary
Poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But, currently there has been no specific treatment for ARS and symptom based empirical management is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has been revealed to be slowing the bowel movement and improving stool consistency and urgency. We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS
Interventions
DRUGRamosetron
Sponsors
Dong-A ST
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patients who undergo sphincter saving surgery for rectal cancer
Exclusion criteria
* recurred rectal cancer * rectal cancer with distant metastasis * permanent stoma formation * postoperative concurrent chemoradiotherapy * uncontrolled medical disease * inflammatory bowel disease * uncontrolled constipation * preoperative incontinence (LARS score, more than 20) * allergic to intervention drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| low anterior resection syndrome score | 4 weeks | questionnaire with comparison of frequency or urgency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life score | 4 weeks | EORTC QLQ C30 (Korean version, validated) |
Contacts
Primary ContactKyu Joo Park, MD, PhD
Backup ContactSeung-Bum Ryoo, MD
Outcome results
None listed