Rectal Cancer
Conditions
Brief summary
The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy repair operation in patient with rectal cancer improve a bowel function.
Interventions
DIETARY_SUPPLEMENTCJLP243
Perioperative administration till postoperative weeks 3
DIETARY_SUPPLEMENTPlacebo
Perioperative administration till postoperative weeks 3
Sponsors
HK inno.N Corporation
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
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 20-75 * with rectal cancer * s/p low anterior resection (double stapled anastomosis)
Exclusion criteria
* Metastatic cancer * Pregnancy * Valvular heart disease * s/p intersphincteric resection (index surgery) * h/o anastomotic leakage (index surgery) * medically unfit (cardiopulmonary dysfunction, sepsis etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Anterior Resection Syndrome score | Postoperative weeks 3 | — |
| Memorial Sloan Kettering Cancer Center bowel function index | Postoperative weeks 3 | Subscale: frequency score |
Secondary
| Measure | Time frame |
|---|---|
| Low Anterior Resection Syndrome score | Postoperative week 1 |
| Change of bowel functions index | Between postoperative week 1 to 3 |
| EORTC CR (Colorectal) 29 | Postoperative week 1 and 3 |
| Postoperative complication | till Postoperative weeks 3 |
| EORTC C30 | Postoperative week 1 and 3 |
| Memorial Sloan Kettering Cancer Center bowel function index | Postoperative week 1 |
Outcome results
None listed