Rectal cancer
Conditions
Interventions
investigational material(s)
Generic name etc : SI-449
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : A sufficient amount of S
Sponsors
SEIKAGAKU CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Rectal cancer patients who plan to undergo laparotomy rectal resection with temporary ileostomy and second-stage ileostomy closure.
Exclusion criteria
Exclusion criteria: Patients with history of surgery in the abdominal or pelvic cavity. Patients with having active infection in the abdominal or pelvic cavity. Patients with having active or previous history of peritonitis. Patients with history of hypersensitivity to the investigational device. Patients with a serious hepatic or a serious renal disorder Patients who participated in another clinical study of any drug or medical device within 16 weeks prior to the day of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Adhesions forming under midline incision | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy other efficacy safety operability Adhesion severity Extent of adhesions The incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactKumi Ando
SEIKAGAKU CORPORATION
Outcome results
None listed