Patients with rectal cancer
Conditions
Interventions
SI-449
Sponsors
Seikagaku corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria, 1.Patients who have given their written informed consent to participation in the clinical study based on voluntary agreement after a thorough explanation of subject participation is provided to them. 2.Patients who are planned to have resectomy followed by closure of a temporary ileosotomy as a part of two-stage procedure.
Exclusion criteria
Exclusion criteria: Key exclusion criteria, 1.Patients with history of surgery in the abdominal or pelvic cavity. 2.Patients with having active infection in the abdominal or pelvic cavity. 3.Patients with having active or previous history of peritonitis. 4.Patients with history of hypersensitivity to the investigational device. 5.Patients with a serious hepatic or a serious renal disorder 6.Patients who participated in another clinical study of any drug or medical device within 16 weeks prior to the day of informed consent 7.Any circumstances or conditions, which, in the opinion of the principal investigator or sub-investigator, may affect participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, Laboratory tests and manageability | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adhesions after surgery | — |
Countries
Japan
Contacts
Public ContactClinical project team SI-449
Seikagaku corporation Clinical development dept
Outcome results
None listed