A multicenter, pivotal study to demonstrate non-inferiority of Cyt-006 compared to Seprafilm in patients with primary rectal cancer and temporal colostomy underwent laparoscopic surgery
- Conditions
- primary rectal cancerrectal cancer
- Registration Number
- JPRN-jRCT2052220073
- Lead Sponsor
- Horii Yoshihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 158
1) Patients with initial and primary rectal cancer.
2) Patients with cStage 0 to cStage III.
3) Patients who are scheduled to undergo laparoscopic rectal resection and temporal colostomy.
4) Patients who are scheduled to undergo the closure of artificial anus at 8 to 48 weeks after initial surgery.
Pre-operation:
1) Patients who are scheduled to undergo open abdominal surgery.
2) Patients who had a history of intraperitoneal surgery except for appendicitis, Caesarean section, or laparoscopic cholecystectomy.
3) Patients who are scheduled to remove specimens from the site other than the midline incision (except in the case of robotic surgery).
4) Patients whose performance Status >=3. 5) Patients with 35 or higher of BMI.
During Operation:
1) Patients who need to undergo open abdominal surgery during laparoscopic procedure.
2) Patients who did not have a temporary colostomy.
3) Patients whose specimen was removed from a site other than the midline wound (except in the case of robotic surgery).
4) Patients who underwent colostomy at the umbilical site
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method presence/absence of adhesion
- Secondary Outcome Measures
Name Time Method Efficacy:<br>Severity score of adhesion<br>Range score of adhesion<br>Presence/absence of ileus<br>Success rate of pasting<br>Safety:<br>Adverse event, device failure or malfunction<br>hematologic tests, blood biochemical tests<br>vital signs