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

JRCT ID: jRCT2052220073

Registered date:10/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: primary rectal cancer
• Date of first enrollment: 10/08/2022
• Target sample size: 158
• Study type: Interventional
• Intervention(s): Application of the anti-adhesion barrier

Outcome(s)

• Primary Outcome: presence/absence of adhesion

Secondary Outcome

Efficacy:
Severity score of adhesion
Range score of adhesion
Presence/absence of ileus
Success rate of pasting
Safety:
Adverse event, device failure or malfunction
hematologic tests, blood biochemical tests
vital signs

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Horii Yoshihiro