Investigator initiated non-inferiority study of Cyt-004 compared to Seprafilm in patients with primary rectal cancer scheduled for defunctioning stoma after laparoscopic surgery

JRCT ID: jRCT2032200056

Registered date:22/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: rectal cancer
• Date of first enrollment: 22/06/2020
• Target sample size: 158
• Study type: Interventional
• Intervention(s): Cyt-004(absorbable barrier for preventing adhesion)

Outcome(s)

• Primary Outcome: presence/absence of adhesion

Secondary Outcome

Severity score of adhesion
Range score of adhesion
presence/absence of ileus
Success rate of pasting

Key inclusion & exclusion criteria

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

Include criteria

Subjects who meet all of the following standards are judged to be eligible.
1.Patients with initial and primary rectal cancer.
2.Patients with cStage 0 to cStage III at the point of pre-registration examination.
3.Patients who are scheduled to undergo laparoscopic rectal resection followed by defunctioning stoma.
4.Patients who are scheduled to undergo the closure of artificial anus 8 to 48 weeks after initial surgery.
5.Patients aged 20 years or older at the time of obtaining an informed consent.
6.Patients voluntarily provided written consent form for participating in this study.

Exclude criteria

Patients who do not infringe on all of the following standards are judged to be eligible.
1.Patients who are scheduled to undergo laparotomy for rectal resection.
2.Patients who had a history of intraperitoneal surgery except for appendicitis.
3.Patients who are scheduled to remove specimens from the site other than the midline incision.
4.Patients who are scheduled to defunctioning stoma at umbilical site.
5.Patients whose performance Status>=3
6.Patients suffering from peritonitis or require emergency operation.
7.Patients participating in other clinical trials or participated within 3 months.
8.Pregnant or breastfeeding females who are willing to be pregnant during the observation period of this clinical study, or males wishing to their partner's pregnancy.
9.Patients with 35 or higher of BMI
10.Any other patients judged to be disqualified by the principal investigator or sub-investigators.

Related Information

• Primary Sponsor: Sakamoto Kazuhiro
• Source(s) of Monetary Support: Cytori Therapeutics K.K.