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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2032200056

Enrollment

158

Registered

2020-06-22

Start date

2020-06-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

Cyt-004(absorbable barrier for preventing adhesion)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
presence/absence of adhesion	—

Secondary

Measure	Time frame
Severity score of adhesion Range score of adhesion presence/absence of ileus Success rate of pasting	—

Contacts

Public ContactMorikuni Tobita

Juntendo University Hospital

cyt-004@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026