A confirmatory study of TRM-270 in comparison with Seprafilm in patients with rectal cancer receiving surgery

JRCT ID: jRCT2032220451

Registered date:21/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 21/11/2022
• Target sample size: 260
• Study type: Interventional

Intervention(s)

When performing primary tumor resection and temporary loop ileostomy, subjects will have 4 sheets of TRM-270 (quarter size) or Seprafilm (quarter size), which are anti-adhesion absorption barriers, applied to small incisions.
If investigators deem it necessary, they can be applied to sites other than under small incisions.
The maximum number of sheets to be applied is 8, including under small incision.

Outcome(s)

• Primary Outcome: Occurrence rate of adhesion in small incisions

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

- Patients aged between 18 and 80 at the time of informed consent
- Patients with initial and primary rectal cancer
- Patients with cStage 0 to cStage III
- Patients scheduled to undergo laparoscopic or robot-assisted primary tumor resection and temporary loop ileostomy
- Patients scheduled for stoma site marking
- Patients scheduled to undergo the closure of ileostomy 8 to 52 weeks after initial surgery.
- Patients with an ECOG Performance Status of 0 to 1

Exclude criteria

- Patients considered less than one year of life expectancy based on the course of their disease
- Patients with a BMI of 30 or higher
- Patients with any of the following complications:
a. Peritonitis
b. Abscess in the abdominal or pelvic cavity
c. Obstructive enteritis or intestinal obstruction
d. Infection requiring systemic treatment
e. Active double cancer
f. Disease requiring laparotomy during the study period
g. Severe diabetes or impaired glucose metabolism
h. Hypersensitivity to components of TRM-270 including metabolites such as polyethylene glycol or to Seprafilm
- Patients with any of the following history:
a. Intra-abdominal or pelvic surgery except appendicitis surgery
b. Intra-abdominal or pelvic radiotherapy performed at least 1 year before informed consent
c. Anti-VEGF antibody or anti-EGFR antibody treatment
d. Peritonitis
- Patients receiving any of the following treatments:
a. Continuous systemic administration of steroids
b. Treatment targeting cytokines
- Female patients who are pregnant, breastfeeding, have a positive pregnancy test before enrollment, or wish to become pregnant during the study period

Related Information

• Primary Sponsor: Tomita Shinpei