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A confirmatory study to investigate efficacy, safety and handling of TRM-270 in comparison with Seprafilm in patients with rectal cancer receiving laparoscopic or robotic-assisted surgery

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

Tomita Shinpei

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

aska-clinical@aska-pharma.co.jp

Tomita Shinpei

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

+81-80-6645-9201

aska-clinical@aska-pharma.co.jp

Complete

Nov. 21, 2022

Interventional

randomized controlled trial

single blind

active control

parallel assignment

prevention purpose

- 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

- 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

Both

Rectal cancer

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.

Occurrence rate of adhesion in small incisions

+81-463-93-1121

Oct. 26, 2022

No

none