A multicenter randomized controlled trial of the efficacy of anti-adhesion barrier in laparoscopic rectal amputation

JRCT ID: jRCTs052240039

Registered date:20/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: rectal cancer, rectal neuroendocrine tumor
• Date of first enrollment: 20/05/2024
• Target sample size: 186
• Study type: Interventional

Intervention(s)

1) With anti-adhesion barrier group
Patients undergo laparoscopic rectal amputation within 28 days of enrollment. Anti-adhesive barrier (Adspray) will be sprayed on the peritoneal defect in the pelvic cavity before wound closure. No other anti-adhesive barrier should be used. Spraying of anti-adhesive barrier outside the pelvic cavity (e.g., just below the midline wound) is acceptable.

2) Without anti-adhesion barrier group
Patients undergo laparoscopic rectal amputation within 28 days of enrollment. No anti-adhesive barrier should be used. Spraying of anti-adhesive barrier outside the pelvic cavity (e.g., just below the midline wound) is not acceptable.

Outcome(s)

• Primary Outcome: Incidence of small bowel obstruction within 30 days after surgery

Secondary Outcome

Incidence of small bowel obstruction (Clavien-Dindo classification Grade III or higher) within 30 days after surgery
Incidence of surgery site infection within 30 days after surgery
Drain culture results on postoperative day 1, day 3, and before evacuation
Postoperative days until resumption of oral intake
Postoperative hospital stay
Incidence of small bowel obstruction within 5 years after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.The patient must be at least 18 years of age at the time of enrollment.
2.The patient diagnosed with rectal cancer (including NET).
3.Patients scheduled for laparoscopic perineal rectal resection (including robot-assisted surgery).
4.The patient fully understand the study.
5.The patient has been fully informed of the contents of the study and has given written consent.

Exclude criteria

1.The Patient with a history of transperitoneal surgery for pelvic organs.
2.The patient who are scheduled to undergo a combined resection of other organs.
3.The patient with pelvic infection.
4.The patient with a history of hypersensitivity to substances derived from corn starch.
5.The patient with glycogen storage disease.
6.The patient who is pregnant, may become pregnant, or wishes to become pregnant during the treatment period.
7.Any other patient who is judged by the physician to be inappropriate as a subject of the study.

Related Information

• Primary Sponsor: Uemura Mamoru
• Secondary Sponsor: Eguchi Hidetoshi
• Source(s) of Monetary Support: TERUMO