NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052240039

Registered date:20/05/2024

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedrectal cancer, rectal neuroendocrine tumor
Date of first enrollment20/05/2024
Target sample size186
Countries of recruitment
Study typeInterventional
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 OutcomeIncidence of small bowel obstruction within 30 days after surgery
Secondary OutcomeIncidence 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 maximumNot applicable
GenderBoth
Include criteria1.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 criteria1.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

Contact

Public contact
Name Yuki Sekido
Address Yamadaoka 2-15, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3251
E-mail ysekido@gesurg.med.osaka-u.ac.jp
Affiliation Osaka University Hospital
Scientific contact
Name Mamoru Uemura
Address Yamadaoka 2-15, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3251
E-mail muemura@gesurg.med.osaka-u.ac.jp
Affiliation Osaka University Hospital