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

A multicenter randomized controlled trial of the efficacy of anti-adhesion barrier for pelvic peritoneal defects in laparoscopic rectal amputation - ASPIRE study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052240039
Enrollment
186
Registered
2024-05-20
Start date
2024-05-20
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, rectal neuroendocrine tumor rectal cancer, rectal neuroendocrine tumor, surgery, anti-adhesion barrier

Interventions

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
surgery, anti-adhesion barrier

Sponsors

Uemura Mamoru
Lead Sponsor
Eguchi Hidetoshi
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Incidence of small bowel obstruction within 30 days after surgery

Secondary

MeasureTime frame
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

Contacts

Public ContactYuki Sekido

Osaka University Hospital

ysekido@gesurg.med.osaka-u.ac.jp+81-6-6879-3251

Outcome results

None listed

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