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A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)

A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED) - Balsam CEED study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040969
Enrollment
400
Registered
2020-09-01
Start date
2020-09-01
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

postoperative bowel obstruction

Interventions

None listed

Sponsors

Nippon medical school
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Cases histologically proven as colorectal cancer 2) Cases without metastatic lesions and/or invasion to the adjacent organs 3) Cases performed laparoscopic surgery 4) Cases performed curative surgery 5) Cases using INTERCEED as an adhesion barrier material 6) Patients between the ages of 20 and 80 7) Patients with ECOG Performance states 0-1 8) Cases enrolled within 3 days of surgery 9) Patients with all of the following on examination within 1 month prior to enrollment, with preserved major organ function and no suspected active infection -White blood cell count: 3,000/mm3 or higher -Platelet count: 75,000/mm3 or higher -Hemoglobin: 8.0 g/dl or higher -Serum AST and ALT: 2.5 times or less than the upper limit of the institutional reference value -Serum total bilirubin: less than 1.5 mg/dl -Serum creatinine: 1.5 mg/dl or less

Exclusion criteria

Exclusion criteria: 1) Patients for whom Interseed is contraindicated 2) Patients who received previous abdominal surgery (except for appendectomy performed more than 5 years ago). Anterior approach to inguinal hernia surgery is acceptable. 3) Patients deemed ineligible to participate in this study bytheir physicians 4) Patients with cancer recurrence within 2 years will be excluded at the time of statistical analysis. 5) Cases cannot followed for 2 years will be excluded a the time of statistical analysis.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)

Countries

Japan

Contacts

Public ContactHiromichi Sonoda

Nippon medical school Department of Gastrointestinal and Hepatp-Biliary-Pancreatic Surgery

hiromichi-sonoda@nms.ac.jp0338222131

Outcome results

None listed

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