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A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic rectal surgery using an adhesion barrier material (Seprafilm)

A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic rectal surgery using an adhesion barrier material (Seprafilm) - BALSAM 2 study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000046463
Enrollment
275
Registered
2022-01-01
Start date
2022-04-25
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

Interventions

None listed

Sponsors

Nippon Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A) Histologically confirmed stage I-III rectal carcinoma B) Without metastasis and/or invasion of adjacent organs C) Laparoscopic or robotic surgery performed D) Curative surgery performed E) Using anti-adhesion barriers (Seprafilm, Interceed, and Adspray) during rectal cancersurgery F) Patient with age between 20 and 80 years G) Any intervals between initial surgery (rectal cancer surgery) and ileostomy reversal H) Patient with an Eastern Cooperative Oncology GroupPerformance Status of 0 or 1 I) Exhibiting sufficient organ function within 1 month prior to enrollment in the study with the following parameters considered: -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: A) Contraindications for Seprafilm use B) History of previous abdominal surgery, except for appendectomy, laparoscopic cholecystectomy, and cesarean section performed >5 years prior C) Cases of small bowel obstruction prior to ileostomy reversal D) The treating physician did not feel that the use of Seprafilm was appropriate

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative small bowel obstruction 2 years after ileostomy reversal

Countries

Japan

Contacts

Public ContactAkihisa Matsuda

Nippon Medical School Hospital Department of Gastrointestinal Hepato-Biliary-Pancreatic Surgery

a-matsu@nms.ac.jp+81-3-3822-2131

Outcome results

None listed

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