Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.

Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose. - Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018727

Enrollment

200

Registered

2015-08-23

Start date

2015-09-02

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

Abdominal laparoscopic surgery for colon and rectum

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects who are 20 years or older 2. Subjects undergoing abdominal laparoscopic surgery 3. Subjects with the will of participating in the study, and provided written informed consent 4. Subjects in whom the use of INTERCEED may be considered during the planned surgery.

Exclusion criteria

Exclusion criteria: 1. Subjects in whom the laparoscopic procedure needs to be converted to open surgery. 2. Patients in whom significant adhesive disease is already present at the inception of the procedure requiring adhesiolysis that impacts surgical time. 3. Subjects in whom a complete excision of the tumor could not be achieved. 4. Subjects with intraoperative intraperitoneal administration of chemotherapy. 5. Subjects with severe hepatic dysfunction, renal failure, heart disease and infectious disease. 6. Subjects in whom alternate adhesive prevention methods are used 7. Subjects in whom complete hemostasis could not be achieved at the location where INTERCEED was going to be used 8. Subjects in whom the location where INTERCEED was going to be used is considered infected 9. Subjects with history of severe drug allergy. 10. Subjects with allergy of oxidized regenerated cellulose. 11. Subjects in whom the treating physician does not feel that the application of INTERCEED is appropriate

Design outcomes

Primary

Measure	Time frame
Adhesive Intestinal Obstruction	—

Secondary

Measure	Time frame
- Revision surgery -- Revision surgery related to postoperative bleeding -- Revision surgery related to anastomotic leak/ drainage - Surgical Site Infection (SSI) -- Superficial incisional surgical site infection -- Deep incisional surgical site infection -- Organ surgical site infection - Anastomotic leak - Other adverse events that lead to therapeutic interventions (surgery and/ or medication that differ from the standard pathway of care) - Death	—

Measure

Time frame

- Revision surgery -- Revision surgery related to postoperative bleeding -- Revision surgery related to anastomotic leak/ drainage - Surgical Site Infection (SSI) -- Superficial incisional surgical site infection -- Deep incisional surgical site infection -- Organ surgical site infection - Anastomotic leak - Other adverse events that lead to therapeutic interventions (surgery and/ or medication that differ from the standard pathway of care) - Death

—

Countries

Japan

Contacts

Public ContactMasanori Naito

Kitasato University School of Medicine Department of Surgery

mnaito@kitasato-u.ac.jp042-778-8111

Outcome results