Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Hepatic Resection and Pancreatoduodenectomy

Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Hepatic Resection and Pancreatoduodenectomy - RCT about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001545

Enrollment

610

Registered

2009-01-01

Start date

2009-01-01

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

Liver disease, Pancreas disease

Interventions

Use of silk sutures in peritoneal cavity Use of absorbable sutures in peritoneal cavity

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Group 1: Hepatic resection Group 2: Pancreastoduodenectomy 2) Age ranged from 20 to 80 years old 3) Child-Pugh A or B in cirrhotic patients 4) Performance status 0-1 5) Preserved general condition; 1. WBC:3,000<=WBC<10,000 /microlitre 2. Neu:Neu>=1,500 /microlitre 3. Hb:Hb>=9.0 g/dL 4. Plt:Plt>=70,000 /microlitre 5. TB:TB<=1.5 mg/dL 6. AST:AST<=100 IU/L 7. ALT:ALT<=100 IU/L 8. Cr:Cr<=1.2 mg/dL 9. Alb:Alb>=2.8 g/dL 6) Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1) Emergency cases 2) Group 1: Biliary reconstruction in hepatic resection Group 2: Concomitant hepatic resection in pancreatoduodenectomy 3) Active infection 4) Pregnancy 5) ASA physical status 3< 6) Preoperative chemotherapy, radiotherapy, use of antibiotics within 2 weeks, use of immunosuppressive agent 7) Uncontrolled diabetes mellitus 8) Severe organ failure 9) Present stoma 10) Not eligible judged by doctor

Design outcomes

Primary

Measure	Time frame
Rate of surgical site infection occurrence	—

Secondary

Measure	Time frame
1) Rate of surgical site infection occurrence by sites (superficial incision wound, deep incision wound, organ/cavity) 2) 1. Duration until healing of surgical site infection 2. Occurrence rate in pancreas leakage or bile leakage 3. Hospital stay after surgery	—

Countries

Japan

Contacts

Public ContactYoshihiro Kakeji

Kyushu University, Graduate School of Medical Sciences Department of Surgery and Science

kakeji@surg2.med.kyushu-u.ac.jp092-642-5466

Outcome results

None listed

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