NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001545

Registered date:01/01/2009

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedLiver disease, Pancreas disease
Date of first enrollment2009/01/01
Target sample size610
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Use of silk sutures in peritoneal cavity Use of absorbable sutures in peritoneal cavity

Outcome(s)

Primary OutcomeRate of surgical site infection occurrence
Secondary Outcome1) 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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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

Related Information

Contact

public contact
Name Yoshihiro Kakeji
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582 Japan
Telephone 092-642-5466
E-mail kakeji@surg2.med.kyushu-u.ac.jp
Affiliation Kyushu University, Graduate School of Medical Sciences Department of Surgery and Science
scientific contact
Name Yoshihiko Maehara
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582 Japan
Telephone 092-642-5466
E-mail
Affiliation Kyushu University, Graduate School of Medical Sciences Department of Surgery and Science