Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Digestive Surgery
Phase 2
Recruiting
- Conditions
- Gastric cancer, Colorectal cancer
- Registration Number
- JPRN-UMIN000001544
- Lead Sponsor
- Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 540
Inclusion Criteria
Not provided
Exclusion Criteria
1) Emergency cases 2) Group 1: Laparoscopic surgery, partial resection, combined resection of other organ for gastric cancer Group 2: Laparoscopic surgery, partial resection, resection with D0,1 lymph nodes dissection, Miles operation, Pelvic exenteration, Hartmann operation for colorectal cancer 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of surgical site infection occurrence
- Secondary Outcome Measures
Name Time Method 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. Hospital stay after surgery