Comparison of Method for Skin Closure in Colorectal Cancer.
- Conditions
- Surgical Site InfectionColorectal Cancer
- Interventions
- Device: skin staplerDevice: skin bond
- Registration Number
- NCT06549803
- Lead Sponsor
- Yoon Suk Lee
- Brief Summary
Compared to tissue adhesives and skin stapling devices, tissue adhesives are reported to have advantages in terms of wound infection and cost competitiveness. However, there have been no prospective randomized studies focusing on wound infection rates and cost competitiveness between skin stapling devices and tissue adhesives in colorectal cancer surgery.
In colon cancer surgery, it is still unclear which skin suturing method has advantages such as lower postoperative wound infection rate and price competitiveness. The purpose of this study is to compare clinical outcomes, including wound infection rates and cost-effectiveness, between two different wound closure methods for colorectal cancer.
- Detailed Description
The primary purpose of the study is to compare and analyze the incidence of surgical site infection within 30 days after surgery in each group when tissue adhesive was applied and when skin stapling device was applied.
The purpose of the secondary study is to compare the clinical results after surgery by analyzing cost-effectiveness, pain level, and satisfaction after surgery between existing skin stapling and tissue adhesive for colon cancer patients.
Post-operative wound infection rate, cost (material costs of staplers, adhesives, material costs and service fees for disinfecting wounds occurring in the week after surgery), sex, age, BMI (body mass index), ASA (Anesthesiologists category), past history (diabetes, smoking history) , past abdominal surgery history), cancer stage, pre- and post-operative blood test results (WBC, CRP), biopsy results (cancer type), surgery time, pain on the 1st and 3rd days after surgery (VAS), length of stay, postoperative complications , compare the postoperative results of satisfaction.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 304
- underwent elective colorectal surgery
- aged 19 to 80 years
- ASA (American Society of Anesthesiologists) score: 1, 2
- surgical approach such as laparoscopic or Robotic Xi platform
- ASA score above 3
- Aged over 80 years
- underwent combined surgery for other organ resection
- uncontrolled DM
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description skin stapler skin stapler a group which skin closure was performed using skin stapler Skin adhesive bond skin bond a group which skin closure was performed using Leukosan Adhesive skin bond
- Primary Outcome Measures
Name Time Method incidence of surgical site infection within 30 days after surgery through study completion, an average of 1 year Comparative analysis of the frequency of surgical site infection up to 1 month after surgery in each group when tissue adhesive was applied and when skin stapling device was applied.
- Secondary Outcome Measures
Name Time Method Postoperative wound dressing cost through study completion, an average of 1 year Postoperative wound dressing cost between existing skin stapling and tissue adhesive for colon cancer patients.
Postoperative pain score through study completion, an average of 1 year Post-operative pain score by VAS score were measured and compared with each other by understanding various factors through cost-effectiveness analysis, pain level, satisfaction, etc. after surgery between existing skin stapling and tissue adhesive for colon cancer patients.
Trial Locations
- Locations (1)
Seoul St.Mary's hospital, the Catholic university of Korea
🇰🇷Seoul, Seocho, Korea, Republic of