Colorectal Cancer, Surgical Site Infection
Conditions
Keywords
colorectal cancer, skin adhesive bond, skin stapling
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.
Interventions
DEVICEskin bond
In the skin bond group, fascia closure is performed for incision sites of 10 mm or more, and skin bond is sufficiently applied after subcuticular suture. For incision sites less than 10 mm, subcuticular closure is performed without closing the fascia, and then skin bond is applied.
DEVICEskin stapler
In the skin stapler group, fascia closure is performed on incision sites larger than 10 mm, and the skin is closed at 2-3 mm intervals using a stapler. For incision sites less than 10 mm, skin closure is performed using a skin stapler without closing the fascia.
Sponsors
Yoon Suk Lee
Dalim BioTech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* ASA score above 3 * Aged over 80 years * underwent combined surgery for other organ resection * uncontrolled DM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
South Korea
Contacts
STUDY_CHAIRYoon Suk Lee, M.D.,Ph.D
Department of Surgery, Seoul St.Mary's hospital
Outcome results
None listed