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( Chel Hun Choi ),( Nam Kyeong Kim ),( Kidong Kim ),( Yong Jae Lee ),( Keun Ho Lee ),( Jong-min Lee ),( Kwang Beom Lee ),( Dong Hoon Suh ),( Sunghoon Kim ),( Min Kyu Kim ),( Seok Ju Seong ),( Myong Ch 대한산부인과학회 2022 대한산부인과학회 학술대회 Vol.108 No.-
Objective: To identify the effect of subcutaneous (SQ) drain on wound dehiscence and infection in patients who underwent midline laparotomy for gynecological disease. Methods: Patients planned to undergo midline laparotomy for gynecologic disease, BMI< 35, age >18 years and ECOG performance status 0-2 were 1:1 randomized to case (with SQ drain) vs. control (without SQ drain) at 9 institutes in Korea, from February 2021 to December 2021. We compared the incidence of wound dehiscence at 4 weeks post-surgery and cumulative incidence of wound dehiscence and infection up to 4 weeks post-surgery between case and control group. Results: Of the 174 randomized patients (case 84, control 90), 12 patients were dropped due to follow-up loss (case 5, control 7) and 162 patients (intention-to-treat [ITT] cohort: case 79, control 83) were included. Fourteen patients (case 10, control 4) did not follow assigned intervention depending on the operator’s decision because the SQ layer was either too thick or too thin, and were excluded from per-protocol [PP] analysis (case 69, control 79). In ITT cohort, the frequency of cancer surgery (63/79 [79.7%] vs. 64/83 [77.1%]; p=0.683) and surgery time (mean ± standard deviation = 227.7±133.9 minutes vs. 226.7±118.2 minutes; p=0.960) were comparable in the case and control group. Mean wound length was also similar in both groups (case vs. control; 24.2 cm vs. 24.3 cm; p=0.933). There were no significant differences in the incidence of wound dehiscence at 4 weeks post-surgery (1/79 [1.3%] vs. 2/83 [2.4%]; p>0.999), the cumulative incidence of wound dehiscence (7/79 [8.9%] vs. 5/83 [6.0%]; p=0.491), and the cumulative incidence of wound infection (1/79 [1.3%] vs. 0/83 [0.0%]; p=0.488) between case and control group. PP analysis showed similar result to ITT analysis. Conclusion: SQ drain insertion did not decrease wound dehiscence and infection in patients who underwent midline laparotomy for gynecological disease.