Department of Obstetrics and Gynecology, Sungkyunkwan University School of Medicine, Samsung Seoul Hospital, Seoul, South Korea.
Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, South Korea.
Eur J Surg Oncol. 2024 Sep;50(9):108484. doi: 10.1016/j.ejso.2024.108484. Epub 2024 Jun 12.
To identify the effects of subcutaneous drain insertion on wound dehiscence and infection in patients who underwent gynecological midline laparotomy.
This analysis identified the secondary endpoints of the KGOG 4001 study, a prospective, multicenter, non-blind, randomized controlled trial. Patients scheduled to undergo midline laparotomy for gynecological diseases and, with body mass index<35 kg/m, were randomized (1:1) to treatment (with subcutaneous drain) and control (without subcutaneous drain) groups from February 2021 to December 2021. We compared the incidence rate of wound dehiscence 4 weeks post-surgery and the cumulative incidence rate of wound dehiscence and infection up to 4 weeks post-surgery between the two groups.
Of 174 patients randomized to the treatment (n = 84) and control (n = 90) groups, 12 were excluded owing to loss to follow-up; finally, 162 patients (treatment, n = 79; control, n = 83) were included in intention-to-treat analysis. The frequency of cancer surgery (79.7 % vs. 77.1 %, p = 0.683), mean surgery time (227.7 vs. 226.7 min, p = 0.960), and mean wound length (24.2 vs. 24.3 cm, p = 0.933) were comparable between two groups. No significant differences were observed in the incidence rate of wound dehiscence 4 weeks post-surgery (1.3 % vs. 2.4 %, p > 0.999), cumulative incidence rate of wound dehiscence (8.9 % vs. 6.0 %, p = 0.491), and cumulative incidence rate of wound infection (1.3 % vs. 0.0 %, p = 0.488) up to 4 weeks post-surgery between the two groups.
Subcutaneous drain insertion is not associated with a significant improvement in the incidence of wound dehiscence and infection in patients who undergo gynecological midline laparotomy.
ClinicalTrials.gov, NCT04643197.
确定妇科正中剖腹术后皮下引流对切口裂开和感染的影响。
本分析确定了 KGOG 4001 研究的次要终点，该研究是一项前瞻性、多中心、非盲、随机对照试验。2021 年 2 月至 2021 年 12 月，计划接受妇科正中剖腹术治疗且体重指数<35 kg/m²的妇科疾病患者，按 1:1 随机分为治疗（皮下引流）和对照组（无皮下引流）。我们比较了两组患者术后 4 周的切口裂开发生率和术后 4 周内切口裂开和感染的累积发生率。
174 例随机分为治疗组（n=84）和对照组（n=90）的患者中，12 例因失访而被排除；最终，162 例患者（治疗组，n=79；对照组，n=83）纳入意向治疗分析。癌症手术的比例（79.7% vs. 77.1%，p=0.683）、平均手术时间（227.7 分钟 vs. 226.7 分钟，p=0.960）和平均切口长度（24.2 厘米 vs. 24.3 厘米，p=0.933）在两组间无显著差异。术后 4 周的切口裂开发生率（1.3% vs. 2.4%，p>0.999）、切口裂开累积发生率（8.9% vs. 6.0%，p=0.491）和术后 4 周内切口感染累积发生率（1.3% vs. 0.0%，p=0.488）在两组间无显著差异。
妇科正中剖腹术后皮下引流不能显著降低切口裂开和感染的发生率。
ClinicalTrials.gov，NCT04643197。
