Division of Urology, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
J Urol. 2024 Sep;212(3):401-408. doi: 10.1097/JU.0000000000004066. Epub 2024 Aug 8.
Incisional hernias are a frequent complication following robotic radical prostatectomy. Observational data in men undergoing robotic prostatectomy suggest that transverse closure resulted in lower hernia rates than vertical closure. We sought to compare the incidence of incisional hernia after robotic radical prostatectomy after vertical and transverse extraction site closure.
We conducted a clinically integrated, crossover, cluster randomized trial at a single tertiary referral center (January 2016-September 2021) comparing the rate of hernia after transverse vs vertical extraction site excision in 1356 patients treated with minimally invasive radical prostatectomy. The primary outcome was between-group incidence of incisional hernia within 15 months of prostatectomy defined by physical examination and self-reported patient surveys.
Overall, 197 (20%) patients developed an incisional hernia within 15 months, 797 did not have an incisional hernia within this period, and 362 had missing outcome data regarding incisional hernia. We found no significant difference in hernia rates between the 2 incision types (absolute between-group difference 1.8%; 95% CI -3.4%, 6.6%; = .5) in the primary analysis or in the 3 sensitivity analyses. Notably, because of the inclusive definition of hernia used, these data cannot be used as an estimate of the true prevalence of incisional hernia.
Surgeons should choose the incision and closure approach they are most comfortable with when extracting specimens. Studies of modifications to the surgical technique are best conducted as randomized comparisons, and the clinically integrated, crossover, cluster randomized trial allows large trials to be completed at a single center and at low cost.
ClinicalTrials.gov: NCT01407263.
切口疝是机器人根治性前列腺切除术后的常见并发症。对接受机器人前列腺切除术的男性的观察数据表明，横切闭合导致疝的发生率低于垂直闭合。我们旨在比较机器人根治性前列腺切除术后垂直和横切提取部位闭合后切口疝的发生率。
我们在一家三级转诊中心进行了一项临床综合、交叉、集群随机试验（2016 年 1 月至 2021 年 9 月），比较了 1356 例微创根治性前列腺切除术患者横切与垂直提取部位切除后疝的发生率。主要结局是术后 15 个月内通过体格检查和患者自我报告调查定义的切口疝的组间发生率。
总体而言，197 例（20%）患者在前列腺切除术后 15 个月内发生切口疝，797 例患者在该期间内未发生切口疝，362 例患者的切口疝结局数据缺失。我们在主要分析或 3 项敏感性分析中均未发现 2 种切口类型之间的疝发生率存在显著差异（绝对组间差异 1.8%；95%CI-3.4%，6.6%；=0.5）。值得注意的是，由于使用了包容性的疝定义，这些数据不能作为切口疝真实患病率的估计。
外科医生在提取标本时应选择他们最熟悉的切口和闭合方法。手术技术改良的研究最好作为随机对照进行，而临床综合、交叉、集群随机试验允许在单个中心以较低成本完成大型试验。
ClinicalTrials.gov：NCT01407263。
