Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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%; P = .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.
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov: NCT01407263.
UNASSIGNED: 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.
UNASSIGNED: 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%; P = .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.
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov: NCT01407263.
摘要：
■切口疝是机器人根治性前列腺切除术后的常见并发症。接受机器人前列腺切除术的男性的观察数据表明，横向闭合比垂直闭合导致更低的疝发生率。我们试图比较垂直和横向拔除部位闭合后机器人根治性前列腺切除术后切口疝的发生率。
■我们进行了临床整合，交叉，在一个三级转诊中心(2016年1月-2021年9月)进行的整群随机试验,比较了1356例接受微创根治性前列腺切除术的患者行横向和垂直摘除部位切除术后的疝发生率.主要结果是通过体格检查和自我报告的患者调查定义的前列腺切除术后15个月内切口疝的组间发生率。
■总的来说，197例（20%）患者在15个月内出现切口疝，797在此期间没有切口疝，362例患者的切口疝结局数据缺失.我们发现两种切口类型之间的疝发生率没有显着差异（绝对组间差异1.8％;95％CI-3.4％，6.6%；P=.5)在初步分析或3次敏感性分析中。值得注意的是,因为使用了疝气的包容性定义，这些数据不能用于估计切口疝的真实患病率.
■外科医生在提取标本时应选择他们最舒适的切口和闭合方法。对手术技术的修改研究最好以随机比较的方式进行，和临床整合，交叉，整群随机试验允许大型试验在单个中心以低成本完成.
■ClinicalTrials.gov：NCT01407263。
■我们进行了临床整合，交叉，在一个三级转诊中心(2016年1月-2021年9月)进行的整群随机试验,比较了1356例接受微创根治性前列腺切除术的患者行横向和垂直摘除部位切除术后的疝发生率.主要结果是通过体格检查和自我报告的患者调查定义的前列腺切除术后15个月内切口疝的组间发生率。
■总的来说，197例（20%）患者在15个月内出现切口疝，797在此期间没有切口疝，362例患者的切口疝结局数据缺失.我们发现两种切口类型之间的疝发生率没有显着差异（绝对组间差异1.8％;95％CI-3.4％，6.6%；P=.5)在初步分析或3次敏感性分析中。值得注意的是,因为使用了疝气的包容性定义，这些数据不能用于估计切口疝的真实患病率.
■外科医生在提取标本时应选择他们最舒适的切口和闭合方法。对手术技术的修改研究最好以随机比较的方式进行，和临床整合，交叉，整群随机试验允许大型试验在单个中心以低成本完成.
■ClinicalTrials.gov：NCT01407263。
