Urology Division, Hartford Healthcare Medical Group, Hartford Hospital, Hartford, CT.
Urology Division, Hartford Healthcare Medical Group, Hartford Hospital, Hartford, CT.
Urology. 2023 Mar;173:104-110. doi: 10.1016/j.urology.2022.12.002. Epub 2022 Dec 19.
To assess the effectiveness of a peritoneal flap on the formation of lymphoceles after robotic assisted radical prostatectomy with bilateral extended pelvic lymph node dissection.
We conducted a single surgeon, assessor blinded prospective randomized controlled trial (the Prospective Lymphocele Ultrasound Study) in men undergoing robotic assisted radical prostatectomy with bilateral extended pelvic lymph node dissection. At the conclusion of the node dissection, patients were block randomized 1:1 to either standard of care (no bladder peritoneal flap) or to the creation of a bladder peritoneal flap. Lymphocele formation was assessed by pelvic ultrasound postoperatively. The primary outcome was lymphocele formation. Rates of lymphocele formation and complications were analyzed using chi-square. Other outcomes, including length of stay, number of lymph nodes removed, lymphocele volume, and quality of life measures, were analyzed by t-tests or Wilcoxon Ranked Sum Tests, as appropriate. An a priori power calculation was performed using O'Brien-Fleming alpha sharing for the interim analyses. Two preplanned interim analyses were performed when 45 and 90 patients per group had follow-up ultrasounds.
A statistically significant difference in lymphocele formation was seen on the second interim analysis for 183 patients (4.3% vs. 15.6%, p = .011) stopping enrollment; this remained significant in the final analysis of 216 patients (3.6% vs 14.2%, p = .006). No other significant differences were observed.
This prospective randomized trial supports the implementation of this simple modification for robotic assisted radical prostatectomy with bilateral extended pelvic lymph node dissection.
评估机器人辅助根治性前列腺切除术联合双侧广泛盆腔淋巴结清扫术后腹膜瓣对淋巴囊肿形成的效果。
我们进行了一项由单名外科医生进行、评估员设盲的前瞻性随机对照试验（前瞻性淋巴囊肿超声研究），纳入接受机器人辅助根治性前列腺切除术联合双侧广泛盆腔淋巴结清扫术的男性患者。在完成淋巴结清扫后，患者按照 1:1 比例进行分组，随机分为标准治疗组（无膀胱腹膜瓣）或膀胱腹膜瓣组。术后通过盆腔超声评估淋巴囊肿形成情况。主要结局为淋巴囊肿形成。采用卡方检验分析淋巴囊肿形成率和并发症发生率。采用 t 检验或 Wilcoxon 秩和检验分析其他结局，包括住院时间、切除的淋巴结数量、淋巴囊肿体积和生活质量评估。使用 O'Brien-Fleming α 共享法进行了预先设定的中期分析的效能计算。当每组有 45 例和 90 例患者接受了随访超声检查时，进行了两次中期分析。
在 183 例患者的第二次中期分析中，腹膜瓣组的淋巴囊肿形成率为 4.3%，而标准治疗组为 15.6%，差异具有统计学意义（p=0.011），停止入组；在最终的 216 例患者的分析中，腹膜瓣组的淋巴囊肿形成率为 3.6%，标准治疗组为 14.2%，差异仍具有统计学意义（p=0.006）。未观察到其他显著差异。
这项前瞻性随机试验支持对机器人辅助根治性前列腺切除术联合双侧广泛盆腔淋巴结清扫术实施这种简单的改良。
