Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA.
Department of General Surgery, Digestive Disease and Surgery Institute, Hillcrest Hospital, The Cleveland Clinic Foundation, 6770 Mayfield Road, Mayfield Heights, OH, 44124, USA.
Hernia. 2019 Dec;23(6):1105-1113. doi: 10.1007/s10029-019-02001-y. Epub 2019 Aug 6.
Laparoscopic totally extraperitoneal inguinal hernia repair (TEP) can be performed using either telescopic (TD) or balloon dissection (BD). The use of a disposable balloon dissector increases the cost of TEP. However, it remains unclear whether BD saves enough time to justify its cost. We hypothesized that BD would consistently save 15 min in operative time. To test this hypothesis, we designed a registry-based randomized controlled trial (RB-RCT) embedded into the Americas Hernia Society Quality Collaborative.
A single-blinded, parallel, RB-RCT was conducted. Adults with inguinal hernias presenting for elective repair were screened. Patients with unilateral hernias deemed fit to undergo TEP were eligible; those with bilateral hernias (BIH) or undergoing open repair were excluded. Individuals were randomized to TD or BD with a disposable device. TEP was performed with synthetic mesh and tacks. Subjects were blinded and followed up for 30 day. Main outcome was operative time.
207 patients were screened: 166 were excluded and 41 were randomized (21 BD, 20 TD). One patient (TD group) was excluded due to the incidental finding of BIH. 40 patients were analyzed (median age 56, median BMI 26 kg/m, 98% males). Hernias were 72% indirect, 17% direct, 10% pantaloon, and 8% recurrent. Other than obesity (26.5% vs. 0, p = 0.018), there were no baseline differences between the groups. Median operative times were similar (TD 43 min, IQR 33-63; BD 46 min, IQR 35-90, p = 0.490). There were 2 seromas and 2 hematomas in the BD group, and none in the TD (p = 0.108).
BD does not consistently result in 15-min time saving during TEP. Use of a disposable balloon dissector can be deferred in the experienced hands.
ClinicalTrials.gov (NCT03276871).
腹腔镜完全腹膜外腹股沟疝修补术（TEP）可使用可伸缩（TD）或球囊解剖（BD）进行。一次性球囊解剖器的使用增加了 TEP 的成本。然而，BD 是否能节省足够的时间来证明其成本的合理性仍不清楚。我们假设 BD 在手术时间上始终能节省 15 分钟。为了验证这一假设，我们设计了一项基于注册的随机对照试验（RB-RCT），并将其嵌入美洲疝学会质量协作组织中。
进行了一项单盲、平行的 RB-RCT。对接受择期修复的单侧腹股沟疝患者进行筛选。符合 TEP 适应证的单侧疝患者有资格参加；双侧疝（BIH）或接受开放修复的患者被排除在外。患者被随机分配到 TD 或 BD 组，使用一次性器械。TEP 使用合成网片和缝合钉进行。受试者被设盲并随访 30 天。主要结局是手术时间。
对 207 名患者进行了筛选：166 名患者被排除在外，41 名患者被随机分组（BD 组 21 名，TD 组 20 名）。1 名患者（TD 组）因意外发现 BIH 而被排除。对 40 名患者进行了分析（中位年龄 56 岁，中位 BMI 26kg/m2，98%为男性）。疝为 72%间接疝，17%直接疝，10%裤型疝，8%复发疝。除肥胖（26.5%比 0，p=0.018）外，两组间无基线差异。中位手术时间相似（TD 组 43 分钟，IQR 33-63；BD 组 46 分钟，IQR 35-90，p=0.490）。BD 组有 2 例血清肿和 2 例血肿，而 TD 组无（p=0.108）。
BD 并不能始终在 TEP 中节省 15 分钟的手术时间。在有经验的医生手中，可以推迟使用一次性球囊解剖器。
ClinicalTrials.gov（NCT03276871）。
