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机器人经肛内镜前列腺切除术与经肛微创前列腺切除术评估:REVEAL 多中心随机临床试验。

Robotic eTEP versus IPOM evaluation: the REVEAL multicenter randomized clinical trial.

机构信息

Department of Surgery, Center for Abdominal Core Health, Lerner College of Medicine, Cleveland Clinic Foundation, 9500 Euclid Ave. A-100, Cleveland, OH, 44195, USA.

Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

出版信息

Surg Endosc. 2023 Mar;37(3):2143-2153. doi: 10.1007/s00464-022-09722-9. Epub 2022 Nov 2.

DOI:10.1007/s00464-022-09722-9
PMID:36323978
Abstract

BACKGROUND

For small to medium-sized ventral hernias, robotic intraperitoneal onlay mesh (rIPOM) and enhanced-view totally extraperitoneal (eTEP) repair have emerged as acceptable approaches that each takes advantage of robotic instrumentation. We hypothesized that avoiding mesh fixation in a robotic eTEP repair offers an advantage in early postoperative pain compared to rIPOM.

METHODS

This is a multi-center, randomized clinical trial for patients with midline ventral hernias ≤ 7 cm, who were randomized to rIPOM or robotic eTEP. The primary outcome was pain (0-10) on the first postoperative day. Secondary outcomes included same-day discharge, length of stay, opioid consumption, quality of life, surgeon workload, and cost.

RESULTS

Between November 2019 and November 2021, 100 patients were randomized (49 rIPOM, 51 eTEP) among 5 surgeons. Pain on the first postoperative day [median (IQR): 5 (4-6) vs. 5 (3.5-7), p = 0.66] was similar for rIPOM and eTEP, respectively, a difference maintained following adjustments for surgeon, operative time, baseline pain, and patient co-morbidities (difference 0.28, 95% CI - 0.63 to 1.19, p = 0.56). No differences in pain on the day of surgery, 7, and 30 days after surgery were identified. Same-day discharge, length of stay, opioid consumption, and 30-day quality of life were also comparable, though rIPOM required less surgeon workload (p < 0.001), shorter operative time [107 (86-139) vs. 165 (129-212) min, p < 0.001], and resulted in fewer surgical site occurrences (0 vs. 8, p = 0.004). The total direct costs for rIPOM and eTEP were comparable [$8282 (6979-11835) vs. $8680 (7550-10282), p = 0.52] as the cost savings for eTEP attributable to mesh use [$442 (434-485) vs. $69 (62-76), p =  < 0.0001] were offset by increased expenses for operative time [$669 (579-861) vs. $1075 (787-1367), p < 0.0001] and use of more robotic equipment [$760 (615-933) vs. $946 (798-1203), p = 0.001].

CONCLUSION

The avoidance of fixation in a robotic eTEP repair did not reveal a benefit in postoperative pain to offset the shorter operative time and surgeon workload offered by rIPOM.

摘要

背景

对于中小型的腹侧疝,机器人腹腔内补片(rIPOM)和增强型完全腹膜外(eTEP)修复已成为可接受的方法,每种方法都利用了机器人器械。我们假设在机器人 eTEP 修复中避免补片固定可以在术后早期疼痛方面优于 rIPOM。

方法

这是一项针对中线腹侧疝 ≤ 7cm 的多中心随机临床试验,患者被随机分为 rIPOM 或机器人 eTEP 组。主要结局是术后第 1 天的疼痛(0-10)。次要结局包括当天出院、住院时间、阿片类药物消耗、生活质量、外科医生工作量和成本。

结果

2019 年 11 月至 2021 年 11 月,5 名外科医生对 100 名患者进行了随机分组(49 名 rIPOM,51 名 eTEP)。rIPOM 和 eTEP 组术后第 1 天的疼痛[中位数(IQR):5(4-6)与 5(3.5-7),p = 0.66]相似,分别在调整外科医生、手术时间、基线疼痛和患者合并症后仍保持不变(差异 0.28,95%CI - 0.63 至 1.19,p = 0.56)。在手术当天、术后 7 天和 30 天,疼痛没有差异。当天出院、住院时间、阿片类药物消耗和 30 天生活质量也相似,尽管 rIPOM 需要的外科医生工作量较少(p < 0.001),手术时间更短[107(86-139)与 165(129-212)min,p < 0.001],并且手术部位并发症更少(0 与 8,p = 0.004)。rIPOM 和 eTEP 的总直接成本相当[$8282(6979-11835)与 $8680(7550-10282),p = 0.52],因为 eTEP 归因于补片使用的节省成本[$442(434-485)与 $69(62-76),p < 0.0001]被手术时间增加的费用所抵消 [$669(579-861)与 $1075(787-1367),p < 0.0001]和更多机器人设备的使用 [$760(615-933)与 $946(798-1203),p = 0.001]。

结论

在机器人 eTEP 修复中避免固定并不能提供术后疼痛方面的益处,以抵消 rIPOM 提供的更短的手术时间和外科医生工作量。

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