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腹腔镜与机器人骶骨阴道固定术治疗阴道脱垂的比较:一项随机对照试验。

Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial.

机构信息

From the Cleveland Clinic, Cleveland, Ohio.

出版信息

Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c.

Abstract

OBJECTIVE

To compare conventional laparoscopic and robotic-assisted laparoscopic sacrocolpopexy for vaginal apex prolapse.

METHODS

This single-center, blinded randomized trial included participants with stage 2-4 posthysterectomy vaginal prolapse. Participants were randomized to laparoscopic or robotic sacrocolpopexy. The primary outcome was total operative time from incision to closure. Secondary outcomes were postoperative pain, functional activity, bowel and bladder symptoms, quality of life, anatomic vaginal support, and cost from a health care system perspective.

RESULTS

A total of 78 patients enrolled and were randomized (laparoscopic n=38; robotic n=40). Total operative time was significantly longer in the robotic group compared with the laparoscopic group (+67-minute difference; 95% confidence interval [CI] 43-89; P<.001). Anesthesia time, total time in the operating room, total sacrocolpopexy time, and total suturing time were all significantly longer in the robotic group. Participants in the robotic group also had significantly higher pain at rest and with activity during weeks 3 through 5 after surgery and required longer use of nonsteroidal anti-inflammatory drugs (median, 20 compared with 11 days, P<.005). The robotic group incurred greater cost than the laparoscopic group (mean difference +$1,936; 95% CI $417-$3,454; P=.008). Both groups demonstrated significant improvement in vaginal support and functional outcomes 1 year after surgery with no differences between groups.

CONCLUSION

Robotic-assisted sacrocolpopexy results in longer operating time and increased pain and cost compared with the conventional laparoscopic approach.

摘要

目的

比较传统腹腔镜与机器人辅助腹腔镜骶骨阴道固定术治疗阴道顶端脱垂。

方法

本单中心、盲法随机试验纳入了 2 型至 4 型经子宫切除术后阴道脱垂患者。参与者被随机分配至腹腔镜或机器人骶骨阴道固定术组。主要结局是从切口到缝合的总手术时间。次要结局包括术后疼痛、功能活动、肠和膀胱症状、生活质量、阴道解剖支持以及从医疗保健系统角度的成本。

结果

共有 78 名患者入组并被随机分组(腹腔镜组 38 例,机器人组 40 例)。机器人组的总手术时间明显长于腹腔镜组(差异 67 分钟;95%置信区间 [CI] 43-89;P<.001)。机器人组的麻醉时间、手术室总时间、骶骨阴道固定总时间和总缝合时间均明显更长。机器人组术后 3 至 5 周的静息和活动时疼痛明显更高,且需要更长时间使用非甾体抗炎药(中位数 20 天比 11 天,P<.005)。机器人组的成本明显高于腹腔镜组(平均差异 +$1936;95%CI $417-$3454;P=.008)。两组在术后 1 年时阴道支持和功能结局均显著改善,但组间无差异。

结论

与传统腹腔镜方法相比,机器人辅助骶骨阴道固定术的手术时间更长,疼痛和成本更高。

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