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空气密封系统在良性疾病腹腔镜子宫切除术中的益处:一项随机对照试验

Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: A Randomized Controlled Trial.

作者信息

Delecourt Camille, Tourette Claire, Crochet Patrice, Pivano Audrey, Hamouda Ilyes, Agostini Aubert

机构信息

Service de Gynécologie Obstétrique, Hôpital Nord, Gynépôle, Assistance publique des Hôpitaux de Marseille, Chemin des Bourelly (Dr. Delecourt).

Service de Gynécologie Obstétrique, Hôpital de la Conception, Gynépôle, Assistance publique des Hôpitaux de Marseille, Boulevard Baille (Drs. Tourette, Pivano, and Agostini).

出版信息

J Minim Invasive Gynecol. 2022 Aug;29(8):1003-1010. doi: 10.1016/j.jmig.2022.05.005. Epub 2022 May 13.

DOI:10.1016/j.jmig.2022.05.005
PMID:35569811
Abstract

STUDY OBJECTIVE

To compare the AirSeal insufflation system with the standard insufflation system for postoperative abdominal pain after laparoscopic hysterectomy for benign pathology.

DESIGN

Randomized controlled trial.

SETTING

Teaching Hospital La Conception, Marseille, France, February 2018 to July 2020.

PATIENTS

A total of 80 patients scheduled for a laparoscopic hysterectomy for benign pathology (40 per group).

INTERVENTION

Laparoscopic hysterectomy using the AirSeal insufflation system with a pneumoperitoneum between 8 and 10 mm Hg compared with the standard insufflation system with a pneumoperitoneum between 12 and 15 mm Hg.

MEASUREMENTS AND MAIN RESULTS

The primary end point was abdominal pain at 6 hours after the end of surgery, assessed by a Simple Numerical Scale from 0 to 10. The secondary end points were intraoperative (operating time and difficulty of the surgery felt by the operator), early postoperative (intensity of abdominal and scapular pain at H0 [end of surgery], H2 [two hours after the end of surgery, H12 [twelve hour after the end of surgery], H24 [twenty four hours after the end of surgery], H48 [fourty eight hours after the end of surgery]), and late postoperative (late postoperative complication, estimated time to return to normal life, and overall patient satisfaction assessed by the SF-12 general health survey). The median values for abdominal pain were not different between the 2 groups at 6 hours (AirSeal group median, 0; interquartile range, 2 vs standard laparoscopy group median, 1; interquartile range, 2; p = .41). The abdominal and scapular pain values were similar in both groups at all postoperative times. There were no differences between the groups regarding secondary end points.

CONCLUSION

Use of the AirSeal insufflation system with low-pressure pneumoperitoneum in laparoscopic hysterectomy for a benign indication did not reduce postoperative abdominal and scapular pain.

摘要

研究目的

比较用于良性病变腹腔镜子宫切除术后腹痛的AirSeal气腹系统和标准气腹系统。

设计

随机对照试验。

地点

法国马赛拉孔塞ption教学医院,2018年2月至2020年7月。

患者

共有80例计划进行良性病变腹腔镜子宫切除术的患者(每组40例)。

干预措施

使用AirSeal气腹系统进行腹腔镜子宫切除术,气腹压力维持在8至10 mmHg,与标准气腹系统(气腹压力维持在12至15 mmHg)进行比较。

测量指标及主要结果

主要终点为手术结束后6小时的腹痛情况,采用0至10的简单数字评分法进行评估。次要终点包括术中(手术时间和术者感受的手术难度)、术后早期(术后0小时[手术结束时]、术后2小时、术后12小时、术后24小时、术后48小时的腹部和肩部疼痛强度)以及术后晚期(术后晚期并发症、估计恢复正常生活的时间以及通过SF-​12一般健康调查评估的患者总体满意度)。两组在6小时时腹痛的中位数无差异(AirSeal组中位数为0;四分位间距为2,而标准腹腔镜组中位数为1;四分位间距为2;p = 0.41)。两组在所有术后时间点的腹部和肩部疼痛值相似。两组在次要终点方面无差异。

结论

在良性病变的腹腔镜子宫切除术中使用低压气腹的AirSeal气腹系统并不能减轻术后腹部和肩部疼痛。

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