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妇科腹腔镜检查中辅助端口尺寸的最小化:一项随机试验。

Minimizing ancillary ports size in gynecologic laparoscopy: a randomized trial.

作者信息

Ghezzi Fabio, Cromi Antonella, Colombo Giacomo, Uccella Stefano, Bergamini Valentino, Serati Maurizio, Bolis Pierfrancesco

机构信息

Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy.

出版信息

J Minim Invasive Gynecol. 2005 Nov-Dec;12(6):480-5. doi: 10.1016/j.jmig.2005.09.002.

Abstract

STUDY OBJECTIVE

To evaluate the feasibility, safety, and effect on postoperative pain of laparoscopy for the management of adnexal masses by downsizing ancillary trocars from 5- to 3-mm.

DESIGN

Randomized, controlled trial (Canadian Task Force classification I).

SETTING

Gynecologic department of a university hospital

PATIENTS

A total of 102 women with an adnexal mass scheduled for gynecologic laparoscopic procedures were randomized to undergo laparoscopy using either conventional 5-mm ancillary trocars (n=52) or 3-mm instruments (n=50). Preoperative suspicion of malignancy, deep infiltrating endometriosis, and indications for hysterectomy or myomectomy were considered as exclusion criteria.

INTERVENTIONS

Laparoscopic procedures for the treatment of benign adnexal masses.

MEASUREMENTS AND MAIN RESULTS

Both groups were similar in patient age, body mass index, history of abdominal surgery, and type of procedures. Intraoperative complications occurred in no patient (0%) in the 3-mm group and in two patients (3.8%) in the 5-mm group (p=.49). Conversion from 3- to 5-mm instrumentation was necessary in one procedure. No difference was found in the operative time between the 3-mm and the 5-mm groups (54 min [range 15-175 min] vs 50 min [range 20-150 min], p=.89). The severity of incisional pain was evaluated with a 100-mm visual analog scale at 1, 3, and 24 hours after surgery. Postoperative pain was significantly lower in the 3-mm than in the 5-mm group 1 hour after laparoscopy (20 [range 0-60] vs 32.5 [range 0-80], p=.04). The proportion of women requiring analgesia before discharge, the timing of analgesic requirement, and the total amount of medication in the first 24 hours after surgery were similar in the two groups.

CONCLUSION

Three-millimeter ancillary trocars can safely replace traditional-size equipment for the management of adnexal masses without a negative impact on the surgeon's ability to perform gynecologic laparoscopy and are associated with less immediate postoperative pain.

摘要

研究目的

通过将辅助套管针从5毫米缩小至3毫米,评估腹腔镜检查用于附件肿块治疗的可行性、安全性及对术后疼痛的影响。

设计

随机对照试验(加拿大工作组分类I级)。

地点

一所大学医院的妇科

患者

共有102例计划接受妇科腹腔镜手术的附件肿块女性患者,被随机分为两组,一组使用传统的5毫米辅助套管针进行腹腔镜检查(n = 52),另一组使用3毫米器械(n = 50)。术前怀疑恶性肿瘤、深部浸润性子宫内膜异位症以及子宫切除术或肌瘤切除术指征被视为排除标准。

干预措施

腹腔镜手术治疗良性附件肿块。

测量指标及主要结果

两组患者在年龄、体重指数、腹部手术史和手术类型方面相似。3毫米组无患者发生术中并发症(0%),5毫米组有2例患者发生术中并发症(3.8%)(p = 0.49)。有1例手术需要从3毫米器械转换为5毫米器械。3毫米组和5毫米组的手术时间无差异(54分钟[范围15 - 175分钟] vs 50分钟[范围20 - 150分钟],p = 0.89)。术后1小时、3小时和24小时,采用100毫米视觉模拟评分法评估切口疼痛的严重程度。腹腔镜检查后1小时,3毫米组的术后疼痛明显低于5毫米组(20[范围0 - 60] vs 32.5[范围0 - 80];p = 0.04)。两组中出院前需要镇痛的女性比例、镇痛需求时间以及术后24小时内的药物总量相似。

结论

3毫米辅助套管针可安全替代传统尺寸设备用于附件肿块的治疗,对术者进行妇科腹腔镜手术的能力无负面影响,且术后即时疼痛较轻。

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