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腹腔镜辅助阴道子宫切除术与小切口剖腹子宫切除术的比较:一项前瞻性、随机、多中心研究。

Laparoscopic-assisted vaginal hysterectomy versus minilaparotomy hysterectomy: a prospective, randomized, multicenter study.

作者信息

Muzii Ludovico, Basile Stefano, Zupi Errico, Marconi Daniela, Zullo Marzio Angelo, Manci Natalina, Bellati Filippo, Angioli Roberto, Benedetti Panici Pierluigi

机构信息

Department of Obstetrics and Gynecology, Campus Bio-Medico University, Rome, Italy.

出版信息

J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):610-5. doi: 10.1016/j.jmig.2007.05.012.

Abstract

STUDY OBJECTIVE

The aim of this study was to compare operative and early postoperative outcomes of laparoscopic-assisted vaginal hysterectomy (LAVH) and minilaparotomy in a randomized clinical trial including patients undergoing total hysterectomy for benign gynecologic disease and having 1 or more of the generally considered contraindications to vaginal route.

DESIGN

Prospective, randomized, multicenter trial (Canadian Task Force classification I).

SETTING

Departments of Gynecology from 3 major university hospitals in Rome.

PATIENTS

Eighty-one patients who were candidates for abdominal hysterectomy.

INTERVENTIONS

Laparoscopic-assisted vaginal hysterectomy and minilaparotomy hysterectomy.

MEASUREMENTS AND MAIN RESULTS

Forty patients were randomized to LAVH and 41 to minilaparotomy. Characteristics of patients and indications for surgery in the 2 arms were comparable. In the minilaparotomy group, complications were as follows: 1 case (2.4%) of delayed laparotomy with 2 units of red blood cell transfusion, 2 cases (4.8%) of wound infection, and 3 cases (7.3%) of fever of unknown origin. No minor or major complications were observed in the LAVH group. Postoperative visual analog scale pain scores at days 1 and 2 were significantly lower in the LAVH group (p <.05). The complication rate between the 2 groups was significantly lower for LAVH (p = .026).

CONCLUSION

Because LAVH was associated with significantly lower early postoperative pain scores and complication rates, in general LAVH should be preferred to minilaparotomy hysterectomy when the vaginal approach cannot be used.

摘要

研究目的

本研究旨在比较腹腔镜辅助阴式子宫切除术(LAVH)与小切口剖腹术的手术及术后早期结局,该研究为一项随机临床试验,纳入因良性妇科疾病接受全子宫切除术且存在1项或多项通常被认为是经阴道手术禁忌证的患者。

设计

前瞻性、随机、多中心试验(加拿大工作组分类I级)。

地点

罗马3家主要大学医院的妇科。

患者

81例拟行腹式子宫切除术的患者。

干预措施

腹腔镜辅助阴式子宫切除术和小切口剖腹子宫切除术。

测量指标及主要结果

40例患者被随机分配至LAVH组,41例被分配至小切口剖腹术组。两组患者的特征及手术指征具有可比性。小切口剖腹术组的并发症如下:1例(2.4%)延迟剖腹术伴输注2单位红细胞,2例(4.8%)伤口感染,3例(7.3%)不明原因发热。LAVH组未观察到轻微或严重并发症。LAVH组术后第1天和第2天的视觉模拟评分疼痛得分显著更低(p<.05)。LAVH组的两组间并发症发生率显著更低(p = .026)。

结论

由于LAVH术后早期疼痛评分和并发症发生率显著更低,一般而言,当无法采用经阴道途径时,LAVH应优于小切口剖腹子宫切除术。

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