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多机构前瞻性随机试验比较单孔与多孔腹腔镜子宫切除术治疗子宫肌瘤或子宫腺肌病的成功率

Multi-institution, Prospective, Randomized Trial to Compare the Success Rates of Single-port Versus Multiport Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis.

作者信息

Kim Tae-Joong, Shin So-Jin, Kim Tae-Hyun, Cho Chi-Heum, Kwon Sang-Hoon, Seong Seok Ju, Song Taejong, Hur Sooyoung, Kim Yong-Man, Lee Shin-Wha, Kim Young Tae, Nam Eun Ji, Kim Yong Beom, Lee Jung Ryeol, Roh Hyun-Jin, Chung Hyewon

机构信息

Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Keimyung University School of Medicine, Daegu, Korea.

出版信息

J Minim Invasive Gynecol. 2015 Jul-Aug;22(5):785-91. doi: 10.1016/j.jmig.2015.02.022. Epub 2015 Mar 7.

Abstract

STUDY OBJECTIVE

To compare the operative outcomes of patients undergoing either single-port or multiport laparoscopic hysterectomy (LH).

METHODS

Two hundred fifty-six women scheduled for LH for symptomatic myoma and/or adenomyosis from 8 tertiary teaching hospitals were randomized to single-port or multiport groups. Primary outcome was conversion and/or complication proportion of the planned procedure to determine whether the success proportion of the single-port approach was not inferior to that of the multiport approach. Secondary outcomes were postoperative pain and operative scar.

RESULTS

Demographic parameters including age, body mass index, parity, and history of vaginal and cesarean delivery were comparable between the 2 groups. The primary outcome of a combined conversion and/or complication rate was similar between the single-port and multiport groups at 8% and 10.3%, respectively. Conversions were similar between the groups with 4% of single-port cases and .8% of multiport cases. Transfusions were the most frequent complication required in 4.0% of single-port cases and 7.9% of multiport cases, with no difference between the groups. Concerning secondary outcomes, postoperative pain score and patient and observer scar assessment were not different between the 2 groups. Although not a specific outcome measure, there was no difference between the groups in blood loss, operative time, and postoperative hospital stay.

CONCLUSION

Single-port LH is not inferior to multiport LH in terms of conversion and/or complications rates, including transfusion. However, the single-port approach did not have any advantage over multiport LH with regard to pain or cosmetic outcomes. These findings were demonstrated by multi-institutional surgeons in Korea.

摘要

研究目的

比较接受单孔或多孔腹腔镜子宫切除术(LH)患者的手术结果。

方法

来自8家三级教学医院的256名因有症状的子宫肌瘤和/或子宫腺肌病计划行LH的女性被随机分为单孔组或多孔组。主要结局是计划手术的中转率和/或并发症发生率,以确定单孔手术的成功率是否不低于多孔手术。次要结局是术后疼痛和手术瘢痕。

结果

两组间的人口统计学参数,包括年龄、体重指数、产次以及阴道分娩和剖宫产史具有可比性。单孔组和多孔组的中转和/或并发症合并发生率的主要结局相似,分别为8%和10.3%。两组间的中转情况相似,单孔组中转率为4%,多孔组为0.8%。输血是最常见的并发症,单孔组发生率为4.0%,多孔组为7.9%,两组间无差异。关于次要结局,两组间术后疼痛评分以及患者和观察者对瘢痕的评估无差异。虽然不是特定的结局指标,但两组间在失血量、手术时间和术后住院时间方面无差异。

结论

就中转率和/或并发症发生率(包括输血)而言,单孔LH并不劣于多孔LH。然而,在疼痛或美容效果方面,单孔手术相对于多孔LH没有任何优势。这些结果由韩国的多机构外科医生证实。

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