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腹腔镜与开放式Burch阴道悬吊术:一项随机对照试验。

Laparoscopic versus open Burch colposuspension: a randomised controlled trial.

作者信息

Carey M P, Goh J T, Rosamilia A, Cornish A, Gordon I, Hawthorne G, Maher C F, Dwyer P L, Moran P, Gilmour D T

机构信息

Department of Urogynaecology at Royal Women's Hospital, Melbourne, Australia.

出版信息

BJOG. 2006 Sep;113(9):999-1006. doi: 10.1111/j.1471-0528.2006.01037.x.

Abstract

OBJECTIVE

To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence.

DESIGN

Randomised surgical trial with single blinding.

SETTING

Three tertiary level teaching hospitals involving seven surgeons of varying skill levels.

POPULATION

Two hundred women with urodynamic stress incontinence (USI).

METHODS

The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience.

MAIN OUTCOME MEASURES

Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living.

RESULTS

There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P< 0.0001) but was associated with less blood loss (P = 0.03), less pain (P = 0.02), and quicker return to normal activities (P = 0.01).

CONCLUSION

LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes. To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence. Randomised surgical trial with single blinding. Three tertiary level teaching hospitals involving seven surgeons of varying skill levels. Two hundred women with urodynamic stress incontinence (USI). The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience. Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living. There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P < 0.0001) but was associated with less blood loss (P= 0.03), less pain (P= 0.02), and quicker return to normal activities (P= 0.01). LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes.

摘要

目的

比较腹腔镜Burch阴道悬吊术(LBC)和开放式Burch阴道悬吊术(OBC)治疗压力性尿失禁的围手术期特征、短期和长期疗效。

设计

单盲随机外科试验。

地点

三家三级教学医院,涉及七名技能水平各异的外科医生。

研究对象

200名患有尿动力学压力性尿失禁(USI)的女性。

方法

两组治疗方式相同,只是手术方式分别为腹腔镜手术或开放手术。尝试对受试者和收集结果数据的观察者隐瞒治疗组信息。分析针对外科医生的经验进行了调整。

主要观察指标

术后6个月无USI、术后疼痛、住院时间以及恢复正常日常生活活动的时间。

结果

在随访6个月、24个月或3 - 5年时,腹腔镜和开放式阴道悬吊术组在客观和主观治愈指标以及患者满意度方面均无显著差异。腹腔镜阴道悬吊术的手术时间更长(87分钟对42分钟,P<0.0001),但出血量更少(P = 0.03),疼痛更轻(P = 0.02),恢复正常活动更快(P = 0.01)。

结论

与传统的开放式Burch阴道悬吊术相比,腹腔镜Burch阴道悬吊术具有显著优势,且在短期和长期疗效方面没有明显的妥协。为比较腹腔镜Burch阴道悬吊术(LBC)和开放式Burch阴道悬吊术(OBC)治疗压力性尿失禁的围手术期特征、短期和长期疗效。单盲随机外科试验。三家三级教学医院,涉及七名技能水平各异的外科医生。200名患有尿动力学压力性尿失禁(USI)的女性。两组治疗方式相同,只是手术方式分别为腹腔镜手术或开放手术。尝试对受试者和收集结果数据的观察者隐瞒治疗组信息。分析针对外科医生的经验进行了调整。术后6个月无USI、术后疼痛、住院时间以及恢复正常日常生活活动的时间。在随访6个月、24个月或3 - 5年时,腹腔镜和开放式阴道悬吊术组在客观和主观治愈指标以及患者满意度方面均无显著差异。腹腔镜阴道悬吊术的手术时间更长(87分钟对42分钟,P < 0.0001),但出血量更少(P=0.03),疼痛更轻(P=0.02),恢复正常活动更快(P=0.01)。与传统的开放式Burch阴道悬吊术相比,腹腔镜Burch阴道悬吊术具有显著优势,且在短期和长期疗效方面没有明显的妥协。

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