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子宫切除术后的阴道、性及泌尿系统症状:一项多中心随机对照试验

Vaginal, sexual and urinary symptoms following hysterectomy: a multi-centre randomized controlled trial.

作者信息

Ekanayake Chanil, Pathmeswaran Arunasalam, Herath Rasika, Wijesinghe Prasantha

机构信息

1Department of Clinical Sciences, Faculty of Medicine, General Sir John Kotelawala Defence University, Ratmalana, Sri Lanka.

2Department of Public Health, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.

出版信息

Womens Midlife Health. 2020 Mar 2;6:1. doi: 10.1186/s40695-020-0049-2. eCollection 2020.

Abstract

BACKGROUND

Hysterectomy is the most common major gynaecological procedure. The aim of this study was to study vaginal, sexual and urinary symptoms following total abdominal hysterectomy (TAH), non-descent vaginal hysterectomy (NDVH) and total laparoscopic hysterectomy (TLH) in a low resource setting.

METHODS

A multi-centre randomized controlled trial (RCT) was conducted in two public sector hospitals in Sri Lanka. Participants were patients requiring hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus> 14 weeks, previous pelvic surgery, medical illnesses which contraindicated laparoscopic surgery, and those requiring incontinence surgery or pelvic floor surgery.Vaginal, sexual function and urinary symptoms were assessed by the validated translations of ICIQ-VS and ICIQ-FLUTS questionnaires. Post-operative improvement (pre-operative - post-operative) was assessed.

RESULTS

There was an improvement (median (IQ1-IQ3) in vaginal symptoms [TAH 6(2-8) vs 4(0-8),  < 0.001; NDVH 6(4-8.5) vs 5(0-8), p < 0.001; TLH 4(2-10.5) vs 4(0-10), p < 0.001], urinary flow symptoms [TAH 2(1-4) vs 1 (0-3), p < 0.001; NDVH 3 (2-5) vs 2 (0.5-4), p < 0.001; TLH 1(1-4) vs 1(0-3),  < 0.05], urinary voiding symptoms [TAH 0(0-0) vs 0(0-0),  = 0.20; NDVH 0(0-1) vs 0(0-0.8),  < 0.05; TLH 0(0-0) vs 0(0-0), p < 0.05] and urinary incontinence symptoms [TAH 0(0-2) vs 0(0-2),  = 0.06; NDVH 0(0-3) vs 0(0-3),  < 0.001; TLH 0(0-3) vs 0(0-2),  < 0.05] at 1-year (TAH  = 47, NDVH  = 45, TLH n = 47). There was an improvement in sexual symptoms only in the TLH group [TAH 0(0-11.5) vs 0(0-14),  = 0.08); NDVH 0(0-0) vs 0(0-0),  = 0.46; TLH 0(0-0) vs 0(0-4), p < 0.05].There was no significant difference among the three different routes in terms of vaginal symptoms score [TAH 2 (0-2), NDVH 0 (0-2), TLH 0 (0-2),  = 0.33], sexual symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0),  = 0.52], urinary flow symptoms [TAH 0 (0-1), NDVH 0 (0-1), TLH 0 (0-2),  = 0.56], urinary voiding symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0),  = 0.64] and urinary incontinence symptoms [TAH 0 (0-0), NDVH 0 (0-1), TLH 0 (0-1),  = 0.35] at 1-year.

CONCLUSIONS

There was a post-operative improvement in vaginal symptoms and urinary symptoms in all three groups. There was no significant difference in pelvic organ symptoms between the three routes; TAH, NDVH and TLH.

TRIAL REGISTRATION

Sri Lanka clinical trials registry, SLCTR/2016/020 and the International Clinical Trials Registry Platform, U1111-1194-8422, on 26 July 2016. Available from: http://slctr.lk/trials/515.

摘要

背景

子宫切除术是最常见的大型妇科手术。本研究的目的是在资源匮乏地区研究经腹全子宫切除术(TAH)、非脱垂阴道子宫切除术(NDVH)和全腹腔镜子宫切除术(TLH)后的阴道、性和泌尿系统症状。

方法

在斯里兰卡的两家公立医院进行了一项多中心随机对照试验(RCT)。参与者为因非恶性子宫原因需要进行子宫切除术的患者。排除标准为子宫>14周、既往盆腔手术史、有腹腔镜手术禁忌的内科疾病,以及需要进行尿失禁手术或盆底手术的患者。通过ICIQ-VS和ICIQ-FLUTS问卷的有效翻译版本评估阴道、性功能和泌尿系统症状。评估术后改善情况(术前-术后)。

结果

1年后,三组患者的阴道症状[TAH组:6(2-8)对4(0-8),p<0.001;NDVH组:6(4-8.5)对5(0-8),p<0.001;TLH组:4(2-10.5)对4(0-10),p<0.001]、尿流症状[TAH组:2(1-4)对1(0-3),p<0.001;NDVH组:3(2-5)对2(0.5-4),p<0.001;TLH组:1(1-4)对1(0-3),p<0.05]、排尿症状[TAH组:0(0-0)对0(0-0),p=0.20;NDVH组:0(0-1)对0(0-0.8),p<0.05;TLH组:0(0-0)对0(0-0),p<0.05]和尿失禁症状[TAH组:0(0-2)对0(0-2),p=0.06;NDVH组:0(0-3)对0(0-3),p<0.001;TLH组:0(0-3)对0(0-2),p<0.05]均有改善(TAH组n=47,NDVH组n=45,TLH组n=47)。仅TLH组的性症状有改善[TAH组:0(0-11.5)对0(0-14),p=0.08;NDVH组:0(0-0)对0(0-0),p=0.46;TLH组:0(0-0)对0(0-4),p<0.05]。在1年时,三种不同手术途径在阴道症状评分[TAH组:2(0-2),NDVH组:0(0-2),TLH组:0(0-2),p=0.33]、性症状[TAH组:0(0-0),NDVH组:0(0-0),TLH组:0(0-0),p=0.52]、尿流症状[TAH组:0(0-1),NDVH组:0(0-1),TLH组:0(0-2),p=0.56]、排尿症状[TAH组:0(0-0),NDVH组:0(0-0),TLH组:0(0-0),p=0.64]和尿失禁症状[TAH组:0(0-0),NDVH组:0(0-1),TLH组:0(0-1),p=0.35]方面无显著差异。

结论

所有三组患者术后阴道症状和泌尿系统症状均有改善。TAH、NDVH和TLH这三种手术途径在盆腔器官症状方面无显著差异。

试验注册

斯里兰卡临床试验注册中心,SLCTR/2016/020,以及国际临床试验注册平台,U1111-1194-8422,于2016年7月26日注册。可从以下网址获取:http://slctr.lk/trials/515

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0f1/7052959/c3c2fe003774/40695_2020_49_Fig1_HTML.jpg

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