{"title":"子宫切除术后阴道、性和泌尿系统症状:一项多中心随机对照试验","authors":"Chanil Ekanayake, Arunasalam Pathmeswaran, Rasika Herath, Prasantha Wijesinghe","doi":"10.1186/s40695-020-0049-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>There was an improvement (median (IQ1-IQ3) in vaginal symptoms [TAH 6(2-8) vs 4(0-8), <i>p</i> < 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), <i>p</i> < 0.05], urinary voiding symptoms [TAH 0(0-0) vs 0(0-0), <i>p</i> = 0.20; NDVH 0(0-1) vs 0(0-0.8), <i>p</i> < 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), <i>p</i> = 0.06; NDVH 0(0-3) vs 0(0-3), <i>p</i> < 0.001; TLH 0(0-3) vs 0(0-2), <i>p</i> < 0.05] at 1-year (TAH <i>n</i> = 47, NDVH <i>n</i> = 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), <i>p</i> = 0.08); NDVH 0(0-0) vs 0(0-0), <i>p</i> = 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), <i>p</i> = 0.33], sexual symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), <i>p</i> = 0.52], urinary flow symptoms [TAH 0 (0-1), NDVH 0 (0-1), TLH 0 (0-2), <i>p</i> = 0.56], urinary voiding symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), <i>p</i> = 0.64] and urinary incontinence symptoms [TAH 0 (0-0), NDVH 0 (0-1), TLH 0 (0-1), <i>p</i> = 0.35] at 1-year.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>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.</p>","PeriodicalId":75330,"journal":{"name":"Women's midlife health","volume":"6 ","pages":"1"},"PeriodicalIF":0.0000,"publicationDate":"2020-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s40695-020-0049-2","citationCount":"9","resultStr":"{\"title\":\"Vaginal, sexual and urinary symptoms following hysterectomy: a multi-centre randomized controlled trial.\",\"authors\":\"Chanil Ekanayake, Arunasalam Pathmeswaran, Rasika Herath, Prasantha Wijesinghe\",\"doi\":\"10.1186/s40695-020-0049-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>There was an improvement (median (IQ1-IQ3) in vaginal symptoms [TAH 6(2-8) vs 4(0-8), <i>p</i> < 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), <i>p</i> < 0.05], urinary voiding symptoms [TAH 0(0-0) vs 0(0-0), <i>p</i> = 0.20; NDVH 0(0-1) vs 0(0-0.8), <i>p</i> < 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), <i>p</i> = 0.06; NDVH 0(0-3) vs 0(0-3), <i>p</i> < 0.001; TLH 0(0-3) vs 0(0-2), <i>p</i> < 0.05] at 1-year (TAH <i>n</i> = 47, NDVH <i>n</i> = 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), <i>p</i> = 0.08); NDVH 0(0-0) vs 0(0-0), <i>p</i> = 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), <i>p</i> = 0.33], sexual symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), <i>p</i> = 0.52], urinary flow symptoms [TAH 0 (0-1), NDVH 0 (0-1), TLH 0 (0-2), <i>p</i> = 0.56], urinary voiding symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), <i>p</i> = 0.64] and urinary incontinence symptoms [TAH 0 (0-0), NDVH 0 (0-1), TLH 0 (0-1), <i>p</i> = 0.35] at 1-year.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>Sri Lanka clinical trials registry, SLCTR/2016/020 and the International Clinical Trials Registry Platform, U1111-1194-8422, on 26 July 2016. 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引用次数: 9
摘要
背景:子宫切除术是最常见的主要妇科手术。本研究的目的是研究低资源环境下全腹部子宫切除术(TAH)、非下降阴道子宫切除术(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:在斯里兰卡两所公立医院进行多中心随机对照试验(RCT)。参与者是因非恶性子宫原因需要子宫切除术的患者。排除标准为子宫> 14周,既往盆腔手术,内科疾病禁忌腹腔镜手术,需要失禁手术或盆底手术。阴道、性功能和泌尿症状通过ICIQ-VS和ICIQ-FLUTS问卷的有效翻译进行评估。评估术后改善情况(术前-术后)。结果:患者阴道症状改善(中位数(IQ1-IQ3)) [TAH 6(2-8) vs 4(0-8), p p p = 0.20;NDVH 0(0-1) vs 0(0-0.8), p p = 0.06;NDVH 0(0 - 3)和0 (0 - 3),p p n = 47岁NDVH n = 45, n = 47子宫切除术)。只有TLH组性症状有所改善[TAH 0(0-11.5) vs 0(0-14), p = 0.08];NDVH 0(0-0) vs 0(0-0), p = 0.46;1年的TLH 0(0-0) vs 0(0-4),性症状[TAH 0(0-0), NDVH 0(0-0), TLH 0(0-0), p = 0.52],尿流症状[TAH 0(0- 1), NDVH 0(0- 1), TLH 0(0- 2), p = 0.56],排尿症状[TAH 0(0-0), NDVH 0(0-0), TLH 0(0-0), p = 0.64]和尿失禁症状[TAH 0(0-0), NDVH 0(0- 1), TLH 0(0- 1), p = 0.35]。结论:三组患者术后阴道症状和泌尿系统症状均有改善。三种途径患者盆腔器官症状差异无统计学意义;TAH, NDVH和TLH。试验注册:斯里兰卡临床试验注册中心,SLCTR/2016/020和国际临床试验注册平台,U1111-1194-8422, 2016年7月26日。可从:http://slctr.lk/trials/515。
Vaginal, sexual and urinary symptoms following hysterectomy: a multi-centre randomized controlled trial.
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), p < 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), p < 0.05], urinary voiding symptoms [TAH 0(0-0) vs 0(0-0), p = 0.20; NDVH 0(0-1) vs 0(0-0.8), p < 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), p = 0.06; NDVH 0(0-3) vs 0(0-3), p < 0.001; TLH 0(0-3) vs 0(0-2), p < 0.05] at 1-year (TAH n = 47, NDVH n = 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), p = 0.08); NDVH 0(0-0) vs 0(0-0), p = 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), p = 0.33], sexual symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), p = 0.52], urinary flow symptoms [TAH 0 (0-1), NDVH 0 (0-1), TLH 0 (0-2), p = 0.56], urinary voiding symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), p = 0.64] and urinary incontinence symptoms [TAH 0 (0-0), NDVH 0 (0-1), TLH 0 (0-1), p = 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.