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根治性子宫切除术治疗早期宫颈癌后预防膀胱功能障碍的术后干预。

Postoperative interventions for preventing bladder dysfunction after radical hysterectomy in women with early-stage cervical cancer.

机构信息

Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.

Department of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, Khon Kaen, Thailand.

出版信息

Cochrane Database Syst Rev. 2021 Jan 25;1(1):CD012863. doi: 10.1002/14651858.CD012863.pub2.

Abstract

BACKGROUND

Bladder dysfunction is a common complication following radical hysterectomy, caused by the damage to pelvic autonomic nerves that innervate the muscles of the bladder, urethral sphincter, and pelvic floor fasciae. Bladder dysfunction increases the rates of urinary tract infection, hospital visits or admission, and patient dissatisfaction. In addition, bladder dysfunction can also negatively impact patient quality of life (QoL). Several postoperative interventions have been proposed to prevent bladder dysfunction following radical hysterectomy. To our knowledge, there has been no systematic review evaluating the effectiveness and safety of these interventions for preventing bladder dysfunction following radical hysterectomy in women with cervical cancer.

OBJECTIVES

To evaluate the effectiveness and safety of postoperative interventions for preventing bladder dysfunction following radical hysterectomy in women with early-stage cervical cancer (stage IA2 to IIA2).

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4) in the Cochrane Library, MEDLINE via Ovid (1946 to April week 2, 2020), and Embase via Ovid (1980 to 2020, week 16). We also checked registers of clinical trials, grey literature, conference reports, and citation lists of included studies.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) evaluating the effectiveness and safety of any type of postoperative interventions for preventing bladder dysfunction following a radical hysterectomy in women with stage IA2 to IIA2 cervical cancer.

DATA COLLECTION AND ANALYSIS

Two review authors independently selected potentially relevant RCTs, extracted data, assessed risk of bias, compared results, and made judgments on the quality and certainty of the evidence. We resolved any disagreements through discussion or consultation with a third review author. Outcomes of interest consisted of spontaneous voiding recovery one week after the operation, quality of life (QoL), adverse events, post-void residual urine volume one month after the operation, urinary tract infection over the one month following the operation, and subjective urinary symptoms.

MAIN RESULTS

We identified 1464 records as a result of the search (excluding duplicates). Of the 20 records that potentially met the review criteria, we included five reports of four studies. Most of the studies had unclear risks of selection and reporting biases. Of the four studies, one compared bethanechol versus placebo and three studies compared suprapubic catheterisation with intermittent self-catheterisation. We identified two ongoing studies. Bethanechol versus placebo The study reported no information on the rate of spontaneous voiding recovery at one week following the operation, QoL, adverse events, urinary tract infection in the first month after surgery, and subjective urinary symptoms for this comparison. The volume of post-void residual urine, assessed at one month after surgery, among women receiving bethanechol was lower than those in the placebo group (mean difference (MD) -37.4 mL, 95% confidence interval (CI) -60.35 to -14.45; one study, 39 participants; very-low certainty evidence). Suprapubic catheterisation versus intermittent self-catheterisation The studies reported no information on the rate of spontaneous voiding recovery at one week and post-void residual urine volume at one month following the operation for this comparison. There was no difference in risks of acute complication (risk ratio (RR) 0.77, 95% CI 0.24 to 2.49; one study, 71 participants; very low certainty evidence) and urinary tract infections during the first month after surgery (RR 0.77, 95% CI 0.53 to 1.13; two studies, 95 participants; very- low certainty evidence) between participants who underwent suprapubic catheterisation and those who underwent intermittent self-catheterisation. Available data were insufficient to calculate the relative measures of the effect of interventions on QoL and subjective urinary symptoms.

AUTHORS' CONCLUSIONS: None of the included studies reported rate of spontaneous voiding recovery one week after surgery, time to a post-void residual volume of urine of 50 mL or less, or post-void residual urine volume at 6 and 12 months after surgery, all of which are important outcomes for assessing postoperative bladder dysfunction. Limited evidence suggested that bethanechol may minimise the risk of bladder dysfunction after radical hysterectomy by lowering post-void residual urine volume. The certainty of this evidence, however, was very low. The effectiveness of different types of postoperative urinary catheterisation (suprapubic and intermittent self-catheterisation) remain unproven.

摘要

背景

膀胱功能障碍是根治性子宫切除术的常见并发症,由支配膀胱、尿道括约肌和盆底筋膜肌肉的盆腔自主神经损伤引起。膀胱功能障碍会增加尿路感染、住院或入院率以及患者不满的风险。此外,膀胱功能障碍还会对患者的生活质量(QoL)产生负面影响。已经提出了几种术后干预措施来预防宫颈癌根治性子宫切除术后的膀胱功能障碍。据我们所知,还没有系统评价评估这些干预措施预防宫颈癌早期(IA2 至 IIA2 期)患者根治性子宫切除术后膀胱功能障碍的有效性和安全性。

目的

评估术后干预措施预防早期宫颈癌(IA2 至 IIA2 期)患者根治性子宫切除术后膀胱功能障碍的有效性和安全性。

检索方法

我们检索了 Cochrane 图书馆中的 Cochrane 对照试验中心注册库(CENTRAL;2020 年第 4 期)、Ovid 中的 MEDLINE(1946 年至 2020 年 4 月第 2 周)和 Ovid 中的 Embase(1980 年至 2020 年第 16 周)。我们还检查了临床试验登记处、灰色文献、会议报告和纳入研究的参考文献列表。

选择标准

我们纳入了评估 IA2 至 IIA2 期宫颈癌患者根治性子宫切除术后任何类型术后干预措施预防膀胱功能障碍的有效性和安全性的随机对照试验(RCT)。

数据收集和分析

两名综述作者独立选择了可能相关的 RCT,提取数据,评估风险偏倚,比较结果,并对证据的质量和确定性做出判断。我们通过讨论或咨询第三位综述作者来解决任何分歧。我们感兴趣的结果包括术后一周自发排尿恢复、生活质量(QoL)、不良事件、术后一个月残余尿量、术后一个月尿路感染和主观尿症状。

主要结果

我们的搜索结果排除重复后确定了 1464 条记录。在 20 条可能符合审查标准的记录中,我们纳入了四项研究的四份报告。大多数研究的选择和报告偏倚风险不明确。四项研究中的一项比较了氨甲酰胆碱与安慰剂,三项研究比较了耻骨上导管与间歇性自我导尿。我们确定了两项正在进行的研究。氨甲酰胆碱与安慰剂:这项研究没有报告手术后一周内自发排尿恢复率、QoL、不良事件、手术后第一个月尿路感染和主观尿症状的信息。接受氨甲酰胆碱治疗的女性在术后一个月时的残余尿量(MD-37.4mL,95%CI-60.35 至-14.45;一项研究,39 名参与者;极低确定性证据)低于安慰剂组。耻骨上导管与间歇性自我导尿:这些研究没有报告手术后一周内自发排尿恢复率和术后一个月残余尿量的信息。接受耻骨上导管和间歇性自我导尿的患者在急性并发症风险(RR0.77,95%CI0.24 至 2.49;一项研究,71 名参与者;极低确定性证据)和手术后第一个月尿路感染(RR0.77,95%CI0.53 至 1.13;两项研究,95 名参与者;极低确定性证据)方面无差异。关于干预措施对 QoL 和主观尿症状的影响的相对措施,可用数据不足以计算。

作者结论

纳入的研究均未报告术后一周内自发排尿恢复率、残余尿量达到 50ml 或更少的时间、或术后 6 个月和 12 个月的残余尿量,这些都是评估术后膀胱功能障碍的重要指标。有限的证据表明,氨甲酰胆碱通过降低残余尿量可能会降低根治性子宫切除术后膀胱功能障碍的风险。然而,这种证据的确定性非常低。不同类型的术后导尿(耻骨上和间歇性自我导尿)的有效性仍未得到证实。

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