Perioperative interventions in pelvic organ prolapse surgery.

IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Usama Shahid, Nir Haya, Kaven Baessler, Corina Christmann-Schmid, Ellen Yeung, Zhuoran Chen, Christopher Maher
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The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse.</p><p><strong>Objectives: </strong>To compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for POP.</p><p><strong>Search methods: </strong>We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from CENTRAL, MEDLINE, two major international clinical trials registers, and handsearching of journals and conference proceedings (searched 30 April 2024). We also contacted researchers in the field.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic POP that compared a perioperative intervention related to POP surgery versus no treatment or another intervention.</p><p><strong>Data collection and analysis: </strong>We used standard methodological procedures recommended by Cochrane. Our primary outcomes were awareness of prolapse, repeat surgery for prolapse and objective failure at any site. We also measured adverse events and patient-reported outcomes. We used the GRADE approach to assess the certainty of the evidence.</p><p><strong>Main results: </strong>This review includes 49 RCTs that compared 19 different intervention groups versus a control. The trials were conducted in 15 countries, and involved 5657 women. The certainty of the evidence ranged from low to moderate. Most interventions could not be blinded, thus introducing a risk of bias. POP surgery with or without pelvic floor muscle training (PFMT): seven RCTs with 1032 women There may be no clinically relevant difference in awareness of prolapse following POP surgery with or without PFMT (odds ratio (OR) 1.07, 95% confidence interval (CI) 0.61 to 1.87; 1 study, 305 women; low-certainty evidence). This suggests that if 20% of women are aware of prolapse after surgery without PFMT, 13% to 31% are likely to be aware after POP surgery with PFMT. Similarly, there may be no clinically relevant difference in repeat surgery for prolapse with or without PFMT (OR 0.86, 95% CI 0.23 to 3.26; 1 study, 316 women; low-certainty evidence). Additionally, there may be no clinically relevant difference in objective failure at any site with or without PFMT (OR 1.24, 95% CI 0.67 to 2.29; P = 0.49; 1 study, 307 women; low-certainty evidence). Finally, there may be no clinically relevant difference in patient-reported outcomes measures with or without PFMT, including Pelvic Floor Distress Inventory-20 (PFDI-20) scores (mean difference (MD) -4.11, 95% CI -8.97 to 0.76; I² = 0%; 3 studies, 512 women; low-certainty evidence), Urinary Distress Inventory (UDI) (MD -0.23, 95% CI -4.59 to 4.14; I² = 81%, 3 studies, 289 women; low-certainty evidence), Pelvic Organ Prolapse - Distress Inventory (POP-DI) (MD 0.00, 95% CI -1.22 to 1.22; I² = 0%; 2 studies, 143 women; low-certainty evidence) and Colorectal Anal Distress Inventory (CRADI) (MD -1.70, 95% CI -7.91 to 4.51; I² = 96%; 3 studies, 291 women; low-certainty evidence). POP surgery with in-dwelling catheter (IDC) removal before 24 hours versus at 24 hours postoperatively: five RCTs with 478 women There was probably no clinically relevant difference in urinary tract infections (UTIs) between women with IDC removal before 24 hours versus at 24 hours postoperatively (OR 0.63, 95% CI 0.37 to 1.08; I² = 61%; 4 studies, 381 women; moderate-certainty evidence). Similarly, there may be no clinically relevant difference in the number of women discharged with a catheter between the two groups (OR 0.80, 95% CI 0.22 to 2.95; 1 study, 64 women; low-certainty evidence). Furthermore, there may be no clinically relevant difference in the length of stay (days) between women with IDC removal before 24 hours versus at 24 hours postoperatively (MD 0.00, 95% CI -0.10 to 0.11; I² = 45%; 3 studies, 181 women; low-certainty evidence). Finally, there may be little to no difference in total catheter days between the two groups (MD 0.10, 95% CI -0.64 to 0.84; 2 studies, 124 women; low-certainty evidence). POP surgery with IDC removal day at more than 24 hours postoperatively versus at 24 hours: two RCTs with 277 women Women may be more likely to have a large increase in UTI risk if they had an IDC for longer than one day (OR 9.25, 95% CI 3.60 to 23.75; I² = 0%; 2 studies, 274 women; low-certainty evidence). This suggests that if 4% of women get a UTI with IDC removal at 24 hours, 12% to 47% will get a UTI with IDC removal at more than 24 hours following POP surgery. Similarly, having an IDC for longer than 24 hours probably increases the length of hospital stay (MD 1.18, 95% CI 0.92 to 1.44; 2 studies, 274 women; moderate-certainty evidence). Finally, having an IDC for longer than 24 hours may result in a large increase in total catheter days (MD 2.45, 95% CI 2.14 to 2.76; 1 study, 197 women; low-certainty evidence). There were no clinically relevant differences between study groups in the few available results for the following interventions at the time of POP surgery: with or without bowel preparation, short-acting versus long-acting bupivacaine, with or without vasoconstrictors, with chlorhexadine 2% vaginal preparation versus other vaginal antiseptic solutions, with or without vaginal packing, with restricted versus liberal postoperative activity instructions, with or without vaginal oestrogen, and with or without cranberry supplementation.</p><p><strong>Authors' conclusions: </strong>There remains a paucity of data on perioperative interventions in POP surgery. We were unable to establish a clinically meaningful reduction in adverse events or increase in patient satisfaction across most of the perioperative interventions. Women may be more likely to have a large increase in UTI risk if they have an IDC for longer than one day.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"7 ","pages":"CD013105"},"PeriodicalIF":8.8000,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12281624/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cochrane Database of Systematic Reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/14651858.CD013105.pub2","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Pelvic organ prolapse (POP) is a common condition, with a significant proportion of women requiring surgical treatment. While the evidence supporting the surgical management of pelvic organ prolapse is well established, the evidence for perioperative interventions remains porous. The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse.

Objectives: To compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for POP.

Search methods: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from CENTRAL, MEDLINE, two major international clinical trials registers, and handsearching of journals and conference proceedings (searched 30 April 2024). We also contacted researchers in the field.

Selection criteria: We included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic POP that compared a perioperative intervention related to POP surgery versus no treatment or another intervention.

Data collection and analysis: We used standard methodological procedures recommended by Cochrane. Our primary outcomes were awareness of prolapse, repeat surgery for prolapse and objective failure at any site. We also measured adverse events and patient-reported outcomes. We used the GRADE approach to assess the certainty of the evidence.

Main results: This review includes 49 RCTs that compared 19 different intervention groups versus a control. The trials were conducted in 15 countries, and involved 5657 women. The certainty of the evidence ranged from low to moderate. Most interventions could not be blinded, thus introducing a risk of bias. POP surgery with or without pelvic floor muscle training (PFMT): seven RCTs with 1032 women There may be no clinically relevant difference in awareness of prolapse following POP surgery with or without PFMT (odds ratio (OR) 1.07, 95% confidence interval (CI) 0.61 to 1.87; 1 study, 305 women; low-certainty evidence). This suggests that if 20% of women are aware of prolapse after surgery without PFMT, 13% to 31% are likely to be aware after POP surgery with PFMT. Similarly, there may be no clinically relevant difference in repeat surgery for prolapse with or without PFMT (OR 0.86, 95% CI 0.23 to 3.26; 1 study, 316 women; low-certainty evidence). Additionally, there may be no clinically relevant difference in objective failure at any site with or without PFMT (OR 1.24, 95% CI 0.67 to 2.29; P = 0.49; 1 study, 307 women; low-certainty evidence). Finally, there may be no clinically relevant difference in patient-reported outcomes measures with or without PFMT, including Pelvic Floor Distress Inventory-20 (PFDI-20) scores (mean difference (MD) -4.11, 95% CI -8.97 to 0.76; I² = 0%; 3 studies, 512 women; low-certainty evidence), Urinary Distress Inventory (UDI) (MD -0.23, 95% CI -4.59 to 4.14; I² = 81%, 3 studies, 289 women; low-certainty evidence), Pelvic Organ Prolapse - Distress Inventory (POP-DI) (MD 0.00, 95% CI -1.22 to 1.22; I² = 0%; 2 studies, 143 women; low-certainty evidence) and Colorectal Anal Distress Inventory (CRADI) (MD -1.70, 95% CI -7.91 to 4.51; I² = 96%; 3 studies, 291 women; low-certainty evidence). POP surgery with in-dwelling catheter (IDC) removal before 24 hours versus at 24 hours postoperatively: five RCTs with 478 women There was probably no clinically relevant difference in urinary tract infections (UTIs) between women with IDC removal before 24 hours versus at 24 hours postoperatively (OR 0.63, 95% CI 0.37 to 1.08; I² = 61%; 4 studies, 381 women; moderate-certainty evidence). Similarly, there may be no clinically relevant difference in the number of women discharged with a catheter between the two groups (OR 0.80, 95% CI 0.22 to 2.95; 1 study, 64 women; low-certainty evidence). Furthermore, there may be no clinically relevant difference in the length of stay (days) between women with IDC removal before 24 hours versus at 24 hours postoperatively (MD 0.00, 95% CI -0.10 to 0.11; I² = 45%; 3 studies, 181 women; low-certainty evidence). Finally, there may be little to no difference in total catheter days between the two groups (MD 0.10, 95% CI -0.64 to 0.84; 2 studies, 124 women; low-certainty evidence). POP surgery with IDC removal day at more than 24 hours postoperatively versus at 24 hours: two RCTs with 277 women Women may be more likely to have a large increase in UTI risk if they had an IDC for longer than one day (OR 9.25, 95% CI 3.60 to 23.75; I² = 0%; 2 studies, 274 women; low-certainty evidence). This suggests that if 4% of women get a UTI with IDC removal at 24 hours, 12% to 47% will get a UTI with IDC removal at more than 24 hours following POP surgery. Similarly, having an IDC for longer than 24 hours probably increases the length of hospital stay (MD 1.18, 95% CI 0.92 to 1.44; 2 studies, 274 women; moderate-certainty evidence). Finally, having an IDC for longer than 24 hours may result in a large increase in total catheter days (MD 2.45, 95% CI 2.14 to 2.76; 1 study, 197 women; low-certainty evidence). There were no clinically relevant differences between study groups in the few available results for the following interventions at the time of POP surgery: with or without bowel preparation, short-acting versus long-acting bupivacaine, with or without vasoconstrictors, with chlorhexadine 2% vaginal preparation versus other vaginal antiseptic solutions, with or without vaginal packing, with restricted versus liberal postoperative activity instructions, with or without vaginal oestrogen, and with or without cranberry supplementation.

Authors' conclusions: There remains a paucity of data on perioperative interventions in POP surgery. We were unable to establish a clinically meaningful reduction in adverse events or increase in patient satisfaction across most of the perioperative interventions. Women may be more likely to have a large increase in UTI risk if they have an IDC for longer than one day.

盆腔器官脱垂手术的围手术期干预。
背景:盆腔器官脱垂(POP)是一种常见的疾病,有相当比例的女性需要手术治疗。虽然支持盆腔器官脱垂的手术治疗的证据已经得到了很好的确立,但围手术期干预的证据仍然很不充分。围手术期干预的主要目的是降低不良事件发生率,同时改善脱垂手术后妇女的预后。目的:比较围手术期一系列干预与其他干预或不干预(对照组)在POP手术时的安全性和有效性。检索方法:我们检索了Cochrane失禁组专业注册库,其中包含来自CENTRAL、MEDLINE、两个主要国际临床试验注册库的试验,以及手工检索的期刊和会议论文集(检索时间为2024年4月30日)。我们还联系了该领域的研究人员。选择标准:我们纳入了接受有症状的POP手术治疗的女性的随机对照试验(rct),比较了POP手术相关的围手术期干预与不治疗或其他干预。资料收集和分析:我们使用Cochrane推荐的标准方法程序。我们的主要结果是对脱垂的认识,脱垂的重复手术和任何部位的客观失败。我们还测量了不良事件和患者报告的结果。我们使用GRADE方法来评估证据的确定性。主要结果:本综述包括49项随机对照试验,将19个不同的干预组与对照组进行了比较。这些试验在15个国家进行,涉及5657名妇女。证据的确定性从低到中等不等。大多数干预措施不能采用盲法,因此存在偏倚风险。有或没有盆底肌训练(PFMT)的POP手术:7项随机对照试验,共1032名女性。有或没有PFMT的POP手术对脱垂的认识可能没有临床相关差异(优势比(or) 1.07, 95%可信区间(CI) 0.61 ~ 1.87;1项研究,305名女性;确定性的证据)。这表明,如果20%的女性在没有PFMT的手术后意识到脱垂,13%到31%的女性在有PFMT的POP手术后可能意识到脱垂。同样,有或没有PFMT的脱垂重复手术可能没有临床相关差异(or 0.86, 95% CI 0.23至3.26;1项研究,316名女性;确定性的证据)。此外,使用或不使用PFMT的任何部位的客观失败可能没有临床相关差异(or 1.24, 95% CI 0.67至2.29;P = 0.49;1项研究,307名女性;确定性的证据)。最后,有或没有PFMT的患者报告的结果测量可能没有临床相关的差异,包括盆底窘迫量表-20 (PFDI-20)评分(平均差异(MD) -4.11, 95% CI -8.97至0.76;I²= 0%;3项研究,512名女性;低确定性证据),尿窘迫量表(UDI) (MD -0.23, 95% CI -4.59 ~ 4.14;I²= 81%,3项研究,289名女性;低确定性证据),盆腔器官脱垂窘迫量表(POP-DI) (MD 0.00, 95% CI -1.22 ~ 1.22;I²= 0%;2项研究,143名女性;低确定性证据)和结肠直肠肛管窘迫量表(cridi) (MD -1.70, 95% CI -7.91至4.51;I²= 96%;3项研究,291名女性;确定性的证据)。24小时前取出留置导尿管(IDC)与术后24小时:5项随机对照试验,共478名女性。24小时前取出导尿管与术后24小时取出导尿管的女性尿路感染(uti)可能没有临床相关差异(OR 0.63, 95% CI 0.37 ~ 1.08;I²= 61%;4项研究,381名女性;moderate-certainty证据)。同样,两组间留置导管出院的妇女人数可能没有临床相关差异(OR 0.80, 95% CI 0.22 ~ 2.95;1项研究,64名女性;确定性的证据)。此外,24小时前与术后24小时切除IDC的女性在住院时间(天)上可能没有临床相关差异(MD 0.00, 95% CI -0.10 ~ 0.11;I²= 45%;3项研究,181名女性;确定性的证据)。最后,两组之间的总导管天数可能几乎没有差异(MD 0.10, 95% CI -0.64至0.84;2项研究,124名女性;确定性的证据)。POP手术术后24小时与24小时取出IDC相比:两项随机对照试验纳入277名女性,如果取出IDC超过一天,女性的UTI风险可能会大幅增加(OR 9.25, 95% CI 3.60至23.75;I²= 0%;2项研究,274名女性;确定性的证据)。这表明,如果4%的女性在24小时内出现尿路感染并取出IDC,那么在POP手术后超过24小时,12%至47%的女性会出现尿路感染并取出IDC。同样,IDC超过24小时可能会增加住院时间(MD 1.18, 95% CI 0。 92比1.44;2项研究,274名女性;moderate-certainty证据)。最后,IDC超过24小时可能导致导管总天数的大量增加(MD 2.45, 95% CI 2.14 ~ 2.76;1项研究,197名女性;确定性的证据)。在POP手术时,以下干预措施的少数可用结果在研究组之间没有临床相关差异:有或没有肠道准备,短效布比卡因与长效布比卡因,有或没有血管收缩剂,氯己定2%阴道准备与其他阴道消毒溶液,有或没有阴道填充物,有或没有阴道雌激素,有或没有阴道雌激素,有或没有蔓越莓补充剂。作者的结论是:关于POP手术围手术期干预的数据仍然缺乏。在大多数围手术期干预措施中,我们无法确定有临床意义的不良事件减少或患者满意度的提高。如果女性的IDC持续时间超过一天,她们患UTI的风险可能会大幅增加。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
10.60
自引率
2.40%
发文量
173
审稿时长
1-2 weeks
期刊介绍: The Cochrane Database of Systematic Reviews (CDSR) stands as the premier database for systematic reviews in healthcare. It comprises Cochrane Reviews, along with protocols for these reviews, editorials, and supplements. Owned and operated by Cochrane, a worldwide independent network of healthcare stakeholders, the CDSR (ISSN 1469-493X) encompasses a broad spectrum of health-related topics, including health services.
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