Shahid Usama, Haya Nir, Baessler Kaven, Christmann-Schmid Corina, Yeung Ellen, Chen Zhuoran, Maher Christopher
Royal Brisbane and Women's Hospital, James Cook University, Brisbane, Australia.
Technion Israel Institute of Technology, Rappaport Faculty of Medicine & Department of Obstetrics and Gynaecology, Rambam Health Care Campus, Haifa, Israel.
Cochrane Database Syst Rev. 2025 Jul 22;7(7):CD013105. doi: 10.1002/14651858.CD013105.pub2.
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.
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.
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.
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.
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.
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(POP)是一种常见病症,很大一部分女性需要接受手术治疗。虽然支持盆腔器官脱垂手术治疗的证据确凿,但围手术期干预措施的证据仍不充分。围手术期干预的主要目标是降低不良事件发生率,同时改善女性在脱垂手术干预后的预后。
比较一系列围手术期干预措施与其他干预措施或不进行干预(对照组)在POP手术时的安全性和有效性。
我们检索了Cochrane尿失禁小组专业注册库,其中包含从Cochrane系统评价数据库、MEDLINE、两个主要国际临床试验注册库中识别出的试验,以及对手稿和会议论文集的手工检索(检索至2024年4月30日)。我们还联系了该领域的研究人员。
我们纳入了对有症状POP接受手术治疗的女性进行的随机对照试验(RCT),这些试验比较了与POP手术相关的围手术期干预措施与不治疗或其他干预措施。
我们采用了Cochrane推荐的标准方法程序。我们的主要结局是脱垂的知晓率、脱垂的再次手术率以及任何部位的客观失败率。我们还测量了不良事件和患者报告的结局。我们采用GRADE方法评估证据的确定性。
本综述纳入了49项RCT,比较了19个不同的干预组与对照组。这些试验在15个国家进行,涉及5657名女性。证据的确定性从低到中等。大多数干预措施无法设盲,因此存在偏倚风险。
有或无盆底肌训练(PFMT)的POP手术:7项RCT,共1032名女性
有或无PFMT的POP手术后,脱垂知晓率可能无临床相关差异(优势比(OR)1.07,95%置信区间(CI)0.61至1.87;1项研究,305名女性;低确定性证据)。这表明,如果20%的女性在无PFMT的手术后知晓脱垂,那么在有PFMT的POP手术后,13%至31%的女性可能会知晓。同样,有或无PFMT的脱垂再次手术率可能无临床相关差异(OR 0.86,95%CI 0.23至3.26;1项研究,316名女性;低确定性证据)。此外,有或无PFMT的任何部位客观失败率可能无临床相关差异(OR 1.24,95%CI 0.67至2.29;P = 0.49;1项研究,307名女性;低确定性证据)。最后,有或无PFMT的患者报告结局指标可能无临床相关差异,包括盆底困扰量表-20(PFDI-20)评分(平均差(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)、尿路困扰量表(UDI)(MD -0.23,95%CI -4.59至4.14;I² = 81%,3项研究,289名女性;低确定性证据)、盆腔器官脱垂困扰量表(POP-DI)(MD 0.00,95%CI -1.22至1.22;I² = 0%;2项研究,143名女性;低确定性证据)和结直肠肛门困扰量表(CRADI)(MD -1.70,95%CI -7.91至4.51;I² = 96%;3项研究,291名女性;低确定性证据)。
术后24小时内与术后24小时拔除留置导管(IDC)的POP手术:5项RCT,共478名女性
术后24小时内拔除IDC与术后24小时拔除IDC的女性之间泌尿系统感染(UTI)可能无临床相关差异(OR 0.63,95%CI 0.37至1.08;I² = 61%;4项研究,381名女性;中等确定性证据)。同样,两组之间带导管出院的女性数量可能无临床相关差异(OR 0.80,95%CI 0.22至2.95;1项研究,64名女性;低确定性证据)。此外,术后24小时内拔除IDC与术后24小时拔除IDC的女性住院天数(天)可能无临床相关差异(MD 0.00,95%CI -0.10至0.11;I² = 45%;3项研究,181名女性;低确定性证据)。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;低确定性证据)。
术后24小时以上与术后24小时拔除IDC的POP手术:2项RCT,共277名女性
如果女性的IDC留置时间超过一天,她们发生UTI风险大幅增加的可能性可能更高(OR 9.25,95%CI 3.60至23.75;I² = 0%;2项研究,274名女性;低确定性证据)。这表明,如果4%的女性在术后24小时拔除IDC时发生UTI,那么在POP手术后IDC留置时间超过24小时时,12%至47%的女性会发生UTI。同样,IDC留置时间超过24小时可能会增加住院时间(MD 1.18,95%CI 0.92至1.44;2项研究,274名女性;中等确定性证据)。最后,IDC留置时间超过24小时可能会导致总导管天数大幅增加(MD 2.45,95%CI 2.14至2.76;1项研究,197名女性;低确定性证据)。
在POP手术时,以下干预措施的现有少数结果在研究组之间无临床相关差异:有无肠道准备、短效与长效布比卡因、有无血管收缩剂使用、2%氯己定阴道制剂与其他阴道防腐剂溶液、有无阴道填塞物、术后活动指导受限与宽松、有无阴道雌激素使用以及有无蔓越莓补充剂。
关于POP手术围手术期干预的数据仍然匮乏。我们无法证实大多数围手术期干预措施能在临床上显著降低不良事件发生率或提高患者满意度。如果女性的IDC留置时间超过一天,她们发生UTI风险大幅增加的可能性可能更高。