Ahmad Gaity, Thompson Matthew, Kim Kyungmin, Agarwal Priya, Mackie Fiona L, Dias Sofia, Metwally Mostafa, Watson Andrew
Department of Obstetrics and Gynaecology, Pennine Acute Hospitals NHS Trust, Manchester, UK.
Pennine Acute Hospitals NHS Trust, Manchester, UK.
Cochrane Database Syst Rev. 2020 Jul 17;7(7):CD001298. doi: 10.1002/14651858.CD001298.pub5.
Adhesions are fibrin bands that are a common consequence of gynaecological surgery. They are caused by conditions that include pelvic inflammatory disease and endometriosis. Adhesions are associated with comorbidities, including pelvic pain, subfertility, and small bowel obstruction. Adhesions also increase the likelihood of further surgery, causing distress and unnecessary expenses. Strategies to prevent adhesion formation include the use of fluid (also called hydroflotation) and gel agents, which aim to prevent healing tissues from touching one another, or drugs, aimed to change an aspect of the healing process, to make adhesions less likely to form.
To evaluate the effectiveness and safety of fluid and pharmacological agents on rates of pain, live births, and adhesion prevention in women undergoing gynaecological surgery.
We searched: the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and Epistemonikos to 22 August 2019. We also checked the reference lists of relevant papers and contacted experts in the field.
Randomised controlled trials investigating the use of fluid (including gel) and pharmacological agents to prevent adhesions after gynaecological surgery.
We used standard methodological procedures recommended by Cochrane. We assessed the overall quality of the evidence using GRADE methods. Outcomes of interest were pelvic pain; live birth rates; incidence of, mean, and changes in adhesion scores at second look-laparoscopy (SLL); clinical pregnancy, miscarriage, and ectopic pregnancy rates; quality of life at SLL; and adverse events.
We included 32 trials (3492 women), and excluded 11. We were unable to include data from nine studies in the statistical analyses, but the findings of these studies were broadly in keeping with the findings of the meta-analyses. Hydroflotation agents versus no hydroflotation agents (10 RCTs) We are uncertain whether hydroflotation agents affected pelvic pain (odds ratio (OR) 1.05, 95% confidence interval (CI) 0.52 to 2.09; one study, 226 women; very low-quality evidence). It is unclear whether hydroflotation agents affected live birth rates (OR 0.67, 95% CI 0.29 to 1.58; two studies, 208 women; low-quality evidence) compared with no treatment. Hydroflotation agents reduced the incidence of adhesions at SLL when compared with no treatment (OR 0.34, 95% CI 0.22 to 0.55, four studies, 566 women; high-quality evidence). The evidence suggests that in women with an 84% chance of having adhesions at SLL with no treatment, using hydroflotation agents would result in 54% to 75% having adhesions. Hydroflotation agents probably made little or no difference to mean adhesion score at SLL (standardised mean difference (SMD) -0.06, 95% CI -0.20 to 0.09; four studies, 722 women; moderate-quality evidence). It is unclear whether hydroflotation agents affected clinical pregnancy rate (OR 0.64, 95% CI 0.36 to 1.14; three studies, 310 women; moderate-quality evidence) compared with no treatment. This suggests that in women with a 26% chance of clinical pregnancy with no treatment, using hydroflotation agents would result in a clinical pregnancy rate of 11% to 28%. No studies reported any adverse events attributable to the intervention. Gel agents versus no treatment (12 RCTs) No studies in this comparison reported pelvic pain or live birth rate. Gel agents reduced the incidence of adhesions at SLL compared with no treatment (OR 0.26, 95% CI 0.12 to 0.57; five studies, 147 women; high-quality evidence). This suggests that in women with an 84% chance of having adhesions at SLL with no treatment, the use of gel agents would result in 39% to 75% having adhesions. It is unclear whether gel agents affected mean adhesion scores at SLL (SMD -0.50, 95% CI -1.09 to 0.09; four studies, 159 women; moderate-quality evidence), or clinical pregnancy rate (OR 0.20, 95% CI 0.02 to 2.02; one study, 30 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Gel agents versus hydroflotation agents when used as an instillant (3 RCTs) No studies in this comparison reported pelvic pain, live birth rate or clinical pregnancy rate. Gel agents probably reduce the incidence of adhesions at SLL when compared with hydroflotation agents (OR 0.50, 95% CI 0.31 to 0.83; three studies, 538 women; moderate-quality evidence). This suggests that in women with a 46% chance of having adhesions at SLL with a hydroflotation agent, the use of gel agents would result in 21% to 41% having adhesions. We are uncertain whether gel agents improved mean adhesion scores at SLL when compared with hydroflotation agents (MD -0.79, 95% CI -0.82 to -0.76; one study, 77 women; very low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Steroids (any route) versus no steroids (4 RCTs) No studies in this comparison reported pelvic pain, incidence of adhesions at SLL or mean adhesion score at SLL. It is unclear whether steroids affected live birth rates compared with no steroids (OR 0.65, 95% CI 0.26 to 1.62; two studies, 223 women; low-quality evidence), or clinical pregnancy rates (OR 1.01, 95% CI 0.66 to 1.55; three studies, 410 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention.
AUTHORS' CONCLUSIONS: Gels and hydroflotation agents appear to be effective adhesion prevention agents for use during gynaecological surgery, but we found no evidence indicating that they improve fertility outcomes or pelvic pain, and further research is required in this area. It is also worth noting that for some comparisons, wide confidence intervals crossing the line of no effect meant that clinical harm as a result of interventions could not be excluded. Future studies should measure outcomes in a uniform manner, using the modified American Fertility Society score. Statistical findings should be reported in full. No studies reported any adverse events attributable to intervention.
粘连是纤维蛋白带,是妇科手术常见的后果。它们由包括盆腔炎和子宫内膜异位症在内的病症引起。粘连与多种合并症相关,包括盆腔疼痛、生育力低下和小肠梗阻。粘连还会增加进一步手术的可能性,造成痛苦和不必要的费用。预防粘连形成的策略包括使用液体(也称为水浮法)和凝胶剂,其目的是防止愈合组织相互接触,或使用药物,旨在改变愈合过程的某个方面,使粘连形成的可能性降低。
评估液体和药物制剂对接受妇科手术的女性的疼痛发生率、活产率和粘连预防效果的有效性和安全性。
我们检索了截至2019年8月22日的Cochrane妇科和生育专业注册库、CENTRAL、MEDLINE、Embase、PsycINFO和Epistemonikos。我们还检查了相关论文的参考文献列表并联系了该领域的专家。
调查使用液体(包括凝胶)和药物制剂预防妇科手术后粘连的随机对照试验。
我们采用Cochrane推荐的标准方法程序。我们使用GRADE方法评估证据的总体质量。感兴趣的结果包括盆腔疼痛;活产率;二次腹腔镜检查(SLL)时粘连评分的发生率、平均值和变化;临床妊娠、流产和异位妊娠率;SLL时的生活质量;以及不良事件。
我们纳入了32项试验(3492名女性),并排除了11项。我们无法将9项研究的数据纳入统计分析,但这些研究的结果与荟萃分析的结果大致一致。水浮法制剂与非水浮法制剂(10项随机对照试验)我们不确定水浮法制剂是否会影响盆腔疼痛(优势比(OR)1.05,95%置信区间(CI)0.52至2.09;一项研究,226名女性;极低质量证据)。与未治疗相比,尚不清楚水浮法制剂是否会影响活产率(OR 0.67,95%CI 0.29至1.58;两项研究,208名女性;低质量证据)。与未治疗相比,水浮法制剂降低了SLL时粘连的发生率(OR 0.34,95%CI 0.22至0.55,四项研究,566名女性;高质量证据)。证据表明,在未治疗的情况下SLL时有粘连可能性为84%的女性中,使用水浮法制剂将导致粘连发生率为54%至75%。水浮法制剂可能对SLL时的平均粘连评分影响很小或没有影响(标准化平均差(SMD)-0.06,95%CI -0.20至0.09;四项研究,722名女性;中等质量证据)。与未治疗相比,尚不清楚水浮法制剂是否会影响临床妊娠率(OR 0.64,95%CI 0.36至1.14;三项研究,310名女性;中等质量证据)。这表明在未治疗的情况下临床妊娠可能性为26%的女性中,使用水浮法制剂将导致临床妊娠率为11%至28%。没有研究报告任何可归因于该干预措施的不良事件。凝胶剂与未治疗(12项随机对照试验)该比较中没有研究报告盆腔疼痛或活产率。与未治疗相比,凝胶剂降低了SLL时粘连的发生率(OR 0.26,95%CI 0.12至0.57;五项研究,147名女性;高质量证据)。这表明在未治疗的情况下SLL时有粘连可能性为84%的女性中,使用凝胶剂将导致粘连发生率为39%至75%。尚不清楚凝胶剂是否会影响SLL时的平均粘连评分(SMD -0.50,95%CI -1.09至0.09;四项研究,159名女性;中等质量证据),或临床妊娠率(OR 0.20,95%CI 0.02至2.02;一项研究,30名女性;低质量证据)。该比较中没有研究报告可归因于该干预措施的不良事件。作为灌注剂使用时凝胶剂与水浮法制剂(3项随机对照试验)该比较中没有研究报告盆腔疼痛、活产率或临床妊娠率。与水浮法制剂相比,凝胶剂可能会降低SLL时粘连的发生率(OR 0.50,95%CI 0.31至0.83;三项研究;538名女性;中等质量证据)。这表明在使用水浮法制剂时SLL时有粘连可能性为46%的女性中,使用凝胶剂将导致粘连发生率为21%至41%。与水浮法制剂相比,我们不确定凝胶剂是否会改善SLL时的平均粘连评分(MD -0.79,95%CI -0.82至-0.76;一项研究,77名女性;极低质量证据)。该比较中没有研究报告可归因于该干预措施的不良事件。类固醇(任何途径)与非类固醇(4项随机对照试验)该比较中没有研究报告盆腔疼痛、SLL时粘连的发生率或SLL时的平均粘连评分。与非类固醇相比,尚不清楚类固醇是否会影响活产率(OR 0.65,95%CI 0.26至1.62;两项研究,223名女性;低质量证据),或临床妊娠率(OR 1.01,95%CI 0.66至1.55;三项研究,410名女性;低质量证据)。该比较中没有研究报告可归因于该干预措施的不良事件。
凝胶剂和水浮法制剂似乎是妇科手术中有效的粘连预防剂,但我们没有发现证据表明它们能改善生育结局或盆腔疼痛,该领域需要进一步研究。还值得注意的是,对于某些比较,宽置信区间跨越无效应线意味着不能排除干预导致的临床危害。未来的研究应以统一的方式测量结局,使用改良的美国生育协会评分。应完整报告统计结果。没有研究报告任何可归因于干预的不良事件。