Department of Obstetrics & Gynecology, Kaiser Permanente, San Diego, San Diego, CA; Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California San Diego Health, San Diego, CA.
Department of Obstetrics & Gynecology, Penn Medicine, Princeton, NJ.
Am J Obstet Gynecol. 2022 Aug;227(2):306.e1-306.e16. doi: 10.1016/j.ajog.2022.05.046. Epub 2022 May 30.
Although several different apical suspension procedures are available to women with pelvic organ prolapse, data on long-term efficacy and safety profiles are limited.
The primary aim of this study was to analyze longitudinal reoperation risk for recurrent prolapse among the 4 apical suspension procedures over 2 to 15 years. Secondary aims included evaluation of all-cause reoperation, defined as a repeated surgery for the indications of recurrent prolapse and adverse events, and total retreatment rate, which included a repeated treatment with another surgery or a pessary.
This was a multicenter, retrospective cohort study within Kaiser Permanente Southern California that included women who underwent sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament fixation, or colpocleisis from January 2006 through December 2018. Women who underwent concomitant rectal prolapse repair or vaginal prolapse repair with mesh augmentation were excluded. Data were abstracted using procedural and diagnostic codes through July 2021, with manual review of 10% of each variable. Patient demographics and pessary use were compared using analysis of variance or chi square tests for continuous and categorical variables, respectively. Time-to-event analysis was used to contrast reoperation rates. A Cox regression model was used to perform an adjusted multivariate analysis of the following predictors of reoperation for recurrence: index surgery, concomitant procedures, patient demographics, baseline comorbidities, and year of index surgery. Censoring events included exit from the health maintenance organization and death.
The cohort included 9681 women with maximum follow-up of 14.8 years. The overall incidence of reoperation for recurrent prolapse was 7.4 reoperations per 1000 patient-years, which differed significantly by type of apical suspension (P<.0001). The incidence of reoperation was lower after colpocleisis (1.4 events per 1000 patient-years) and sacrocolpopexy (4.8 events per 1000 patient-years) when compared with uterosacral ligament suspension (9 events per 1000 patient-years) and sacrospinous ligament fixation (13.9 events per 1000 patient-years). All pairwise comparisons between procedures were significant (P=.0003-.0018) after correction for multiplicity, except for uterosacral ligament suspension or uterosacral ligament hysteropexy vs sacrospinous ligament fixation or sacrospinous ligament hysteropexy (P=.05). The index procedure was the only significant predictor of reoperation for recurrence (P=.0003-.0024) on multivariate regression analysis. Reoperations for complications or sequelae (overall 2.9 events per 1000 patient-years) also differed by index procedure (P<.0001) and were highest after sacrocolpopexy (4.4 events per 1000 patient-years). The incidence of all-cause reoperation for recurrence and adverse events after sacrocolpopexy, however, was comparable to that of the other reconstructive procedures (P=.1-.4) in pairwise comparisons with Bonferroni correction. Similarly, frequency of pessary use differed by index procedure (P<.0001) and was highest after sacrospinous ligament fixation at 9.3% (43/464).
Among nearly 10,000 patients undergoing prolapse surgery within a large managed care organization, colpocleisis and sacrocolpopexy offered the most durable obliterative and reconstructive prolapse repairs, respectively. All-cause reoperation rates were lowest after colpocleisis by a large margin, but similar among reconstructive apical suspension procedures.
尽管有几种不同的阴道顶端悬吊术可用于治疗盆腔器官脱垂的女性，但关于长期疗效和安全性的资料有限。
本研究的主要目的是分析 4 种阴道顶端悬吊术在 2 至 15 年内再次发生脱垂的纵向再手术风险。次要目的包括评估所有原因的再手术，定义为因复发脱垂和不良事件而再次进行的手术，以及总再治疗率，包括再次使用手术或阴道托进行的治疗。
这是一项在 Kaiser Permanente Southern California 进行的多中心回顾性队列研究，纳入了 2006 年 1 月至 2018 年 12 月期间接受骶骨阴道固定术、子宫骶骨韧带悬吊术、骶棘韧带固定术或阴道封闭术的女性。排除同时行直肠脱垂修复或阴道脱垂修复伴网片增强的女性。数据通过 2021 年 7 月使用程序和诊断代码进行提取，并对每个变量的 10%进行手动审查。使用方差分析或卡方检验分别比较患者的人口统计学特征和阴道托的使用情况，用于连续和分类变量。使用时间事件分析对比再手术率。使用 Cox 回归模型对以下预测复发再手术的因素进行多变量调整分析：索引手术、伴随手术、患者人口统计学特征、基线合并症和索引手术年份。截尾事件包括退出医疗保健组织和死亡。
队列纳入了 9681 名女性，最大随访时间为 14.8 年。复发脱垂的总再手术发生率为每 1000 名患者 7.4 例，不同阴道顶端悬吊术之间差异显著（P<.0001）。与子宫骶骨韧带悬吊术（每 1000 名患者 9 例）和骶棘韧带固定术（每 1000 名患者 13.9 例）相比，阴道封闭术（每 1000 名患者 1.4 例）和骶骨阴道固定术（每 1000 名患者 4.8 例）的再手术发生率较低。在进行多重校正后，除了子宫骶骨韧带悬吊术或子宫骶骨韧带固定术与骶棘韧带固定术或骶棘韧带固定术之间（P=.05），所有手术之间的比较均具有统计学意义（P=.0003-.0018）。多变量回归分析显示，索引手术是再手术的唯一显著预测因素（P=.0003-.0024）。因并发症或后遗症的再手术（每 1000 名患者 2.9 例）也因索引手术而异（P<.0001），在骶骨阴道固定术后发生率最高（每 1000 名患者 4.4 例）。然而，在与 Bonferroni 校正的配对比较中，与其他重建性手术相比，骶骨阴道固定术和骶骨阴道固定术的所有原因再手术率（P=.1-.4）和因复发脱垂和不良事件的再手术率（P<.0001）相似。同样，索引手术也会影响阴道托的使用频率（P<.0001），骶棘韧带固定术后的使用频率最高，为 9.3%（43/464）。
在一个大型管理式医疗组织中，近 10000 名接受脱垂手术的患者中，阴道封闭术和骶骨阴道固定术分别为最持久的闭塞性和重建性脱垂修复术。阴道封闭术的所有原因再手术率最低，但与重建性阴道顶端悬吊术相似。
