Department of Woman and Child Health, Fondazione "Policlinico Universitario A. Gemelli," Rome, Italy; Department of Obstetrics and Gynecology, University of Insubria, Del Ponte Hospital, Varese, Italy.
Endoscopica Malzoni-Center for Advanced Endoscopic Gynecological Surgery, Avellino, Italy.
Am J Obstet Gynecol. 2018 May;218(5):500.e1-500.e13. doi: 10.1016/j.ajog.2018.01.029. Epub 2018 Feb 2.
Vaginal cuff dehiscence following hysterectomy is considered an infrequent but potentially devastating complication. Different possible techniques for cuff closure have been proposed to reduce this threatening adverse event.
The aim of the present randomized study was to compare laparoscopic and transvaginal suture of the vaginal vault at the end of a total laparoscopic hysterectomy, in terms of incidence of vaginal dehiscence and vaginal cuff complications. Factors associated with vaginal dehiscence were also analyzed. This article presents the results of the interim analysis of the trial.
Patients undergoing total laparoscopic hysterectomy for benign indications were randomized at the time of colpotomy to receive vaginal closure through transvaginal vs laparoscopic approach using a 1:1 ratio. Allocation concealment was obtained using a password-protected randomization database. Monopolar energy for colpotomy was set at 60W. Vaginal closure was performed with a single-layer running braided and coated 0-polyglactin suture. In all cases an attempt was performed to include the posterior peritoneum in the suture. Laparoscopic knots were tied intracorporeally. All patients were scheduled for a postoperative follow-up visit 3 months after surgery, to detect possible vaginal cuff complications. Univariate and multivariable analyses were performed to identify independent predictors of vaginal cuff dehiscence after total laparoscopic hysterectomy.
After enrollment of 1408 patients, a prespecified interim analysis was conducted. Thirteen (0.9%) women did not undergo the postoperative assessment and were excluded. Baseline characteristics of the 1395 patients included (695 in the transvaginal group and 700 in the laparoscopic group) were similar between groups. Patients in the transvaginal group had a significantly higher incidence of vaginal dehiscence (2.7% vs 1%; odds ratio, 2.78; 95% confidence interval, 1.16-6.63; P = .01) and of any cuff complication (9.8% vs 4.7%; odds ratio, 2.19; 95% confidence interval, 1.43-3.37; P = .0003). Based on these findings, the data monitoring committee recommended that the trial be terminated early. After multivariable analysis, transvaginal closure of the vault was independently associated with a higher incidence of vaginal dehiscence and any vaginal complication; premenopausal status and smoking habit were independently associated with a higher risk of dehiscence.
Laparoscopic closure of the vaginal cuff at the end of total laparoscopic hysterectomy is associated with a significant reduction of vaginal dehiscence, any cuff complication, vaginal bleeding, vaginal cuff hematoma, postoperative infection, need for vaginal resuture, and reintervention.
子宫切除术后阴道残端裂开被认为是一种罕见但潜在破坏性的并发症。已经提出了不同的阴道残端关闭技术，以减少这种威胁性的不良事件。
本随机研究的目的是比较腹腔镜和经阴道缝合阴道穹窿在全腹腔镜子宫切除术后的效果，主要比较阴道残端裂开和阴道残端并发症的发生率。同时还分析了与阴道残端裂开相关的因素。这篇文章介绍了该试验的中期分析结果。
因良性疾病行全腹腔镜子宫切除术的患者在阴道切开时随机分为经阴道组和腹腔镜组，比例为 1:1。采用密码保护的随机数据库进行分配隐藏。阴道切开时采用的电切功率为 60W。阴道缝合采用单股可吸收缝线（聚乳酸 0 号线）行连续锁边缝合。所有患者均尝试将后腹膜纳入缝合中。腹腔镜下打结在体内完成。所有患者均计划在术后 3 个月进行随访，以发现可能的阴道残端并发症。采用单变量和多变量分析确定全腹腔镜子宫切除术后阴道残端裂开的独立预测因素。
在纳入 1408 例患者后，进行了预设的中期分析。13 例（0.9%）患者未进行术后评估，被排除在外。1395 例患者的基线特征（695 例经阴道组和 700 例腹腔镜组）在组间相似。经阴道组阴道残端裂开的发生率显著高于腹腔镜组（2.7%比 1%；比值比，2.78；95%置信区间，1.16-6.63；P=0.01），任何阴道残端并发症的发生率也显著高于腹腔镜组（9.8%比 4.7%；比值比，2.19；95%置信区间，1.43-3.37；P=0.0003）。基于这些发现，数据监测委员会建议提前终止试验。多变量分析后，阴道穹窿经阴道缝合与阴道残端裂开和任何阴道并发症的发生率增加独立相关；绝经前状态和吸烟习惯与裂开风险增加独立相关。
全腹腔镜子宫切除术后腹腔镜阴道残端缝合与阴道残端裂开、任何阴道残端并发症、阴道出血、阴道残端血肿、术后感染、阴道再缝合和再次干预的需要显著减少相关。
