Marschalek Marie-Louise, Bodner Klaus, Kimberger Oliver, Morgenbesser Raffaela, Dietrich Wolf, Obruca Christian, Husslein Heinrich, Umek Wolfgang, Kölbl Heinz, Bodner-Adler Barbara
Department of General Gynecology and Gynecologic Oncology, Medical University Vienna, 1090 Vienna, Austria.
Department of Anesthesiology, Medical University of Vienna, 1090 Vienna, Austria.
J Clin Med. 2021 Jun 7;10(11):2531. doi: 10.3390/jcm10112531.
The aim of this prospective randomized, double-masked, placebo-controlled, multicenter study was to analyze the surgeon's individual assessment of tissue quality during pelvic floor surgery in postmenopausal women pre-treated with local estrogen therapy (LET) or placebo cream. Secondary outcomes included intraoperative and early postoperative course of the two study groups. Surgeons, blinded to patient's preoperative treatment, completed an 8-item questionnaire after each prolapse surgery to assess tissue quality as well as surgical conditions. Our hypothesis was that there is no significant difference in individual surgical assessment of tissue quality between local estrogen or placebo pre-treatment. Multivariate logistic regression analysis was performed to identify independent risk factors for intra- or early postoperative complications. Out of 120 randomized women, 103 (86%) remained for final analysis. Surgeons assessed the tissue quality similarity in cases with or without LET, representing no statistically significant differences concerning tissue perfusion, tissue atrophy, tissue consistency, difficulty of dissection and regular pelvic anatomy. Regarding pre-treatment, the rating of the surgeon correlated significantly with LET (r = 0.043), meaning a correct assumption of the surgeon. Operative time, intraoperative blood loss, occurrence of intraoperative complications, total length of stay, frequent use of analgesics and rate of readmission did not significantly differ between LET and placebo pre-treatment. The rate of defined postoperative complications and use of antibiotics was significantly more frequent in patients without LET ( = 0.045 and = 0.003). Tissue quality was similarly assessed in cases with or without local estrogen pre-treatment, but it seems that LET prior to prolapse surgery may improve vaginal health as well as tissue-healing processes, protecting these patients from early postoperative complications.
这项前瞻性随机、双盲、安慰剂对照、多中心研究的目的是分析在接受局部雌激素治疗（LET）或安慰剂乳膏预处理的绝经后女性盆底手术中，外科医生对组织质量的个体评估。次要结局包括两个研究组的术中及术后早期病程。对患者术前治疗不知情的外科医生在每次脱垂手术后完成一份8项问卷，以评估组织质量和手术情况。我们的假设是局部雌激素或安慰剂预处理在组织质量的个体手术评估中无显著差异。进行多变量逻辑回归分析以确定术中或术后早期并发症的独立危险因素。120名随机分组的女性中，103名（86%）纳入最终分析。外科医生评估了接受或未接受LET治疗病例的组织质量相似性，在组织灌注、组织萎缩、组织质地、解剖难度和正常盆腔解剖方面无统计学显著差异。关于预处理，外科医生的评分与LET显著相关（r = 0.043），这意味着外科医生的判断正确。LET和安慰剂预处理组在手术时间、术中失血、术中并发症发生率、住院总时长、频繁使用镇痛药和再入院率方面无显著差异。未接受LET治疗的患者中，明确的术后并发症发生率和抗生素使用率显著更高（P = 0.045和P = 0.003）。接受或未接受局部雌激素预处理的病例中组织质量评估相似，但脱垂手术前使用LET似乎可改善阴道健康以及组织愈合过程，使这些患者免受术后早期并发症影响。
