Mueller Margaret G, Lewicky-Gaupp Christina, Collins Sarah A, Abernethy Melinda G, Alverdy Alex, Kenton Kimberly
Division of Female Pelvic Medicine and Reconstructive Surgery, Departments of Obstetrics & Gynecology and Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois; and the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Gynecology and Obstetrics, John Hopkins University School of Medicine, Baltimore, Maryland.
Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.
To assess the relationship between prescribed postoperative activity recommendations (liberal compared with restricted) after reconstructive prolapse surgery and patient satisfaction and pelvic floor symptoms.
In our multicenter, randomized, double-blind clinical trial, women undergoing reconstructive prolapse surgery were randomized to liberal compared with restricted postoperative activity recommendations. Liberal recommendations instructed women to resume postoperative activity at the woman's own pace with no restrictions on lifting or high-impact activities. Conversely, restricted recommendations instructed women to avoid heavy lifting or strenuous exercise for 3 months. The primary outcome, patient satisfaction, was assessed on a 5-point Likert scale at 3 months postoperatively with the question, "How satisfied are you with the result of your prolapse surgery?" Secondary outcomes included anatomic outcomes and pelvic floor symptoms.
From September 2014 to December 2015, 130 women were screened and 108 were randomized. Ultimately, 95 were allocated to study intervention (n=45 liberal, n=50 restricted) and completed the primary outcome. Baseline characteristics (including pelvic organ prolapse quantification stage and demographics) and surgical intervention did not differ between groups. Most women underwent a minimally invasive sacrocolpopexy (58) followed by vaginal suspension (27) or vaginal closure procedures (nine). Rates of satisfaction were similarly high in the liberal and restricted recommendations groups (98% compared with 94%, odds ratio 0.36 [0.036-3.55], P=.619). Anatomic outcomes did not differ between groups; however, fewer pelvic floor symptoms were reported in the liberal group.
Satisfaction was equally high 3 months after prolapse surgery in women who were instructed to liberally resume activities compared with those instructed to restrict postoperative activities. Women who liberally resumed their activities reported fewer prolapse and urinary symptoms and had similar short-term anatomic outcomes suggesting that allowing women to resume their normal activities postoperatively may result in improved pelvic floor outcomes.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT02138487.
评估重建性子宫脱垂手术后规定的术后活动建议(宽松与受限相比)与患者满意度及盆底症状之间的关系。
在我们的多中心、随机、双盲临床试验中,接受重建性子宫脱垂手术的女性被随机分为术后活动建议宽松组和受限组。宽松建议指导女性按照自己的节奏恢复术后活动,对提重物或高强度活动没有限制。相反,受限建议指导女性3个月内避免提重物或剧烈运动。主要结局指标,即患者满意度,在术后3个月通过询问“您对子宫脱垂手术的结果有多满意?”以5分李克特量表进行评估。次要结局指标包括解剖学结局和盆底症状。
2014年9月至2015年12月,筛查了130名女性,108名被随机分组。最终,95名被分配到研究干预组(n = 45宽松组,n = 50受限组)并完成了主要结局指标评估。两组之间的基线特征(包括盆腔器官脱垂量化分期和人口统计学特征)以及手术干预无差异。大多数女性接受了微创骶骨阴道固定术(58例),其次是阴道悬吊术(27例)或阴道闭合手术(9例)。宽松建议组和受限建议组的满意度相似(98% 对比94%,优势比0.36 [0.036 - 3.55],P = 0.619)。两组之间的解剖学结局无差异;然而,宽松组报告的盆底症状较少。
与被指导限制术后活动的女性相比,被指导宽松恢复活动的女性在子宫脱垂手术后3个月时满意度同样高。宽松恢复活动的女性报告的脱垂和泌尿系统症状较少,且短期解剖学结局相似,这表明允许女性术后恢复正常活动可能会改善盆底结局。
ClinicalTrials.gov,www.clinicaltrials.gov,NCT02138487