Evaluating a Novel Active Recovery Program in the Immediate Postoperative Period Following Pelvic Reconstructive Surgery: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)
研究概览
简要总结
This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery.
详细描述
This is a randomized controlled trial comparing usual care postoperative restrictions and a novel new active recovery program to look at differences in pelvic floor function, patient quality of life, and mental health in between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 89
- •Undergoing minimally invasive apical prolapse reconstructive procedure at OHSU. This includes laparoscopic and robotic-assisted sacrocolpopexy, laparoscopic and vaginal uterosacral ligament suspension, and vaginal sacrospinous ligament fixation. We will include patients undergoing concomitant procedures such as hysterectomy and incontinence procedures.
- •Have access to reliable email for communication and questionnaires.
排除标准
- •Unable to consent
- •Unable to read and complete questionnaires in English
- •Unable to sustain 30 minutes of moderate walking/activity at baseline (self-reported)
- •Use a mobility assistance device such as a walker/cane at baseline
- •Balance or stability problems
- •Patients on chronic opioids
研究组 & 干预措施
Standard of Care
Participants will receive standard postoperative instructions only
干预措施: Standard of Care (Other)
Active Recovery
Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises
干预措施: Active Recovery (Other)
结局指标
主要结局
Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)
时间窗: Baseline to 12 weeks post-surgery
The change in the Pelvic Floor Distress Inventory-20 (PFDI-20) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how much symptoms bother them from 0 (not at all) to 4 (quite a bit)
Change in the Short Form Health Survey (SF-36)
时间窗: Baseline to 12 weeks
The change in the Short Form Health Survey (SF-36) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their overall health. Scores can range from 0 to 100
Change in the Patient Health Questionnaire (PHQ-9)
时间窗: Baseline to 12 weeks post-surgery
The change in the Patient Health Questionnaire (PHQ-9) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how frequently problems have bothered them from 0 (not at all) to 4 (nearly every day)
Change in the Patient Global Impression of Improvement (PGI-I)
时间窗: Baseline to 12 weeks post-surgery
The change in the Patient Global Impressions of Improvement (PGI-I) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their symptoms from 1 (very much better) to 7 (very much worse)
次要结局
未报告次要终点
研究者
Sara Cichowski
Principal Investigator
Oregon Health and Science University