Patient Satisfaction With Two and Six Week Postoperative Follow up Appointments After Benign Minimally Invasive Hysterectomy Versus Two Week Postoperative Visit Alone: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Patient satisfaction
研究概览
简要总结
This prospective, randomized control trial will evaluate patient satisfaction with the number of postoperative follow up visits after minimally invasive hysterectomy for the treatment of non-cancerous conditions at an urban academic hospital in Louisville, Kentucky. Patients will be randomized to receive either a two and six week postoperative follow up visits versus a postoperative follow up visit at six weeks alone.
详细描述
The objective of follow up appointments following benign gynecologic surgery is to ensure adequate postoperative recovery, assess additional patient concerns, and to identify and manage any delayed postoperative complications. There is limited literature addressing short-term postoperative follow up for benign gynecologic surgery, particularly those performed through a minimally invasive approach.
The benefits of minimally invasive surgery includes shorter operative time, reduced hospital stay, improved cosmesis, and faster recovery especially when combined with enhanced recovery after surgery (ERAS) protocols. However, this does not negate the need for follow up. Although no consensus exists on the appropriate frequency and number of postoperative appointments, there is no debate on its value.
Due to lack of evidence on this issue, the number and frequency of postoperative appointments is currently dependent on surgeon preference, type of procedure performed and complications encountered intraoperatively and postoperatively, which could lead to patient confusion and unnecessary cost and hassle.
For this reason, investigation of outcomes based on the number and frequency of postoperative follow up visits may improve optimal patient satisfaction, improve compliance and provide early detection of postoperative complications. Such knowledge could serve to mitigate efforts to develop and implement protocols to improve compliance with postoperative follow-up care, potentially reduce emergency room visits, readmissions, empower patients and reduce cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients of University of Louisville gynecology providers age 18-70 who are planning to undergo a minimally invasive hysterectomy for benign indications.
- •Incident surgery must be performed at the University of Louisville Hospital (or affiliated hospital attended by a provider affiliated with the academic department).
排除标准
- •Patients with decreased mental capacity who are unable to consent.
- •Patients who do not have sufficient English proficiency to complete or understand informed consent for the surgery or study questionnaires.
- •Patients with unreliable access to a telephone.
- •Patients with significant medical comorbidities that would necessitate more frequent follow up.
- •Patients for whom the planned number of follow ups have been pre-determined at the pre-operative visit due to a certain medical need or condition.
- •Patients who report an inability to comply with postoperative follow up in either group to which they could be randomized.
- •Women who decide at their preoperative visit they do not desire or cannot undergo benign gynecologic surgery as scheduled.
- •Women who have medical contraindication to undergoing the benign gynecologic surgery that was planned prior, as determined in their best interest by their provider
结局指标
主要结局
Patient satisfaction
时间窗: 6 weeks
To assess patient satisfaction with the number of postoperative follow up office visits after minimally invasive hysterectomy for benign indications utilizing the Surgical Care - Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician \& Group Survey.
次要结局
- Postoperative complication rate(6 weeks)
研究者
Shan Biscette
Associate Professor of Gynecology
University of Louisville