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临床试验/NCT04179955
NCT04179955进行中(未招募)不适用

Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Mayo Clinic
入组人数
80
试验地点
1
主要终点
Intraoperative cost of surgery

研究概览

简要总结

Robotic sacrocolpopexy (a procedure for female pelvic organ prolapse) has been demonstrated to have equivalent surgical outcomes to open abdominal sacrocolpopexy and has been previously deemed more cost effective due to the longer hospital course following open procedures. The total cost of these procedures, including all costs of hospitalization as well as costs associated with the 30 days following surgery have previously been evaluated by the investigators. However, previous research is lacking in both the specific cost components that contribute to intraoperative cost of surgery as well as the patient perceived outcomes following these two procedures. This project aims to evaluate the marginal costs of surgery and to survey sacrocolpopexy patients to evaluate their satisfaction with outcomes and surgical scars.

详细描述

Abdominal sacrocolpopexy (ASC) is the gold standard operation to treat pelvic organ prolapse. The open approach has been associated with prolonged hospital stay and higher peri-operative morbidity, leading many providers to prefer a robotic approach. Even though robotic ASC overcomes many of the technical hurdles associated with laparoscopy, it is expensive, and it achieves cost effectiveness compared to open only because of large discrepancies in length of stay. Preliminary data at our institution suggests that with the introduction of ERAS, decreases in hospital stay after abdominal surgery have driven down the discrepancy in length of stay between open (1.8 days) and robotic (1.4 days) ASC. Previous analysis accounted for differences in OR time as well as postoperative stay. However, this cost data is obtained from data on billed charges rather than a summation of actual costs sustained; data on specific incurred costs is scant in the literature. Robotic surgery requires equipment and resources which also increase the price of the procedure. Specifically, Da Vinci robots are priced at $1.4 million, require $120,000 in annual maintenance contracts, and the cost of disposable instruments can reach $2000 per case. Instruments and disposable materials, while contracted at Mayo, do have published prices that may be used to better quantify intraoperative procedural costs.

In addition to questions about the cost effectiveness of robotic versus abdominal sacrocolpopexy, data on patient satisfaction comparing the two procedures is minimal. While abdominal and robotic approaches have similar efficacy, patient perceived equivalence has been largely assumed. Additionally, the literature frequently lists improved cosmesis as a benefit to robotic surgery, yet the studies on scar satisfaction between the two approaches are lacking.

Hypothesis

Intraoperative costs of abdominal sacrocolpopexy are significantly less than those in the robotic approach. However, patients who undergo robotic sacrocolpopexy have improved scar satisfaction and equivalent perceived surgical satisfaction.

This is a prospective cohort study of intraoperative time and materials in open versus robotic ASC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women ≥ 18 years of age
  • •Undergoing abdominal or robotic sacrocolpopexy with or without posterior vaginal repairs
  • •Willing and able to provide signed informed research consent
  • •Concurrent and prior hysterectomy

排除标准

  • •Repeat sacrocolpopexy
  • •Concurrent sling procedure
  • •Concurrent Pouch of Douglas repairs
  • •Concurrent anterior vaginal wall repairs

结局指标

主要结局

Intraoperative cost of surgery

时间窗: SIx weeks postop

Cost of surgery will be ascertained by summing marginal costs of surgery, including operative and anesthesia time, instruments and medications

Patient Scar Assessment

时间窗: Six weeks postop

Patient satisfaction with their surgical scars from sacrocolpopexy will be assessed via the Patient Scar Assessment Survey (POSAS). This validated scar assessment scale ranges from 6 to 60, with higher scores indicating worse scar aesthetics and symptoms.

次要结局

  • Surgical satisfaction(Six months postop)
  • Sexual function(Six months postop)
  • Patient Scar Assessment(Six months postop)
  • Urinary symptoms(Six months postop)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emanuel Trabuco

Associate Professor of Obstetrics and Gynecology

Mayo Clinic

研究点 (1)

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