跳至主要内容
临床试验/NCT03607344
NCT03607344已完成不适用

Day-case Laparoscopic Sacrocolpopexy, a Compelling Option in Selected Patients

Centre Hospitalier Universitaire de Nice0 个研究点目标入组 30 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
The success rate of outpatient laparoscopic sacrocolpopexy

研究概览

简要总结

Facing the stakes of hospital beds, this study assessed day case variant technic of laparoscopic sacrocolpopexy with or without robotic assistant.

详细描述

Pelvic organ prolapse (POP) is an increasingly common functional disorder which affects approximately 40% of female population. Of these 12% are symptomatic and suffer of physical and emotional distress. 11% will undergo a surgical procedure. Since its introduction by Lane in 1982, Sacrocolpopexy (SCP) became the surgical "gold standard" for correcting vaginal vault .

With minimal invasive approach, SCP had an mean hospitalization time of 3 to 7 days .

With rising health care cost and its inherent economic burden, safe and viable options to reduce cost must be sought.

Day case surgery has developed rapidly in the USA since the 1970s, and has spread to Europe, especially in Great Britain. But the High Authority of Health in France found a delay in its development.

In view of the evolution of surgical and anesthetic techniques, and the low complication rate of SCP, it seemed natural to imagine that this intervention could be done in an ambulatory setting.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with symptomatic anterior, apical and/or posterior compartment prolapse
  • Patients with stage 2 or greater, according to the POP-Q classification
  • Patients with a body mass index (BMI) < 30
  • Patients with an American Society of Anesthesiologist (ASA) score < ou = 3.

排除标准

  • Patient with prior history of pelvic cancer surgery and radiotherapy of the pelvis

结局指标

主要结局

The success rate of outpatient laparoscopic sacrocolpopexy

时间窗: 1 month post-operative

The success rate of outpatient sacrocolpopexy is defined by the number of patients who leaves hospital at the day of surgery

次要结局

  • Post-operative adverses events(1 month post-operative)

研究者

申办方类型
Other
责任方
Sponsor

相似试验