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临床试验/NCT03445442
NCT03445442已完成不适用

Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

Centre Hospitalier Universitaire de Nice0 个研究点目标入组 214 人开始时间: 2011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
214
主要终点
Post-operative complications

研究概览

简要总结

The investigator aimed to compare various pelvic floor repairs in female aged from 70 to 80 years old, to see which procedure in terms of treatment-related complications of SCP, VMR and NTR by comparing the operative and functional outcomes in this patient population.

详细描述

Pelvic organ prolapse (POP) is a global health care issue that could have a significant impact on pelvic floor function and quality of life (QOL), while seldom having the potential to be life-threatening. Prevalence of POP increases with age. In women older than 80, 11% undergo a surgical procedure. The incidence of degenerative diseases and multiple co-morbidities increases with age, and advanced age is also associated with an increase in morbidity generally for gynecologic procedures. Furthermore, greater comorbidity beforehand can predispose patients to postoperative complications such as bleeding, hematoma, pain, infectious. As a result hospital stays are longer and the surgical results are compromised.

Surgical techniques should optimize functional results and minimize complications. In POP surgery, younger women are good candidates for sacrocolpopexy (SCP), because of the improved long term functional result, while women older than 80 may have a satisfactory outcome with fewer complication with a vaginal repair with mesh (VMR) or native tissue (NTR). The increasing prevalence of POP, and the increasing population of women aged 70-80 requires an evaluation of the appropriate surgical management since women in this age group may be candidates for all types of surgical repair.

研究设计

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

入排标准

年龄范围
70 Years 至 80 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with a pelvic organ prolapse
  • Patients aged between 70 and 80 years old
  • Patients with symptomatic anterior, apical and/or posterior compartment prolapse, stage 2 or greater

排除标准

  • Patients with a previous history of pelvic surgery for a cancer diagnosis are excluded
  • Patients with a surgical repair specific to the existing defect site (For group 2)

结局指标

主要结局

Post-operative complications

时间窗: 12 months follow-up

All complications are recorded, corresponding to Clavien Dindo classification.

次要结局

  • Surgical satisfaction(12 months follow-up)
  • Anatomical success rate(12 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

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