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临床试验/NCT03553511
NCT03553511Unknown不适用

Short and Long-term Outcomes After Total Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments Versus Vaginal Hysterectomy With McCall Culdoplasty for the Treatment of Stage II-III Pelvic Organ Prolapse.

Università degli Studi dell'Insubria0 个研究点目标入组 60 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Recurrence

研究概览

简要总结

The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. The risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons.

Techniques available to manage PHVP aim to ultimately suspend the vaginal vault. Approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication.

Data published so far do not allow to draw a firm conclusion about the best treatment to prevent PHVP for women undergoing hysterectomy for stage II-III pelvic organ prolapse. Considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with McCall culdoplasty for the treatment of stage II-III pelvic organ prolapse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Stage II-III pelvic organ prolapse
  • Bilateral preservation of the ovaries
  • Sexually active women

排除标准

  • Body Mass Index > 30
  • Strenuous activity (frequent heavy lifting)
  • Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities
  • Pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period

结局指标

主要结局

Recurrence

时间窗: 12 months after surgery

Vaginal vault prolapse

次要结局

  • Urinary impact questionnaire score (total score minimum: 0, maximum: 100)(12 months after surgery)
  • Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100)(12 months after surgery)
  • Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48)(12 months after surgery)
  • Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100)(12 months after surgery)

研究者

发起方
Università degli Studi dell'Insubria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Simone Laganà

Medical Doctor

Università degli Studi dell'Insubria

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