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.
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
- 否
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
Antonio Simone Laganà
Medical Doctor
Università degli Studi dell'Insubria
