Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL)
研究概览
简要总结
Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with primary symptomatic uterine prolapse
- •≥ 18 years of age
- •Considering pelvic reconstructive surgery
排除标准
- •Unwillingness to be randomized to one of two surgical approaches
- •Pregnant or planning to maintain their future fertility
- •Unable to have general anesthesia
- •Currently undergoing chemotherapy OR has current or history of pelvic radiation
- •Previous adverse reaction to synthetic mesh
- •Recent history of abnormal paps (past 10 years)
- •Cervical or uterine cancers
- •Previous hysterectomy
- •Previous central vault or uterine prolapse repair
- •Uterus ≥ 14 weeks size
- •Uterine cancer
- •History of significant pelvic adhesive disease
- •Elongated cervix (length D to C > 6cm)
- •Fibroid ≥ 7cm
- •Post menopausal with enlarged uterus
结局指标
主要结局
Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL)
时间窗: 24 months
A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
时间窗: 24 months
This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).
Absence of re-treatment for prolapse at 2 years
时间窗: 24 months
次要结局
- Changes in POPQ measurements(baseline, 6 week, and 3, 12, and 24 months)
- Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment(baseline, 3, 12, and 24 months)
- Change in patient reported sexual questionnaire, PISQ(baseline, 3, 12 and 24 months)
- Frequencies of surgical and post-operative complications(up to 2 years post-operatively)
研究者
Vatche Arakel Minassian
Director of Urogynecology
Brigham and Women's Hospital