Preoperative POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension
试验速览
- 阶段
- 不适用
- 入组人数
- 335
- 试验地点
- 2
- 主要终点
- Surgical success at 2 years after surgery
研究概览
简要总结
The objective of the Preoperative Pelvic Organ Prolapse Quantification (POPQ) versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension (PREPARE) trial is to compare surgical outcomes of POPQ-based surgery with simulated apical support-based surgery for anterior or posterior vaginal wall prolapse at the time of transvaginal apical suspension.
详细描述
The PREPARE trial is a prospective, randomized trial conducted with the aim to determine non-inferiority of the primary outcome between POPQ-based surgery and simulated apical support-based surgery for anterior or posterior vaginal wall prolapse. Participants will undergo transvaginal surgery for prolapse, including the assigned procedure for anterior or posterior vaginal prolapse under general or spinal anesthesia. Concomitant procedures will be performed as intended prior to surgery. Women with a uterus in situ will undergo hysterectomy and all women will receive transvaginal vault suspension, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension with both delayed absorbable and permanent sutures, according to the preference of surgeon. Incontinence surgery will also be performed for women with documented urodynamic stress incontinence.
A standardized protocol for enrollment, treatment and data collection will be employed by all sites. The study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. However, it is our intent that when feasible and ethical, all outcomes assessors and the subjects will be blinded to the treatment assignment. Postoperative follow-up will take place after 5 weeks and 6, 12, and 24 months. Patients will undergo a standard gynecological examination including POPQ and fill in questionnaires.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •POPQ stage 2-4 prolapse
- •Descent of vaginal apex or cervix at least ½ way into vaginal canal (i.e. POPQ point C ≥ -TVL/2)
- •Correction of either anterior or posterior vaginal wall prolapse under simulated apical support (i.e. from stage 2 or greater to stage 0 or 1)
- •Vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the PFDI-20)
- •Vaginal reconstructive surgery is planned, including a vaginal apical suspension procedure
排除标准
- •Large pelvic mass
- •Previous prolapse surgery
- •Known malignancy
- •Two or more inpatient hospitalizations for medical comorbidities in the previous year
- •Subject wishes to retain her uterus
- •Subject is unable and unwilling to participate in
结局指标
主要结局
Surgical success at 2 years after surgery
时间窗: From date of surgery until the date of first documented failure, assessed up to 2 years after surgery
surgical success is defined as the absence of all of the following criteria: (1) anterior or posterior vaginal descent beyond the hymen (i.e., point Ba or Bp \>0); (2) descent of the vaginal apex beyond the half-way point of vagina (i.e., point C \> -1/2×total vaginal length); (3) vaginal bulge symptoms; (4) re-treatment for prolapse by either surgery or pessary.
次要结局
- Rate of anterior or posterior colporrhaphy(At date of surgery)
- Change of PFDI-20 scores(From baseline to 2 years after surgery)
- Operating times(At date of surgery)
- Length of hospital stay(From date of admission to date of discharge, estimated average 4 days)
- Change of POPQ values(From baseline to 2 years after surgery)
- Change of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)-12 scores(From baseline to 2 years after surgery)
- Rate of adverse events(From date of surgery to 2 years after surgery)
- Change of pelvic floor impact questionnaire (PFIQ-7) scores(From baseline to 2 years after surgery)
- Estimated blood loss(At date of surgery)
研究者
Myung Jae Jeon
Associate professor
Seoul National University Hospital