Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Recurrence of anatomical anterior vaginal wall prolapse
研究概览
简要总结
This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery.
They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone .
Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.
详细描述
Eligible patients will be women with symptomatic anterior and apical prolapse with hiatal ballooning or levator ani injury eligible for vaginal surgical treatment.
At the time of the indication for surgery, anatomical severity of the prolapse (according to the Pelvic Organ Prolapse Quantification System (POP-Q) scale) and the symptoms of prolapse and sexual function, as well as their impact on the quality of life of the patient, are evaluated using validated questionnaires "Pelvic Floor Impact Questionnaire (PFIQ)", "Pelvic organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)"and "European Quality of Life-5 Dimensions Questionnaire (EQ5D)". Anatomical severity of the prolapse will be also evaluated by ecography described as follows.
Three-dimensional 3D/4D transperineal ultrasound (TPS) will be performed using a GE Voluson® ultrasound system (GE Medical Systems) with a RAB 8-4-MHz transducer at an acquisition angle of 85°.
TPS will be performed with the probe covered with a powder-free glove and applied in the midsagittal plane to the introitus using moderate pressure. Volumes are acquired at rest, on maximum pelvic floor muscle contractility and during maximal Valsalva maneuver. Patients perform Valsalva for at least 5 s, and the best of three volumes is used for analysis. Using visual biofeedback, an attempt is made to correct for levator co-activation by requesting the women observe the narrowing and widening of the levator hiatus during the maneuvers.
3D volumes are measured offline using GE 4 Dimension View (GE Medical Systems). Using the best Valsalva maneuver, pelvic organ descent measurements are obtained relative to a horizontal line from the inferior margin of the pubic symphysis. Levator hiatal area is assessed in the plane of minimal hiatal dimensions.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatic POP with indication of vaginal surgery.
- •Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.
- •Women ≥18 years old.
- •Women wishing to complete a 36-month follow-up.
- •Understand and accept the study procedures and sign the informed consent.
排除标准
- •Women with previous pelvic floor or prolapse surgery
- •Women with POP grade IV
- •Women with chronic pelvic pain.
- •Not being able to understand the nature of the study and/or the procedures to be followed.
- •Not signing the informed consent
结局指标
主要结局
Recurrence of anatomical anterior vaginal wall prolapse
时间窗: 36 months
Defined as point Ba POP-Q stage ≥II by clinical examination
次要结局
- Difference between groups in anatomical prolapse(36 moths)
- Differences between groups in symptomatic recurrence(36 months)
- Differences between groups in sexual functioning.(36 months)
- Differences between groups in hospital stay(36 months)
- Differences between groups in surgical complication rate.(36 months)
- Differences between groups in quality of Life(36 months)
- Differences between groups in operative time(36 months)
- Differences between groups in reintervention rate(36 months)