Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Subjective cure rate of prolapse
研究概览
简要总结
The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q >2) at 1 year and yearly up to 2 years.
详细描述
Primary and secondary endpoints:
Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.
Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.
The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.
Project design: The investigators will perform an international multicentre single-blind randomized controlled trial with participating our tertiary referral hospital.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse
排除标准
- •Women not eligible for surgery for medical or anesthesiological reasons
- •Inability to comprehend questionnaires
- •Inability to give informed consent
- •Inability to return for a review
- •Prior laparoscopic prolapse repair
- •Prior vaginal mesh prolapse procedure
- •Severe cardiovascular or respiratory disease
- •Women who don't want uterine preserving surgery
- •Pregnancy
- •Age <18 years, Age >45 years
研究组 & 干预措施
Laparoscopic Lateral Suspension Group (LLS)
Anterior and apical prolapse repair via LLS
干预措施: LLS versus LP (Procedure)
Laparoscopic Pectopexy (LP)
Anterior and apical prolapse repair via LP
干预措施: LLS versus LP (Procedure)
结局指标
主要结局
Subjective cure rate of prolapse
时间窗: [ Time Frame: 12 months after intervention ]
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
Objective success
时间窗: [ Time Frame: 12 months after intervention ]
Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total
次要结局
- Pelvic Floor Distress Inventory (PFDI - 20)([ Time Frame: 12 months after intervention ])
- Failure (%)([ Time Frame: 12 months after intervention ])
- Complications([ Time Frame: 12 months after intervention ])
- Prolapse-related Quality of life([ Time Frame: 12 months after intervention ])
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)([ Time Frame: 12 months after intervention ])
- Incontinence Impact Questionnaire (IIQ-7)([ Time Frame: 12 months after intervention ])
研究者
Ozan Karadeniz
Principal investigator
Kanuni Sultan Suleyman Training and Research Hospital