Laparoscopic Lateral Suspension Versus Laparoscopic Sacrocolpopexy for Post-Hysterectomy Vaginal Cuff Prolapse: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Anatomical Success (Point C of POP-Q System)
研究概览
简要总结
This study is a randomized controlled trial comparing two minimally invasive surgeries-laparoscopic lateral suspension and laparoscopic sacrocolporopexy-for women who develop vaginal cuff prolapse after hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses support after the uterus is removed, which can cause discomfort, bulging, or urinary and bowel problems.
The goal of this study is to determine which surgical approach is safer, more effective, and improves quality of life for patients. Women enrolled in the trial will be randomly assigned to one of the two surgeries, and outcomes such as prolapse recurrence, complications, recovery time, and patient satisfaction will be carefully monitored.
By comparing these two techniques, this study aims to provide clear guidance for surgeons and patients to make informed decisions about the best surgical treatment for post-hysterectomy vaginal cuff prolapse.
详细描述
This study is a randomized controlled trial (RCT) designed to compare the outcomes of two minimally invasive surgical techniques-laparoscopic lateral suspension and laparoscopic sacrocolpopexy-for the treatment of vaginal cuff prolapse following hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses its normal support after the uterus has been removed, leading to symptoms such as a sensation of vaginal bulging, pelvic pressure, urinary or bowel dysfunction, and discomfort during daily activities or sexual intercourse.
Eligible participants are women who have previously undergone hysterectomy and are experiencing symptomatic vaginal cuff prolapse. Participants will be randomly assigned to undergo either laparoscopic lateral suspension or laparoscopic sacrocolpopexy. Both procedures are performed using minimally invasive laparoscopic techniques, which typically result in smaller incisions, less pain, and faster recovery compared to traditional open surgery.
The study will assess multiple clinical and patient-reported outcomes, including:
Anatomical success: Prevention of prolapse recurrence at follow-up visits.
Functional outcomes: Improvement in urinary, bowel, and sexual function.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18 years.
- •History of hysterectomy (any approach: abdominal, vaginal, or laparoscopic).
- •Symptomatic vaginal cuff prolapse (POP-Q stage ≥ II).
- •Able to provide written informed consent.
- •Willing and able to comply with study procedures and follow-up visits.
排除标准
- •Prior sacrocolpopexy or lateral suspension surgery.
- •Active pelvic infection or untreated malignancy.
- •Severe cardiopulmonary or systemic disease that contraindicates laparoscopic surgery.
- •Known allergy to mesh materials used in the procedures.
- •Inability to complete patient-reported questionnaires due to cognitive or language barriers.
- •Concurrent pelvic organ prolapse requiring additional surgical repair beyond vaginal cuff suspension.
研究组 & 干预措施
Laparoscopic Sacrocolpopexy
干预措施: Laparoscopic Sacrocolpopexy (Procedure)
Laparoscopic Lateral Suspension
干预措施: Laparoscopic Lateral Suspension (Procedure)
结局指标
主要结局
Anatomical Success (Point C of POP-Q System)
时间窗: 12 months post-surgery
Vaginal cuff support measured objectively using POP-Q system, focusing on point C (position of the vaginal apex relative to the hymen). Success is defined as point C remaining above the hymen at follow-up by a blinded examiner.
次要结局
- Operative Time(During surgery)
- Postoperative Hospital Stay(From the day of surgery through hospital discharge (an expected average of 2 days))
- Postoperative Complications(Up to 12 months post-surgery)
- Pelvic Floor Distress Inventory (PFDI-20)(Preoperative and 12 months post-surgery)
- Pelvic Floor Impact Questionnaire (PFIQ-7)(Preoperative and 12 months post-surgery)
- Patient Global Impression (PGI) Scale(Preoperative and 12 months post-surgery)
研究者
Ozan Karadeniz
Principal Investigator
Başakşehir Çam & Sakura City Hospital