A Multicenter, Randomized, Prospective, Controlled Study Comparing Uterine Preserving Laparoscopic Lateral Suspension With Mesh Versus Laparoscopic Sacrocervicopexy in the Treatment of Uterine Prolapse: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Change from baseline POP-Q measurements (mm) at 12th month.
研究概览
简要总结
This study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Both procedures are known as sufficient uterus preserving methods. LLSM was introduced to be an alternative to others with avoiding dissection of promontory and therefore being safer, faster and feasible technique.
详细描述
Patient with uterine prolapse can participate in this study. A total of 44 women will be included. At random 22 patients undergo laparoscopic lateral suspension with mesh operation and 22 patients undergo laparoscopic sacrohysteropexy operation. Evaluation will take place during the surgery, at the postoperative visit after 4 weeks, 6th months and 12th months. Quality of life, degree of vaginal prolapse, safety, operation time and complications will be evaluated.
Subjective assessments will include Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS).
Objective assessments will include routine gynecologic sonography, Pelvic Organ Prolapse Quantification System (POP-Q) and pelvic floor biometry measured by transperineal sonography.
Transperineal sonography will include those measurements:
Urethral rotation, Pelvic organ descent, Hiatal Diameter and the Anatomical localization of apex.
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 (Care Provider, Outcomes Assessor)
盲法说明
Care provider will be blind to the operation type. Outcomes will be assessed by a gynecologist who will be blind to the operation type, indications and complications. Assessor has wide experience in urogynecological sonography.
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
- •>18 years old
- •> Symptomatic prolapse of central compartment with a Pelvic Organ Prolapse Quantitative (POP-Q) stage 2 associated or not with anterior or posterior compartment prolapse.
- •Patients who are not comfortable with using or refusing pessary
- •Wish to preserve the uterus
排除标准
- •Any cue for gynecologic oncological condition
- •Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse
研究组 & 干预措施
Lateral suspension
"Uterus-preserving Laparoscopic lateral suspension with mesh" technique will be performed in this arm.
干预措施: Uterus-preserving laparoscopic lateral suspension with mesh (Procedure)
Sacrocervicopexy
"Uterus-preserving Laparoscopic sacrocervicopexy with mesh" technique will be performed in this arm.
干预措施: Uterus-preserving laparoscopic sacrocervicopexy with mesh (Procedure)
结局指标
主要结局
Change from baseline POP-Q measurements (mm) at 12th month.
时间窗: 12 months for each participant
Prolapse degree; Point Ba/C/Bp
次要结局
- Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 12th month.(12 months for each participant)
- Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 12th month.(12 months for each participant)
- Change from baseline Pelvic Hiatus measurements (mm) at 12th month.(12 months for each participant)
- Change from baseline bladder neck mobility measurements at 12th month.(12 months for each participant)
- Operation time(Operation time will noted for each participant at the same day of the operation. Operation time will be determined with using a chronometer,from the time of first skin incision until the suturing the skin of the trocar entry, assessed up to 52 weeks.)
- Change from baseline Pelvic biometry measurements at 12th month.(12 months for each participant)
- Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 12th month.(12 months for each participant)
- Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 12th month.(12 months for each participant)
- Failure (%)(12 months for each participant)
- Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 12th month.(12 months for each participant)
- Complications(12 months for each participant)
研究者
MURAT YASSA
Principal Investigator
Fatih Sultan Mehmet Training and Research Hospital