Unilateral Versus Bilateral High Uterosacral Ligament Suspension Following vNOTES Hysterectomy for Apical Pelvic Organ Prolapse: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Anatomical Success Rate
研究概览
简要总结
This study aims to compare unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse. The objective is to evaluate the effectiveness and safety of both surgical approaches in terms of anatomical outcomes and postoperative complications. The results of this study may help guide surgical decision-making in the management of pelvic organ prolapse.
详细描述
Pelvic organ prolapse is a common condition affecting women, often requiring surgical intervention. Vaginal hysterectomy combined with high uterosacral ligament suspension is a widely used technique for apical support. However, there is ongoing debate regarding whether unilateral or bilateral suspension provides better anatomical and clinical outcomes.
This study is designed as a comparative clinical study evaluating unilateral versus bilateral high uterosacral ligament suspension performed following vaginal hysterectomy. Patients undergoing surgery for pelvic organ prolapse will be included and assigned to one of the two surgical approaches according to the study design.
The primary objective is to compare anatomical success rates between the two techniques. Secondary outcomes include perioperative complications, recurrence rates, and postoperative functional outcomes.
The findings of this study are expected to provide evidence regarding the optimal surgical approach for uterosacral ligament suspension and contribute to improving patient outcomes in pelvic organ prolapse surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study; neither participants nor investigators are blinded to the surgical technique performed.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 years and older
- •Diagnosis of pelvic organ prolapse requiring surgical treatment
- •Planned vaginal hysterectomy with high uterosacral ligament suspension
- •Ability to provide informed consent
排除标准
- •Previous pelvic organ prolapse surgery involving apical support
- •Presence of pelvic malignancy
- •Active pelvic infection
- •Severe comorbidities contraindicating surgery
- •Pregnancy
研究组 & 干预措施
Unilateral High Uterosacral Ligament Suspension
Participants undergo unilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse.
干预措施: High Uterosacral Ligament Suspension (Procedure)
Bilateral High Uterosacral Ligament Suspension
Participants undergo bilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse.
干预措施: High Uterosacral Ligament Suspension (Procedure)
结局指标
主要结局
Anatomical Success Rate
时间窗: 12 months postoperatively
Anatomical success defined as the absence of pelvic organ prolapse at or beyond the hymen, assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.
次要结局
- Prolapse Recurrence Rate(12 months postoperatively)
- Operative Time(Intraoperative)
- Intraoperative Complications(During surgery)
- Postoperative Complications(Up to 30 days postoperatively)
- Functional Outcomes(6 and 12 months postoperatively)
研究者
Abdurrahman Sengi
"Resident in Obstetrics and Gynecology"
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital