A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse.
Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.
详细描述
Pelvic organ prolapse can be treated either conservatively or surgically. Patients who are unsatisfied with conservative treatment or with severe symptoms often seek for surgical intervention. Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic sacrohysteropexy is the current trend for laparoscopic surgery, with small incisional wound, fast recovery, and low recurrence rate as advantages. However, laparoscopic sacrohysteropexy is often regarded as time consuming and ous sometimes hazard given the complexity of surgical technique and the anatomy of the presacral region. Few cases with severe complications such as vascular injuries, sacral nerve root injuries, and diskitis had been reported with laparoscopic sacrohysteropexy in previous studies.
Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, is therefore proposed in our study. The most significant benefits of this novel approach include safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy of laparoscopic lateral uterine suspension and compare with the transvaginal sacrospinous ligament fixation with native tissue repair. Other results include safety and adverse events of laparoscopic lateral uterine suspension in long term follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •older than 21 years old.
- •uterine prolapse stage 2 at least, defined by C point distal to -1cm by POP-Q system.
- •patients willing to receive a uterine-preserving surgery for pelvic organ prolapse, and is suitable for anesthesia after evaluation.
- •patients who had or had not received conservative treatments for pelvic organ prolapse.
- •patients able and willing to finish the questionnaire evaluation.
排除标准
- •patient who had received a previous hysterectomy, or is planning on concomitant hysterectomy in the surgery for pelvic organ prolapse.
- •patient who had received a previous surgery for pelvic organ prolapse.
- •patient with history of adverse events following a synthetic mesh.
- •patients with chronic or acute pelvic pain.
- •patients who had received abdominal or pelvic irradiation.
- •patients who cannot receive either surgery due to comorbidity.
- •patients pregnant or with future plan of pregnancy.
- •patients with vaginal length less than 5cm.
结局指标
主要结局
Recurrence
时间窗: 5 years
Composite outcome of subjective and objective recurrence of uterine prolapse.
次要结局
- Sexual function outcome(5 years)
- Urodynamic outcome(6 months)
- Anatomical outcome(5 years)
- Functional outcome(5 years)
研究者
Yu Fang Huang
Professor Yu Fang Huang
National Cheng-Kung University Hospital