Comparing Retroperitoneal Tunneling Versus Dissection Technique During Robotic Assisted Sacrocolpopexy for Pelvic Organ Prolapse
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
- Operative Time (minutes)
研究概览
简要总结
The purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus dissection technique during robotic assisted sacrocolpopexy (RA SCP).
详细描述
Women with symptomatic, stage II to IV POP who plan RA SCP at UTMB Health will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessments will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to tunneling versus dissection technique during RA SCP with the total sample size of 40 female subjects (20 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. Subsequently, the subject will have postoperative follow up at 2 weeks, 6 weeks and 3 months
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females at least 18 years of age at the time of consent.
- •Able to understand and read English
- •Able and willing to provide written informed consent
- •Able to comply with the follow-up study protocol, per clinician judgment
- •Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV.
- •RA SCP as desired surgical approach to correct apical prolapse
排除标准
- •Females who are pregnant, or intend to become pregnant during the study
- •Texas Department of Criminal Justice prisoners
- •A known history of sensitivity to propylene mesh
- •Prior prolapse repair surgery using mesh (abdominal, vaginal or rectal)
- •Active or chronic systemic infection including any pelvic infection, abscess
- •Has had history of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis
- •Prior or current pelvic radiation, or chemotherapy.
- •Not a candidate for general anesthesia
- •History of systemic connective tissue or musculoskeletal disorders (scleroderma, SLE, Marfan's syndrome, Ehlers Danlos, polymyositis, Lambert Eaton syndrome etc)
- •History of neurologic condition affecting bladder function (multiple sclerosis, spinal cord injury, stroke with neurologic deficit)
结局指标
主要结局
Operative Time (minutes)
时间窗: Intraoperative time
Operating time for dissection technique: includes dissection and suturing time. The dissection time starts when the robotic instruments are used to extend the retroperitoneal incision (created during the presacral space dissection) and ends when the extension reaches the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum at the presacral space and ends when the suture is cut after the presacral space, retroperitoneal space and the peritoneum covering the mesh are completely re-approximated. Operating time for tunneling technique: includes tunneling and suturing time. The tunneling time starts when the robotic instruments are used to undermine the peritoneum and ends when the tunnel is completely created, reaching the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum to close the presacral space and ends when the suture is cut after the peritoneum covering the mesh is completely re-approximated.
次要结局
- Decision Regret Scale (DRS)(6 weeks postoperatively and 12 weeks postoperatively)
- Patient Global Impression of Improvement PGI-I(Baseline, 6 weeks postoperatively and 12 weeks postoperatively)
- POP-Q exam(Baseline, 6 weeks postoperatively and 12 weeks postoperatively)
- Pelvic Floor Distress Inventory PFDI-20(Baseline, 6 weeks postoperatively and 12 weeks postoperatively)
- Pelvic Floor Impact Questionnaire PFIQ-7(Baseline, 6 weeks postoperatively and 12 weeks postoperatively)
- Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12(Baseline, 6 weeks postoperatively and 12 weeks postoperatively)
- Satisfaction with Decision Scale (SDS)(6 weeks postoperatively and 12 weeks postoperatively)
- Clavien-Dindo classification for operative complication(2 weeks, 6 weeks postoperatively and 12 weeks postoperatively)