Laparoscopic Supracervical Hysterectomy With Cervicosacropexy and Vaginally Assisted NOTES Hysterectomy With Uterosacral Ligament Suspension (Shull Technique): a Randomized Multicentric Prospective Comparison Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- time to mobilization with standing
研究概览
简要总结
This is a prospective, randomized multicenter study whose objective is to compare two surgical techniques routinely used at our center for the correction of pelvic organ prolapse (laparoscopic cervicosacropexis versus colposuspension sec. Shull using v-NOTES).
详细描述
patients with pelvic organ prolapse with a stage greater than or equal to stage 2 for the apical compartment who are candidates for surgical correction will be randomized and assigned to one of two treatment groups. The aim is to compare the anatomical, surgical and anesthesiological outcomes between these two surgical techniques, both of which are commonly used in clinical practice for the correction of this type of prolapse.
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 (Investigator, Outcomes Assessor)
盲法说明
The 6-week examination and review will be performed by the surgeon with all study data and future visits completed by blinded co-authors (Different surgeon or Urogynecology fellows) who will be unaware of group allocation.
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
- •consecutive women referred to one of the participating centers with symptomatic stage 2 or greater (point C≥ -1 pelvic organ prolapse quantification POP-Q) apical prolapse (uterovaginal) with or without anterior and posterior compartment prolapse will be eligible for inclusion (Criteria for which patients in clinical practice are candidates for one of the two interventions under study)
排除标准
- •age <18 years, BMI > 30,
- •previous hysterectomy,
- •inability to comprehend questionnaires, to give informed consent and to return for review,
- •unable to undergo general anesthesia,
- •prior laparoscopic prolapse repair or vaginal mesh prolapse procedure,
- •desire for future pregnancy or current pregnancy diagnosis
- •severe respiratory comorbidity,
- •ASA III patients,
- •need for concomitant anti-incontinence procedure.
结局指标
主要结局
time to mobilization with standing
时间窗: immediately post-operative
Time it takes the patient to mobilize to standing independently
hospital stay
时间窗: immediately post-operative
hours of post-operative stay
recurrence of prolapse in the anterior and posterior compartments when present
时间窗: at 3 months;
post-operative pain
时间窗: at 12 hours post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
postoperative complications
时间窗: from surgery to 3 motnhs follow.up
assessed using Clavien-Dindo classification
sexual function
时间窗: 3 months
assessed by TVL measure
recurrence of prolapse in apical compartment
时间窗: at 6 weeks
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
anesthesiological parameters
时间窗: intraoperative
End tidal CO2 (carbon dioxide) assessement
operating time
时间窗: intraoperative
from skin/vaginal incision to end of skin/vaginal suture
patient satisfaction
时间窗: at 3 months
assessed by P-QoL validated questionnaire
次要结局
未报告次要终点
研究者
Tommaso Simoncini
Principal Investigator
Azienda Ospedaliero, Universitaria Pisana