The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Success rate of access platform establishment
研究概览
简要总结
The modified vNOTES hysterectomy was accomplished and validated for efficacy and safety using a multi-access vaginal confinement instrument with a fully visualised vaginal access platform.
详细描述
A multi-center prospective randomized controlled trial was conducted to evaluate the efficacy and safety of the vNOTES technique in patients with uterine fibroids who were scheduled for total hysterectomy. The patients were randomly assigned to the vNOTES group (experimental group) and the traditional vNOTES group (control group). The access platform was established using a visualization method or the traditional laparoscopic method, and the surgical operation was completed. The time required to establish the platform, the amount of bleeding, the total surgical time, the anesthesia indicators, complications, and follow-up indicators were recorded, and the effectiveness and safety of the technique were evaluated.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≤ 60years old
- •Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
- •BMI ranges from 18.5 to 27.9kg/m2;
- •Informed consent signed by the subject himself or his legal representative.
排除标准
- •Pregnant and lactating women;
- •asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
- •Preoperative examination for malignant possibility
- •Uterine volume ≥20 weeks, history of pelvic inflammatory disease, severe endometriosis, degree III or IV uterine prolapse; Previous surgical history of intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, and pelvic abdominal tumor; Gynecological examination of the uterine and rectal fossa is completely closed;
- •Patients known to have severe hepatic or renal dysfunction;
- •Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;
- •complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, Cushing's syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders;
- •patients with acute infection;
- •Known to have participated in any other clinical trial or taken hormone therapy within 3 months;
- •who cannot sign the informed consent;
- •For those with known or suspected poor compliance who could not complete the trial.
结局指标
主要结局
Success rate of access platform establishment
时间窗: End of surgery
Success is defined as opening the vaginal vault and entering the abdominal cavity to create stable abdominal pressure
次要结局
- Tightness of equipment(End of surgery)
- Stability of equipment(End of surgery)
- Controllability of equipment(End of surgery)
- Time of establishment of the access platform(End of surgery)
- Total time of surgery(End of surgery)
- Total surgical bleeding volume(End of surgery)
- The amount of bleeding during the process of establishing the platform(End of surgery)
- Surgical complications(6 months after surgery)
- Length of hospital stay(6 months after surgery)
- Heart rate during surgery(End of surgery)
- Pain VAS score(6 months after surgery)
- The Patients' life quality postoperative(6 months after surgery)
- blood pressure during surgery(End of surgery)
研究者
Jing Liang
Director of Obstetrics and Gynecology
China-Japan Friendship Hospital