Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility and safety of the transvaginal operation
研究概览
简要总结
Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine.
Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •given informed consent
- •sigmoid diverticulosis (two or more attacks)
- •sigmoid diverticulitis (Hinchey I and II)
排除标准
- •emergency surgery
- •liver-malfunction or coagulation disorders
- •acute diverticulitis (Hinchey III and IV)
- •malignancy
- •acute vaginal infection
- •refusal of mandatory preoperative gynecological examination
- •pregnancy
- •endometriosis
- •previous surgery of colon and rectum
- •strongly retroflexed uterus
- •acute pelvic disorders, infection
结局指标
主要结局
Feasibility and safety of the transvaginal operation
时间窗: 30 days
次要结局
- Long-term life quality and sexual dysfunction(3 year)