Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
研究概览
简要总结
The aim of this study is to assess:
- Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time.
- Evaluate patients' outcome as regard bladder function.
in order to preserve the function of the bladder and the rectum, it is necessary to modify the traditional procedures, so as to identify the precise anatomical information directing the technique for optimal preservation of bladder function at the time of radical hysterectomy.
The laparoscopic technique offers several well-known advantages. Under the magnified view of the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and precise dissection of the para-cervical structures and areolar tissue, including the blood vessels and the nerves.
Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as this qualification could prohibit long-term bladder and voiding dysfunction during nerve-sparing radical hysterectomy
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
- None
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
- •Age > 18 years.
- •Karnofsky > 80, or American Society of anaethesiology (ASA) I-II
- •Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging.
- •Stage II, III endometrial cancer
排除标准
- •Non Invasive Cancer
- •Bladder dysfunction detected prior to surgery.
- •Previous pelvic lymphadenectomy.
- •Tumour recurrence
- •Incomplete surgery, unresectable lesion.
研究组 & 干预措施
Group (A)
laparoscopic nerve sparing radical hysterectomy type III/C1
干预措施: laparoscopic nerve-sparing radical hysterectomy-type III/C1 (Procedure)
Group (B)
laparoscopic radical hysterectomy type III/C2
干预措施: laparoscopic radical hysterectomy (type III/C2). (Procedure)
结局指标
主要结局
Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
时间窗: 1 month
Duration of postoperative catheterization untill PVR urine volume is less than 100 ml
次要结局
- Intraoperative complications(During Surgery)
- Operative time(Day of surgery)
- Late postoperative complication(more than 30 days postoperative)
- Bladder training exercise(1 month)
- Blood loss(Day of surgery)
- Early postoperative complication(30 days)
研究者
Osama Mohammad Ali ElDamshety
surgical oncology
Mansoura University