NCT01830738终止不适用
Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique : a Prospective, Randomized, Multicenter Study Evaluating the Length of Hospital Stay
Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 6
- 主要终点
- Length of hospital stay in hours
研究概览
简要总结
The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.
详细描述
The secondary objectives are to compare the following between the two arms of the study:
- the difference between the real discharge date and the theoretical discharge date
- measures related to intraoperative bleeding
- operating time
- postoperative pain
- quality of life
- abdominal wall complication rates
- rates of further surgery and rehospitalization
- use of material resources in the operating room
- average costs of hospital stay
- Costs of rehospitalization at 1 year
- Indirect costs
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must have given her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 12 months of follow-up
- •The patient is declared fit by the anesthetist for an intervention by laparoscopy
排除标准
- •The patient is not available for 12 months of follow-up
- •The patient is participating in another study or is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient is not insured or beneficiary of a health insurance plan
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient cannot read French
- •Patient with a history of pelvic radiotherapy
- •Patient with a history of pelvic surgery or serious risk of major adhesions
- •The patient is pregnant
- •Contraindications for anesthesia for either surgical technique
- •Promontofixation or lymphadenectomy
- •No associated procedure other than morcellation or vaginal suture for extracting the hysterectomy specimen, unilateral or bilateral oophorectomy
- •The patient has a known or suspected allergy to polyurethane
- •Extended hysterectomy for neoplastic disease
结局指标
主要结局
Length of hospital stay in hours
时间窗: Maximum 1 month (usually 3 to 5 days)
次要结局
- Change in hemoglobin measure(Day 3 versus baseline)
- Change in hematocrit measure(Day 3 versus baseline)
- Difference in hours between real discharge time and theoretical discharge time(4 weeks)
- Questionnaire SF 36(12 months)
- Surgical conversion rate(Day 0 (during surgery))
- Estimatin of indirect costs(4 weeks)
- Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids(Day 0 (during surgery))
- Surgical time, from first incision to closing(Day 0 (during surgery))
- Visual analog scale for pain(3 times per day during hospitalisation (expected maximum of 3 to 5 days))
- Trocar site infection rate(4 weeks)
- Presence/absence of complications according to Clavien scale(12 months)
- Complication rate(12 months)
- Re-intervention/hospitalisation rate(12 months)
- Inventory of reusable material in the operating room and related costs.(Day 0 (after surgery))
- Estimation of direct costs(12 months)
研究者
研究点 (6)
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