Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Length of postoperative hospital stay
研究概览
简要总结
This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.
详细描述
The aim of this study is to compare surgical results of colonic resection performed by single port and multiport laparoscopic approaches. Primary endpoint is the length of postoperative hospital stay. Secondary endpoints include postoperative mortality, postoperative morbidity, conversion rates, postoperative recovery, aesthetic results, postoperative pain, and costs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis
- •Informed consent signed
- •Social Insurance
排除标准
- •Digestive stoma in place or planned during the intervention
- •Body mass index > 30 kg/m2
- •History of previous laparotomy, except Mc Burney, Pfannenstiel ou subcostal
- •Subtotal colectomy
- •Transverse colectomy
- •Proctectomy or total coloproctectomy
- •Synchronous metastasis
- •Preoperative suspicion of T4 colorectal cancer
- •Emergency procedure
- •Associated resection (except appendectomy or liver biopsy)
- •Pregnancy or current breast feeding.
研究组 & 干预措施
1: Single port surgery
Surgery with single port
干预措施: single port surgery (Procedure)
1: Single port surgery
Surgery with single port
干预措施: Multiport surgery (Procedure)
2: Multiport surgery
Surgery with multiport
干预措施: Multiport surgery (Procedure)
结局指标
主要结局
Length of postoperative hospital stay
时间窗: 30 days
Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge
次要结局
- Post-operative morbidity(Day 30)
- Postoperative pain(6 days)
- Pathologic results(Day 180)
- Costs(Day 180)
- Lenght of true hospitalization stay(30 days)
- Postoperative recovery(30 days)
- Aesthetic results(180 days)
- Operative mortality(30 days)
- Conversion rates(Day 1)
- Technical feasability(Day 1)
- Post-operative quality of life(Day 180)