RObotic Vs LAparoscopic Colectomy for DIverticulitis. a Multicenter Observational Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,450
- 试验地点
- 1
- 主要终点
- Conversion rate
研究概览
简要总结
Over the last decade there has been a growing interest toward the application of robotic approach for diverticular disease. The evidence available on the literature showed that robotic approach, compared to the laparoscopic surgery, offers significant advantages in terms of conversion rate and shortened hospital stay for the treatment of diverticular disease.
The investigators aimed at evaluating whether robotic colectomy may offer some advantages over the laparoscopic approach for surgical treatment of diverticular disease by analyzing a one year multicenter prospective study.
Primary objective is to evaluate if robotic approach reduce the rate of conversion to open approach compared to laparoscopic surgery. Secondary objective is to assess difference between the two approaches in terms of rate of intraoperative complication, postoperative morbidities (according with Clavien and Dindo Classification), hospital stay and at one year follow up. Inclusion criteria are: elective colectomy for complicated or non-complicated diverticular disease performed with laparoscopic or robotic approach and age between 18 and 90 years. Exclusion criteria are non-elective colectomy (emergency resection), open procedure, diverticular resection performed during other procedure (i.e. colectomy for cancer). Data will be collected in one year from the start of the study.
Due to the lack of available evidence, it is impossible to draw definitive conclusions. With this study, the investigators hope to clarify the role of the robotic approach in the treatment of diverticular disease.
详细描述
Background Over the past decade, there has been a growing interest in the use of robotic surgery for diverticular disease (DD). The evidence available in the literature is based on retrospective studies and two meta-analyses1,2. To date, the robotic approach offers significant advantages over laparoscopic surgery in terms of conversion rate and shortened hospital stay for the treatment of diverticular disease.
The investigators aimed to evaluate whether elective robotic colectomy may offer some advantages over the laparoscopic approach for surgical treatment of diverticular disease performing a prospective multicenter study.
Methods and Materials This is a multi-center, prospective, not-for-profit cohort study that will enroll patients undergoing elective or delayed urgent surgical treatment for left-sided colonic diverticular disease. The enrollment period will be one year, followed by one year of follow-up. The study will start in Juin 2023.
Data will be collected in a prospective database using an easy to fill out Google form, also available on mobile devices.
Several preoperative, intraoperative and postoperative outcomes will be analyzed.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Elective or delayed urgency colorectal resection for left-sided DD
- •Fully minimally invasive (robotic or laparoscopic) procedures.
排除标准
- •Age < 18 years
- •Urgent resection for DD
- •Hybrid minimally invasive resection
- •Conventional open resection.
结局指标
主要结局
Conversion rate
时间窗: One year
The primary objective is to evaluate whether the robotic approach reduces the rate of conversion to open surgery compared to laparoscopic surgery.
次要结局
- Operative time(One year)
- 30-day Post - operative re-operation(One year)
- Time to return at work(One year)
- Complicated disease(One year)
- Intra - operative complications(One year)
- 30 day Post - operative complications(One year)
- Length of hospital stay(One year)
- One year follow up(Two years)
- 30-day Post - operative mortality(One year)
研究者
Giuliani Giuseppe
MD - Assistant surgeon
S.M. Misericordia Hospital