A Controlled Randomized Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Postoperative morbidity
研究概览
简要总结
The aim of this study is to better understand whether robotic surgery leads to better outcomes than laparoscopy in terms of complications, recovery and quality of life.
详细描述
This clinical trial compares two surgical techniques, robotic surgery and conventional laparoscopic surgery, for patients with inflammatory bowel disease (IBD) requiring elective colorectal surgery. Both approaches are minimally invasive and commonly used in clinical practice. This is a randomized trial: participants will be randomly assigned to one of the two techniques. A total of 110 patients will be enrolled.
This study will evaluate the role of robotic surgery in the surgical treatment of inflammatory bowel disease.
Three quality-of-life questionnaires will be completed: before the procedure and at 30 and 90 days post-procedure. Pain will also be assessed during the first three days post-procedure using a specific score called the VAS.
This study will be conducted exclusively at the University Hospitals Leuven.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- •Diagnosed with IBD and eligible for elective minimally invasive colorectal surgery, including:
- •1.4 Ileocecal/ileocolic resections 1.5 Segmental colectomies 1.6 Total colectomy 1.7 Proctocolectomy 1.8 Proctectomy
- •Procedures involving primary anastomosis or temporary or permanent stoma creation
- •Suitable for minimally invasive surgery
排除标准
- •Non IBD patients
- •Urgent surgery (<24 hours from hospital admission)
- •Not suitable for minimally invasive surgery
- •Ileoanal pouch construction
结局指标
主要结局
Postoperative morbidity
时间窗: During the first 90 days postoperatively
Assessed using the Comprehensive Complication Index (CCI)
次要结局
- Conversion to open surgery(Surgery day)
- 2. Postoperative pain(First three postoperative days)
- Costs(Till 90 days postoperatively)
- Quality of life (QoL)(At 30 and 90 days postoperatively)