ACTRN12620001378910已完成2 期
RoLaCaRT-1: An international randomised phase II trial comparing surgical outcomes of robotic-assisted right hemicolectomy versus laparoscopic-assisted hemicolectomy for resection of adenocarcinoma of the caecum, ascending or proximal transverse colon
Australasian Gastrointestinal Trials Group (AGITG)0 个研究点目标入组 29 人开始时间: 2020年12月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
研究概览
简要总结
we have not finished the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adults with adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon. Disease must be confirmed by histological, radiological, endoscopic diagnosis.
- •2. ECOG performance status 0-2.
- •3. Life expectancy of at least 1 year.
- •4. Surgery to be performed within 40 days of randomisation.
- •5. Elective surgery performed with curative intent.
- •6. Signed, written informed consent.
- •7. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
排除标准
- •1. Evidence of T4 disease invading adjacent organs.
- •2. Pre-operative surgical plan includes division of the middle colic vessels (extended right hemicolectomy) or any other more extensive colectomy procedure.
- •3. Synchronous surgical procedure planned with right hemicolectomy.
- •4. Urgent, unplanned or emergency surgery.
- •5. Palliative surgical intent including non-resection, stoma formation, staging laparoscopy or open and close procedures.
- •6. Prior formation of defunctioning ileostomy as part of treatment for this right colon cancer.
- •7. No plan to create a surgical ileo-colonic anastomosis.
- •8. Neoadjuvant chemotherapy administered to treat this cancer prior to resection.
- •9. Known Crohn’s disease with active terminal ileal disease.
- •10. History of any conditions that would preclude use of a minimally-invasive approach (e.g. multiple previous major laparotomies, severe adhesions, patient co-morbidity).
- •11. Concurrent or previous abdominal or pelvic malignancy within five years prior to registration irrespective of treatment modality.
- •12. Other co-morbidities or conditions that may compromise assessment of key outcomes.
- •13. Significant metastatic disease which would be expected to impact life expectancy of at least 1 year
- •14. Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation).
- •15. Pregnancy or lactation.
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