Robotic Right Hemicolectomy With Intracorporeal Anastomosis Versus Laparoscopic Right Hemicolectomy With Extracorporeal Anastomosis (PRORHEM): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Time to first passage of faeces
研究概览
简要总结
Robotic right hemicolectomy with intra-corporeal anastomosis may have better short-term recovery outcomes and decreased incidence of incisional hernia when compared to the laparoscopic actual standard of care, for similar safety outcomes.
详细描述
During laparoscopic right hemicolectomy (lapRHC) for cancer or polyp, intra-corporeal anastomosis (ICA) offers better short-term recovery and decreased incidence of incisional hernia (IH) when compared to extra-corporeal anastomosis (ECA). However, because of the technical limitations of laparoscopy, ICA has not gained in wide acceptance and ECA has remained the standard of care. On the contrary, robotics offers improved suturing capacities and facilitates the realization of ICA. Therefore, robotic right hemicolectomy (robRHC) with ICA may have better short-term recovery outcomes and decreased incidence of IH when compared to the laparoscopic actual standard of care. In a randomized controlled trial, we will compare robRHC with ICA with lapRHC with ECA, in terms of recovery of bowel function (time to first passage of faeces). Secondary outcomes will notably include length of stay, incidence of IH, patient-reported esthetical outcomes and safety outcomes (morbidity, mortality, proximal and distal margins, harvested lymph nodes).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients requiring elective minimally invasive RHC for cT1-T3 Nx M0 cancer of the right colon (including cancer of the appendix, caecum, ascending colon and hepatic flexure).
排除标准
- •Not scheduled for minimally invasive RHC (refuses surgery and/or planned open approach)
- •Emergency surgery
- •Hereditary colorectal cancer
- •Inflammatory bowel disease
- •Synchronous resection of (an)other organ(s)
- •Synchronous surgical procedure (including more extended resection of the lower gastrointestinal tract)
- •History of laparotomy
- •Pregnancy
- •No anastomosis planned
- •Unable to provide informed consent
- •No informed consent
结局指标
主要结局
Time to first passage of faeces
时间窗: From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days
Measured in hours, starting at the skin closure of the index surgery
次要结局
- Distal margin(Within 10 days from the index surgical procedure)
- Quality of recovery(At post-operative hour 12, post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4, post-operative day 5 and post-operative day 7)
- Blood loss(From skin incision to skin closure, during index surgical procedure)
- Duration of surgery(From skin incision to skin closure, during index surgical procedure)
- Intra-operative transfusion(From skin incision to skin closure, during index surgical procedure)
- Intra-operative complication(From skin incision to skin closure, during index surgical procedure)
- Creation of a stoma(From skin incision to skin closure, during index surgical procedure)
- Post-operative morbidity(From index surgical procedure (skin closure) to post-operative day 30)
- Re-intervention(From index surgical procedure (skin closure) to post-operative day 30)
- Length of the extraction site(At post-operative day 30)
- Surgical site infection(From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30)
- Mortality(From index surgical procedure (skin closure) to post-operative day 30)
- Proximal margin(Within 10 days from the index surgical procedure)
- Harvested lymph nodes(Within 10 days from the index surgical procedure)
- Conversion to open surgery(From skin incision to skin closure, during index surgical procedure)
- Hb, WBC and CRP(At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5)
- Time to first passage of flatus(From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days)
- In-hospital postoperative ileus(During hospitalisation, on average during the first 5 post-operative days)
- Length of stay(From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days)
- Anastomotic leak(From index surgical procedure (skin closure) to post-operative day 30)
- Histology of the tumor/polyp(Within 10 days from the index surgical procedure)
- TNM stage(Within 10 days from the index surgical procedure)
- Bowel function(At post-operative day 30 and post-operative year 1)
- Aesthetic numeric analogue scale (ANA-scale)(At post-operative day 30 and post-operative year 1)
- Incidence of incisional hernia(At post-operative year 1)
研究者
Jeremy Meyer
Principal investigator
University Hospital, Geneva