Randomized Trial of Intra-Corporeal Anastomosis for RighT Colectomies (RICART Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Return of bowel function
研究概览
简要总结
Adult patients who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.
详细描述
The purpose of this trial is to investigate whether minimally invasive right colectomies done with an intra-corporeal anastomosis result in quicker return of bowel function and earlier discharge. The primary endpoint of this study will be return of bowel function as measured by passage of flatus and bowel motions. The secondary endpoints will be inpatient length of stay, incision length, postoperative narcotic use, surgical site infection (superficial, deep and organ-space), perioperative morbidity and operating room charges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
The patients, nursing staff and the perioperative care team (physician assistants, residents) will be blinded.
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
- •Eligible patients are those over 18 years of age who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis. Right colectomy will be defined as removal of the ascending colon, ligation of the ileocolic artery and vein, +/- removal of the terminal ileum, +/- removal of the proximal transverse colon, and +/- removal of the right branch of the middle colic artery and vein.
排除标准
- •Pregnant women
- •Additional colon resection is planned (i.e. left colectomy or proctectomy)
- •Vulnerable populations such as prisoners or adults unable to give consent
- •If the scheduled surgery is planned at Butterworth hospital (as to standardize the nursing care received postoperatively)
- •Emergent cases
- •Patients will be excluded from the study intra-operatively if:
- •The procedure is converted to an open resection
- •If a loop ileostomy is performed in addition to the right colectomy
研究组 & 干预措施
Intra-corporeal
Right Hemicolectomy
干预措施: Right Hemicolectomy (Procedure)
Extra-corporeal
Right Hemicolectomy
干预措施: Right Hemicolectomy (Procedure)
结局指标
主要结局
Return of bowel function
时间窗: up to 2 weeks
Flatus and bowel motions
次要结局
- Inpatient length of stay(up to 2 weeks)
- Postoperative narcotic use(up to 2 weeks)
- Surgical site infection(up to 6 weeks)
- Incision length(Surgery date)
- Perioperative morbidity(Baseline (Prior to surgery))
- Operating room charges(Surgery date)
研究者
James W. Ogilvie
Colorectal Surgeon
Corewell Health West