Single Incision Laparoscopic Right Hemi-colectomy Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Successful completion of the right hemicolectomy
研究概览
简要总结
The investigators will document the success for completing laparoscopic resection of cancer in the right colon using a new single port access technique. The current procedure requires 4 incisions for 4 separate ports. With technological advancement of newly designed instruments it is now possible to do the same laparoscopic procedure through a single port. The investigators want to demonstrate here in British Columbia that it is a safe procedure with similar success and outcomes compared to the standard 4-port laparoscopic operation.
The investigators propose that this procedure may provide early discharge due to less pain and also be associated with less wound infection and hernia complications. The single incision will have improved cosmesis compared to the standard 4-port standard laparoscopic procedure.
详细描述
Purpose:
The purpose of the study is to demonstrate that single port right hemi-colectomy can be performed with consistency. The second purpose is to assess single port surgery in terms of length of stay in the hospital, analgesics requirement, and length of scar at 30 days. The single port surgery is a latest advancement towards achieving minimal scarring after major abdominal surgery.
Justification:
Laparoscopic Colon resection is well-documented and standard practice in many centers throughout the world. A Cochrane Review of 25 Randomized Control Trials (RCT) published in 2005 looked at the short term (30 Days) benefits of laparoscopic colorectal resection showed better outcome in intra-operative blood loss, intensity of postoperative pain, postoperative hospital stay, duration of postoperative ileus, and pulmonary functions (1). Total morbidity and local (surgical) morbidity was decreased in the laparoscopic groups. Until the 30th postoperative day, quality of life was better in laparoscopic patients. They concluded if the long-term oncological results of laparoscopic and conventional resection of colonic carcinoma show equivalent results, the laparoscopic approach should be preferred in patients suitable for this approach to colectomy. A Cochrane Review published in 2008 looked at 33 RCT's comparing laparoscopic/Laparoscopic-assisted and open colectomy for colo-rectal carcinoma found similar long-term oncologic outcomes in both groups (2).
Single Incision Laparoscopic Surgery (SILS) instead of traditional 4 ports theoretically may reduce the wound complications. For cholecystectomy, a blinded randomized control study showed significant reduction in pain control at sub-costal port-sites in 2-port versus 4-port laparoscopic cholecystectomy and also showed similar pain at umbilical port (3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 age 19 years or older diagnosed with resectable right colon cancer
排除标准
- •Advanced cancer on routine preoperative CT (local invasion, distant metastases)
- •maximum diameter of cancer > 5cm
- •previous abdominal surgery
- •emergency surgery
- •pregnancy
- •ages < 18 years old
- •ASA (American Society of Anesthesiologists) Class III or above
- •Any other contraindications to laparoscopic surgery
- •Non-English speaking/reading or unable to give consent
结局指标
主要结局
Successful completion of the right hemicolectomy
时间窗: 1 day
The first and main outcome is to assess if right hemicolectomy can be safely performed using the Single Port.
次要结局
- Total Length of surgical incision (cm)(30 days)
- Pathology: Resection margin clearance(15 Days)
- Total Number of Surgical Incisions(1 Day)
- 30 Day Mortality(30 Days)
- Length of postoperative hospital stay(30days)
- Postop Complications: Wound Dehiscence(30 Day)
- Postoperative complications: Requirement of Re-operation(30 Days)
- Postoperative Complications: Others(30 Day)
- Use of additional ports and reason(1 day)
- Conversion to an open procedure and reason(1 day)
- Pathological Cancer stage (TNM)(15 Days)
- Postoperative complications: Reason for reoperation(30 Days)
- Duration of surgery(1 Day)
- Operative complications(1 Day)
- Postoperative analgesia requirements (total opioid used)(30 days)
- Number of lymph nodes assessed(15 Days)
- Wound Infection(30 Days)
- 30 Day Re-admission(30 Days)
- Postoperative Measure of Pain(3 DAYS)