The 'SILVERMAN1' Trial Single Incision Laparoscopic Versus Existing Resection (Minimal Access) for Neoplasia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- operative time
研究概览
简要总结
Current evidence regarding the optimal surgical approach to potentially curable right colonic cancer is based on numerous, well designed randomised controlled clinical trials. Currently, eminence based opinion suggests that an alternative surgical technique, single incision laparoscopic surgery (SILS), may improve short and long term outcomes after minimally invasive right colonic resection. A true, prospective analysis comparing standard of care (laparoscopic right hemicolectomy) and this "new" therapy(SILS) has yet to be published. Having established the optimum treatment modality the minimally invasive approach to right colonic tumors the results will be communicated at national and international meetings.
详细描述
The 'SILVERMAN' 1 Trial Single Incision Laparoscopic Versus Existing Resection (Minimal Access) for Neoplasia- A Multi-institutional Randomised Controlled Trial
Applicant:
Professor Desmond C Winter, Institute for Clinical Outcomes Research and Education (iCORE), St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland.
Background Colonic cancer is the third commonest cause of cancer mortality in women and men in the developed world[1]. Old age, adenomatous colorectal polyps, inflammatory bowel disease, low intake of dietary fibre and family history of colorectal cancer all predispose to the development of colonic cancer[2-4]. Certain genetic syndromes such as Hereditary Non-Polyposis Colon Cancer (HNPCC), Familial Adenomatous Polyposis (FAP), Peutz-Jeghers Syndrome (PJS) and Juvenile Polyposis have a significant lifetime risk of developing colonic cancer[5-8]. Historically, open surgery has been the mainstay of treatment for localised, potentially curable colonic cancer. Laterally, minimally invasive or laparoscopic surgery has largely supplanted open surgery in the management of colonic cancer[9,10,11]. Published data have shown that laparoscopic assisted resection has equivalent oncological outcomes in terms of long term survival when compared to conventional open surgery. Similarly, Level 1 evidence from the major randomised controlled trials in this field suggests that laparoscopic colonic resection confers advantages over the open approach during the perioperative period in terms of reduced requirement for parenteral narcotics and oral analgesics, earlier restoration of intestinal function, earlier ambulation, and shorter hospital stay. To date there remains no consensus or accepted guidelines on the surgical management of potentially curable right colonic cancer. The NHS published guidelines on management of colorectal cancer simply state that surgeons offering their patients potentially curative laparoscopic resections should be appropriately trained in such specialist techniques12. Currently, surgeons competent in minimal access surgery favour laparoscopic right hemicolectomy as the technique of choice for right colonic resection. Intestinal continuity can be restored intracorporeally, or extracorporeally by exteriorising the mobilised segment of ileum/right and transverse colon.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •Histologic confirmation of right colonic cancer
- •Informed consent
排除标准
- •Inability to give informed consent (e.g. dementia)
- •Previous midline laparotomy incision
- •T4 tumour diagnosed on pre-operative imaging or intra-operatively
- •Previous pelvic irradiation
- •Colonic carcinoma against a background of ulcerative colitis.
- •Emergent surgery for perforated/obstructing right colonic cancer
结局指标
主要结局
operative time
时间窗: Within 3 months of surgery
The length of time taken to complete each procedure will be recorded
pain scores (visual analog scale)
时间窗: Within 90 days of surgery
Pain scores will be calculated on day 1,2 and 3 post-operatively and on first clinic visit
cosmesis satisfaction
时间窗: within 1 year of surgery
Peri-operative complications will be recorded within 3 months of the index operation
时间窗: within 3 months of surgery
early morbidity- wound/respiratory / urinary sepsis, thromboembolic, cardiorespiratory, anastomotic leak, intra-abdominal abscess, reoperation
Intravenous narcotic/ oral analgesic requirements
时间窗: Within 3 months of surgery
Patients analgesic requirements will be calculated both in-hospital and after discharge records will be detailed at clinic visit
Resumption of intestinal function/ diet - Duration to discharge home - Return to normal activity
时间窗: within 3 months of surgery
Time to passage of flatus, bowel motion and dietary intake will be recorded while the patient is in hospital
Duration to discharge home
时间窗: within 3 months of date of surgery
Time patient is in hospital will be recorded on discharge from the unit
Return to normal activity/work
时间窗: within 6 months of surgery
The timeframe from surgery to resumption of normal activities of daily living and return to work will be determined at patients second clinic visit
次要结局
- Lymph node yield(within 3 months of surgery)
- Conversion rate(Within 3 months of surgery)
- 30 day mortality(within 3 months of surgery)
- Cancer free survival(5 years following the date of surgery)