Right Colon Tumors Clinical Trial
— SILVERMAN 1Official title:
The 'SILVERMAN1' Trial Single Incision Laparoscopic Versus Existing Resection (Minimal Access) for Neoplasia
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | July 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-85 years 2. Histologic confirmation of right colonic cancer 3. Informed consent Exclusion Criteria: 1. Inability to give informed consent (e.g. dementia) 2. Previous midline laparotomy incision 3. T4 tumour diagnosed on pre-operative imaging or intra-operatively 4. Previous pelvic irradiation 5. FAP/ HNPCC 6. Colonic carcinoma against a background of ulcerative colitis. 7. Emergent surgery for perforated/obstructing right colonic cancer 8. Pregnancy |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Ireland | St. Vincent's University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Irish Clinical Outcomes in Research and Education | The Cleveland Clinic |
Ireland,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | operative time | The length of time taken to complete each procedure will be recorded | Within 3 months of surgery | No |
Primary | pain scores (visual analog scale) | Pain scores will be calculated on day 1,2 and 3 post-operatively and on first clinic visit | Within 90 days of surgery | No |
Primary | cosmesis satisfaction | within 1 year of surgery | No | |
Primary | Peri-operative complications will be recorded within 3 months of the index operation | early morbidity- wound/respiratory / urinary sepsis, thromboembolic, cardiorespiratory, anastomotic leak, intra-abdominal abscess, reoperation | within 3 months of surgery | No |
Primary | Intravenous narcotic/ oral analgesic requirements | Patients analgesic requirements will be calculated both in-hospital and after discharge records will be detailed at clinic visit | Within 3 months of surgery | No |
Primary | Resumption of intestinal function/ diet - Duration to discharge home - Return to normal activity | Time to passage of flatus, bowel motion and dietary intake will be recorded while the patient is in hospital | within 3 months of surgery | No |
Primary | Duration to discharge home | Time patient is in hospital will be recorded on discharge from the unit | within 3 months of date of surgery | No |
Primary | Return to normal activity/work | The timeframe from surgery to resumption of normal activities of daily living and return to work will be determined at patients second clinic visit | within 6 months of surgery | No |
Secondary | Lymph node yield | The pathology specimen detailing the lymph node count will be entered at first clinic visit post-operatively or within 3 months of surgery | within 3 months of surgery | No |
Secondary | Conversion rate | The conversion from a laparoscopic to an open procedure will be known at time of operation and will be recorded prior to patient discharge or at the first clinic visit | Within 3 months of surgery | No |
Secondary | 30 day mortality | Mortality rates within 30 days will be recorded during the hospitl stay or within 3 months of surgery | within 3 months of surgery | Yes |
Secondary | Cancer free survival | Cancer free survival will be determined at 5 years from the index surgery. Expected 5 years, disease free survival should be equivalent if the hypothesis is true. | 5 years following the date of surgery | Yes |