SILVERMAN Trial

The ‘SILVERMAN’ Trial: Single Incision Laparoscopic Versus Existing Resection (Minimal Access) for Neoplasia

Enrollment ended: July 02, 2015 @ 00:52:24 UTC

ClinicalTrials.gov ID: NCT01319890


Trial sponsor: iCore


Rationale:

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 a novel surgical technique, 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 a “new therapy” (SILS) has yet to be published.


Purpose:

To compare patient outcome following standard of care (laparoscopic right hemicolectomy) and a ‘new therapy’ (SILS right hemicolectomy) for the treatment of right colonic cancer. Specific research questions include:
1. Which treatment modality confers least perioperative morbidity and mortality in the surgical management of right colonic cancer?
2. Does treatment influence length of time to discharge home and return to activities of daily living?
3. Are treatment modalities equivalent in terms of extent of resection (lymph node yield, grade of resected specimen)?



Trial type: Interventional

Allocation: Randomised


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




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