NCT02117557 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bucher P, Pugin F, Morel P
Single-port access laparoscopic radical left colectomy in humans. Dis Colon Rectum. 2009 Oct;52(10):1797-801. doi: 10.1007/DCR.0b013e3181b551ce.
Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR
Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.
Hirano Y, Hattori M, Douden K, Shimizu S, Sato Y, Maeda K, Hashizume Y
Single-incision plus one port laparoscopic anterior resection for rectal cancer as a reduced port surgery. Scand J Surg. 2012;101(4):283-6.
Lim SW, Kim HJ, Kim CH, Huh JW, Kim YJ, Kim HR
Umbilical incision laparoscopic colectomy with one additional port for colorectal cancer. Tech Coloproctol. 2013 Apr;17(2):193-9. doi: 10.1007/s10151-012-0900-z. Epub 2012 Sep 19.

A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Clinical trial NCT02117557 - References