NCT02665000 - 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)

Davis SS Jr, Husain FA, Lin E, Nandipati KC, Perez S, Sweeney JF
Resident participation in index laparoscopic general surgical cases: impact of the learning environment on surgical outcomes. J Am Coll Surg. 2013 Jan;216(1):96-104. doi: 10.1016/j.jamcollsurg.2012.08.014. Epub 2012 Sep 19. Erratum in: J Am Coll Surg. 2013 May;216(5):1034.
Gumbs AA, Hogle NJ, Fowler DL
Evaluation of resident laparoscopic performance using global operative assessment of laparoscopic skills. J Am Coll Surg. 2007 Feb;204(2):308-13. Epub 2006 Dec 27.
Kordowicz AG, Gough MJ
The challenges of implementing a simulation-based surgical training curriculum. Br J Surg. 2014 Apr;101(5):441-3. doi: 10.1002/bjs.9370. Epub 2014 Feb 26.
Papandria D, Rhee D, Ortega G, Zhang Y, Gorgy A, Makary MA, Abdullah F
Assessing trainee impact on operative time for common general surgical procedures in ACS-NSQIP. J Surg Educ. 2012 Mar-Apr;69(2):149-55. doi: 10.1016/j.jsurg.2011.08.003. Epub 2011 Oct 2.
Schell SR, Flynn TC
Web-based minimally invasive surgery training: competency assessment in PGY 1-2 surgical residents. Curr Surg. 2004 Jan-Feb;61(1):120-4.
So JB, Chiong EC, Chiong E, Cheah WK, Lomanto D, Goh P, Kum CK
Laparoscopic appendectomy for perforated appendicitis. World J Surg. 2002 Dec;26(12):1485-8. Epub 2002 Sep 26.

A Randomised Controlled Trial Evaluating the Effects of a Structured Training Program on the Learning Curve of Residents in the Field of Laparoscopic Surgery (STAR Trial)

Details for clinical trial NCT02665000

Clinical trial NCT02665000 - References