NCT02728427 - 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)

Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group
A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.
Bouchet-Doumenq C, Lefevre JH, Bennis M, Chafai N, Tiret E, Parc Y
Management of postoperative bladder emptying after proctectomy in men for rectal cancer. A retrospective study of 190 consecutive patients. Int J Colorectal Dis. 2016 Mar;31(3):511-8. doi: 10.1007/s00384-015-2471-8. Epub 2015 Dec 22.
Jayne DG, Brown JM, Thorpe H, Walker J, Quirke P, Guillou PJ
Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg. 2005 Sep;92(9):1124-32.
Maurer CA, Z'Graggen K, Renzulli P, Schilling MK, Netzer P, Büchler MW
Total mesorectal excision preserves male genital function compared with conventional rectal cancer surgery. Br J Surg. 2001 Nov;88(11):1501-5.
Perrin LC, Penfold C, McLeish A
A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery. Aust N Z J Surg. 1997 Aug;67(8):554-6.
Ratnaval CD, Renwick P, Farouk R, Monson JR, Lee PW
Suprapubic versus transurethral catheterisation of males undergoing pelvic colorectal surgery. Int J Colorectal Dis. 1996;11(4):177-9.
Sethia KK, Selkon JB, Berry AR, Turner CM, Kettlewell MG, Gough MH
Prospective randomized controlled trial of urethral versus suprapubic catheterization. Br J Surg. 1987 Jul;74(7):624-5.

Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer

Details for clinical trial NCT02728427

Clinical trial NCT02728427 - References