NCT02665026 - 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)

Dindo D, Demartines N, Clavien PA
Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13.
Matthiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R
Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14.
Tulchinsky H, Shacham-Shmueli E, Klausner JM, Inbar M, Geva R
Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? J Surg Oncol. 2014 Mar;109(3):266-9. doi: 10.1002/jso.23493. Epub 2013 Nov 19.

A Single Center, Open, Randomized Clinical Trials, Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Total Mesorectal Excision for Middle and Low Rectal Cancer

Details for clinical trial NCT02665026

Clinical trial NCT02665026 - References