NCT06044116 - 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. doi: 10.1097/01.sla.0000133083.54934.ae.
Poelemeijer YQM, Marang-van de Mheen PJ, Wouters MWJM, Nienhuijs SW, Liem RSL
Textbook Outcome: an Ordered Composite Measure for Quality of Bariatric Surgery. Obes Surg. 2019 Apr;29(4):1287-1294. doi: 10.1007/s11695-018-03642-1.

Design and Validation of a Preoperative Calculator for "Textbook Outcome" After Bariatric Surgery: Project BARCINO (BARiatric Surgery Calculator Nomogram for Textbook Outcome)

Details for clinical trial NCT06044116

Clinical trial NCT06044116 - References