NCT06193837 - 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)

Kim HJ, Kang SH, Roh YH, Kim MC, Kim KW
Are prophylactic antibiotics necessary in elective laparoscopic cholecystectomy, regardless of patient risk? Ann Surg Treat Res. 2017 Aug;93(2):76-81. doi: 10.4174/astr.2017.93.2.76. Epub 2017 Jul 28.
Yan RC, Shen SQ, Chen ZB, Lin FS, Riley J
The role of prophylactic antibiotics in laparoscopic cholecystectomy in preventing postoperative infection: a meta-analysis. J Laparoendosc Adv Surg Tech A. 2011 May;21(4):301-6. doi: 10.1089/lap.2010.0436. Epub 2011 Mar 28.

Prophylactic Antibiotic in Non-complicated Low Risk Laparoscopic Cholecystectomy; Is it Worthy? A Prospective Randomized Comparative Study.

Clinical trial NCT06193837 - References