NCT04713527 - 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)

Bhangu A, Søreide K, Di Saverio S, Assarsson JH, Drake FT
Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5. Review. Erratum in: Lancet. 2017 Oct 14;390(10104):1736.
Daskalakis K, Juhlin C, Påhlman L
The use of pre- or postoperative antibiotics in surgery for appendicitis: a systematic review. Scand J Surg. 2014 Mar;103(1):14-20. doi: 10.1177/1457496913497433. Epub 2013 Sep 20. Review.
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.
Kleif J, Rasmussen L, Fonnes S, Tibæk P, Daoud A, Lund H, Gögenur I
Enteral Antibiotics are Non-inferior to Intravenous Antibiotics After Complicated Appendicitis in Adults: A Retrospective Multicentre Non-inferiority Study. World J Surg. 2017 Nov;41(11):2706-2714. doi: 10.1007/s00268-017-4076-6.
National Collaborating Centre for Women's and Children's Health (UK)
Surgical Site Infection: Prevention and Treatment of Surgical Site Infection. London: RCOG Press; 2008 Oct.
Tind S, Qvist N
Acute Appendicitis: A Weak Concordance Between Perioperative Diagnosis, Pathology and Peritoneal Fluid Cultivation. World J Surg. 2017 Jan;41(1):70-74. doi: 10.1007/s00268-016-3686-8.
van Rossem CC, Schreinemacher MH, Treskes K, van Hogezand RM, van Geloven AA
Duration of antibiotic treatment after appendicectomy for acute complicated appendicitis. Br J Surg. 2014 May;101(6):715-9. doi: 10.1002/bjs.9481. Epub 2014 Mar 26.

Polymerase Chain Reaction and Cultivation of the Peritoneal Fluid at Operation for Appendicitis and Postoperative Enteral Antibiotic Treatment. A Feasibility and Non-inferiority Study

Details for clinical trial NCT04713527

Clinical trial NCT04713527 - References