NCT04397627 - 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)

Aloia TA, Zimmitti G, Conrad C, Gottumukalla V, Kopetz S, Vauthey JN
Return to intended oncologic treatment (RIOT): a novel metric for evaluating the quality of oncosurgical therapy for malignancy. J Surg Oncol. 2014 Aug;110(2):107-14. doi: 10.1002/jso.23626. Epub 2014 May 21.
Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H
Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. Epub 2005 Apr 21. Review.
Italian ColoRectal Anastomotic Leakage (iCral) Study Group
Anastomotic leakage after elective colorectal surgery: a prospective multicentre observational study on use of the Dutch leakage score, serum procalcitonin and serum C-reactive protein for diagnosis. BJS Open. 2020 Mar 5. doi: 10.1002/bjs5.50269. [Epub ahead of print]
Kehlet H
Fast-track colorectal surgery. Lancet. 2008 Mar 8;371(9615):791-3. doi: 10.1016/S0140-6736(08)60357-8. Review.

Enhanced Recovery Pathways, Patient-reported Outcomes and Return to Intended Oncological Therapy After Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 3).

Details for clinical trial NCT04397627

Clinical trial NCT04397627 - References