NCT03215017 - 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)

Pieniowski EHA, Bergstrom CM, Nordenvall CAM, Westberg KS, Johar AM, Tumlin Ekelund SF, Larsson KR, Pekkari KJ, Jansson Palmer GC, Lagergren P, Abraham-Nordling M
A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery. Ann Surg. 2023 Jan 1;277(1):30-37. doi: 10.1097/SLA.0000000000005482. Epub 2022 Jul 7.

A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery

Clinical trial NCT03215017 - References