NCT03397901 - 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)

Ma TH, Yuan ZX, Zhong QH, Wang HM, Qin QY, Chen XX, Wang JP, Wang L
Formalin irrigation for hemorrhagic chronic radiation proctitis. World J Gastroenterol. 2015 Mar 28;21(12):3593-8. doi: 10.3748/wjg.v21.i12.3593.
Yuan ZX, Ma TH, Wang HM, Zhong QH, Yu XH, Qin QY, Wang JP, Wang L
Colostomy is a simple and effective procedure for severe chronic radiation proctitis. World J Gastroenterol. 2016 Jun 28;22(24):5598-608. doi: 10.3748/wjg.v22.i24.5598.

Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis With Moderate to Severe Anemia: a Prospective Cohort Study

Clinical trial NCT03397901 - References