NCT05348473 - 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)

Ferrer-Márquez M, Espínola-Cortés N, Reina-Duarte Á, Granero-Molina J, Fernández-Sola C, Hernández-Padilla JM
Analysis and description of disease-specific quality of life in patients with anal fistula. Cir Esp (Engl Ed). 2018 Apr;96(4):213-220. doi: 10.1016/j.ciresp.2017.12.003. Epub 2018 Feb 13. English, Spanish.
Ferrer-Márquez M, Espínola-Cortés N, Reina-Duarte A, Granero-Molina J, Fernández-Sola C, Hernández-Padilla JM
Design and Psychometric Evaluation of the Quality of Life in Patients With Anal Fistula Questionnaire. Dis Colon Rectum. 2017 Oct;60(10):1083-1091. doi: 10.1097/DCR.0000000000000877.
Kristo I, Stift A, Staud C, Kainz A, Bachleitner-Hofmann T, Chitsabesan P, Riss S
The type of loose seton for complex anal fistula is essential to improve perianal comfort and quality of life. Colorectal Dis. 2016 Jun;18(6):O194-8. doi: 10.1111/codi.13335.

Comparison of the Effects of Different Seton Application Techniques on the Quality of Life in the Postoperative Period in Perianal Fistula Disease

Clinical trial NCT05348473 - References