Other Clinical Trial - Retrospective/Prospective Study of Pediatric

Clinical Trial Summary

UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients. At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report. Since it is a surgical and therapeutic first it needs to be aon regestiry of health research prior to publication.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

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.

NCT number	NCT04899557
Study type	Observational
Source	University of Illinois at Chicago
Contact
Status	Completed
Phase
Start date	April 27, 2021
Completion date	May 1, 2021

Retrospective/Prospective Study of Pediatric Surgical Patients

Clinical Trial Summary

Clinical Trial Description

Study Design