Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-31 @ 9:29 AM
Study NCT ID:
NCT07148895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Post-operative Outcomes After Children's Sistrunk Procedure With or Without a Drain
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multi-Center Trial Assessing Post-Operative Outcomes Following Pediatric Sistrunk Procedures With or Without Drain Placement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose of the Study:
This study looks at how kids recover after a type of neck surgery called the Sistrunk procedure. Some kids have a small tube (called a drain) placed during surgery, and some do not. The goal is to see if using a drain makes a difference in how well they heal.
Who Is in the Study:
Children who are having surgery to remove a thyroglossal duct cyst-a common lump in the neck that some kids are born with.
Main Questions the Study Wants to Answer:
Does using a drain lower the chance of problems at the surgery site? Does using a drain change how often kids need more treatment or have to go back to the hospital?
What Will Happen:
Kids will have the Sistrunk surgery, with or without a drain. Doctors will watch how they heal and check for any problems, like infections, needing more procedures, or going back to the hospital.
This study looks at how kids recover after a type of neck surgery called the Sistrunk procedure. Some kids have a small tube (called a drain) placed during surgery, and some do not. The goal is to see if using a drain makes a difference in how well they heal.
Who Is in the Study:
Children who are having surgery to remove a thyroglossal duct cyst-a common lump in the neck that some kids are born with.
Main Questions the Study Wants to Answer:
Does using a drain lower the chance of problems at the surgery site? Does using a drain change how often kids need more treatment or have to go back to the hospital?
What Will Happen:
Kids will have the Sistrunk surgery, with or without a drain. Doctors will watch how they heal and check for any problems, like infections, needing more procedures, or going back to the hospital.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: