Gastrostomy tube thickness: 12 Fr versus 14 Fr in children
Official title: Does the Thickness of the Gastrostomy Affect the Incidence of Complications? A Prospective Randomized Single-Center Study in Children
Run by Uppsala University Hospital · NCT07300865 · Data updated 2026-11-12
This test will compare whether a thinner 12 Fr or a thicker 14 Fr gastrostomy tube leads to fewer complications in children having a laparoscopic gastrostomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 15 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Uppsala University Hospital Academic / other |
| Locations | 1 site (Uppsala) |
| Status | Recruiting |
| Started | November 20, 2025 |
| Main results expected | January 1, 2030 |
| Study ends | January 1, 2030 |
| Registry record updated | December 24, 2025 |
| Trial ID | NCT07300865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children scheduled for laparoscopic gastrostomy at Uppsala Akademiska University Hospital who have no medical reason to require a specific tube size are eligible.
✕Probably not a fit
Children who must receive a particular tube size because of mixed feeding, medications that risk clogging, or other specific clinical reasons are unlikely to benefit from randomization.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, single-center comparison of two gastrostomy tube sizes placed by laparoscopic technique in children. Families and healthcare personnel will complete questionnaires about complications at the first tube change, three months after surgery. The study will record granuloma, infection, pain, tube dislocation and leakage as predefined outcomes. Children with a clinical reason to require a specific tube size (for example to handle mixed foods or medications that might clog a smaller tube) are excluded.
Why it matters
Potential benefit: If the smaller tube reduces complications, children could experience fewer wound problems and easier everyday feeding after gastrostomy.
How similar studies have gone: There is limited randomized evidence directly comparing 12 Fr and 14 Fr gastrostomy tubes in children, so this comparison is relatively novel and pragmatic.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for laparoscopic gastrostomy at Dep Pediatric Surgery Uppsala Akademiska University Hospital Exclusion Criteria: * Any specific reasons to avoid one size or the other (children who are supposed to get mixed food or a special medication that can obstruate the tube will recieve a thicker tube)
Where it's running
-
Barnkirurgi/Pediatric surgery
Uppsala, Sweden Recruiting
Study contacts
- Study coordinator: Therese NL Hössjer, MD, PhD-student
- Email: therese.hossjer@uu.se
- Phone: +4618674613
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.