RecruitingNot ApplicableNCT07300865

Does the Thickness of the Gastrostomy Affect the Incidence of Complications? A Prospective Randomized Single-Center Study in Children

Sponsor

Therese Hössjer

Enrollment

200 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Food Intolerance Gastrostomy Complications Granuloma Gastrostomy Size

Summary

The goal of this interventional study is to compare two different sizes of a gastrostomy tube in children and the incidence of complications three months postoperatively. The study is questionnare-based and both the family and health care personel will fill in the formula about complications at the re-visit when the tube is changed the first time at three months postoperatively. Complications requested are: granuloma, infection, pain, dislocation and leakage.

Eligibility

Max Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 12 Fr gastrostomy tube/button and a medical device called 14 Fr gastrostomy tube/button for people with food intolerance, gastrostomy complications, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include up to age 15 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE12 Fr gastrostomy tube/button

Patients in this arm will recieve 12 Fr size gastrostomy tube/ button

DEVICE14 Fr gastrostomy tube/button

Patients in this arm will recieve 14 Fr size gastrostomy tube/ button

Locations(1)

Barnkirurgi/Pediatric surgery

Uppsala, Sweden

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NCT07300865

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