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

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

Inclusion Criteria1

  • Scheduled for laparoscopic gastrostomy at Dep Pediatric Surgery Uppsala Akademiska University Hospital

Exclusion Criteria1

  • 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)

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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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