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RECRUITING
NCT07300865
NA

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

Sponsor: Therese Hössjer

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 15 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-11-20

Completion Date

2030-01-01

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

DEVICE

12 Fr gastrostomy tube/button

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

DEVICE

14 Fr gastrostomy tube/button

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

Locations (1)

Barnkirurgi/Pediatric surgery

Uppsala, Sweden