MedTrace Logo

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

NCT07300865 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

  • Gastrostomy Complications
  • Gastrostomy Size
  • Food Intolerance
  • Granuloma

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

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Uppsala University Hospital

    collaborator OTHER

  • Therese Hössjer

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2030-01-01
Completion
2030-01-01
FDA Device
Yes

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300865 on ClinicalTrials.gov