About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for laparoscopic gastrostomy at Dep Pediatric Surgery Uppsala Akademiska University Hospital
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
12 Fr gastrostomy tube/button
DevicePatients in this arm will recieve 12 Fr size gastrostomy tube/ button
14 Fr gastrostomy tube/button
DevicePatients in this arm will recieve 14 Fr size gastrostomy tube/ button
Treatment groups
Trial outcomes
Primary outcomes
Granuloma
Infection
Observed pain by caretakers/health care personel
Dislocation
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Therese Hössjer
Lead sponsor
Uppsala University Hospital
Sponsor institution
Uppsala University
Collaborator
Uppsala University Hospital
Collaborator