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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 15
SponsorTherese Hössjer

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 12 Fr gastrostomy tube/button

    Device

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

  • 14 Fr gastrostomy tube/button

    Device

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Children recieving 12 Fr gastrostomy tubeOther 1 intervention
Group B: Children recieving 14 Fr gastrostomy tubeOther 1 intervention

Trial outcomes

Primary outcomes

1

Granuloma

Time frame
3 months postoperatively
2

Infection

Time frame
3 months postoperatively
3

Observed pain by caretakers/health care personel

Time frame
3 months postoperatively
4

Dislocation

Time frame
3 months postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

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Therese Hössjer

Lead sponsor

Uppsala University Hospital

Sponsor institution

Uppsala University

Collaborator

Uppsala University Hospital

Collaborator