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

NCT07300865 | Recruiting FDA Device

• 1 other identifier: 2025-03305-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

laparoscopic gastrostomy; complications; pediatric surgery; children; granuloma

Outcome Measures

Primary Outcomes (5)

• Granuloma

  3 months postoperatively

• Infection

  3 months postoperatively

• Observed pain by caretakers/health care personel

  3 months postoperatively

• Dislocation

  3 months postoperatively

• Leakage

  3 months postoperatively

Study Arms (2)

Children recieving 12 Fr gastrostomy tube

OTHER

Device: 12 Fr gastrostomy tube/button

Children recieving 14 Fr gastrostomy tube

OTHER

Device: 14 Fr gastrostomy tube/button

Interventions

12 Fr gastrostomy tube/button DEVICE

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

Also known as: 12 Fr

Children recieving 12 Fr gastrostomy tube

14 Fr gastrostomy tube/button DEVICE

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

Also known as: 14 Fr

Children recieving 14 Fr gastrostomy tube

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Therese Hössjer: lead
• Uppsala University: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Barnkirurgi/Pediatric surgery

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Food Intolerance; Granuloma

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes

Central Study Contacts

Therese NL Hössjer, MD, PhD-student

CONTACT

+4618674613; therese.hossjer@uu.se

Johan Danielson, MD, Docent

CONTACT

+46186110000; johan.danielson@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Surgeon, PhD-student

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: December 24, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)