Actively Recruiting
Does the Thickness of the Gastrostomy Affect the Incidence of Complications? A Prospective Randomized Single-Center Study in Children
Led by Therese Hössjer · Updated on 2025-12-24
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Therese Hössjer
Lead Sponsor
U
Uppsala University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether the thickness of gastrostomy tubes affects the rate of postoperative complications in children who need long-term enteral nutrition. This study compares two tube sizes, 12 Fr and 14 Fr, to see if a smaller tube might reduce issues such as granuloma, infection, pain, dislocation, and leakage. Gastrostomy is a common procedure in children with conditions like neurological diseases and metabolic disorders, and the study aims to provide clearer guidance on tube size choice. Children scheduled for laparoscopic gastrostomy are randomly assigned to receive either a 12 Fr or 14 Fr gastrostomy tube. After surgery, the tubes are changed at three months following national guidelines. Both families and healthcare personnel complete questionnaires about any complications experienced during this period. The data collected will be analyzed to determine if tube size influences complication rates. Participants will have a gastrostomy placed and then return for a follow-up visit three months later when the tube is changed. During this visit, questionnaires about complications such as granuloma formation, infection, pain, dislocation, and leakage will be completed by nurses and caregivers. The study will collect and analyze this information to assess outcomes. Participation involves surgery, follow-up care, and data collection over a three-month postoperative period.
CONDITIONS
Brief Title
Does the Thickness of the Gastrostomy Affect the Incidence of Complications? A Prospective Randomized Single-Center Study in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for laparoscopic gastrostomy at Dep Pediatric Surgery Uppsala Akademiska University Hospital
You will not qualify if you...
- Any specific reasons to avoid one size or the other (such as children who need mixed food or special medication that can block the tube will receive a thicker tube)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants scheduled for laparoscopic gastrostomy are assessed for eligibility.
Duration - Day of operation
Participants undergo laparoscopic gastrostomy where they receive either a 12 Fr or 14 Fr gastrostomy tube based on random assignment.
1 visit (in-person) on the day of surgery for gastrostomy tube placement and randomization.
Duration - 3 months post-operation
Participants are monitored for complications related to the gastrostomy tube such as granuloma, infection, pain, dislocation, and leakage.
1 outpatient visit for gastrostomy button change and questionnaire completion by nurse and caregivers at 3 months post-operation.
Trial Site Locations
Total: 1 location
1
Barnkirurgi/Pediatric surgery
Uppsala, Sweden, 75185
Actively Recruiting
Research Team
T
Therese NL Hössjer, MD, PhD-student
J
Johan Danielson, MD, Docent
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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