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A randomized trial of polyurethane and silicone percutaneous endoscopic gastrostomy catheters
S J Van Den Hazel1, C J Mulder, G Den Hartog
1Department of Gastroenterology, Rijnstate Hospital, Arnhem, the Netherlands.
Insights
Polyurethane percutaneous endoscopic gastrostomy (PEG) catheters showed fewer short-term complications than silicone PEGs. However, major complications and long-term functionality were similar between the two types of PEG tubes.
Area of Science:
- Gastroenterology
- Medical Devices
- Surgical Technology
Background:
- Limited data exist comparing polyurethane and silicone percutaneous endoscopic gastrostomy (PEG) catheters regarding complication rates and long-term performance.
- Percutaneous endoscopic gastrostomy (PEG) is a common procedure for enteral nutrition support.
Purpose of the Study:
- To compare the complication rates and long-term functioning of polyurethane versus silicone PEG catheters.
- To evaluate the safety and efficacy of different PEG catheter materials.
Main Methods:
- A randomized trial involving 106 patients undergoing PEG placement, assigned to either polyurethane or silicone catheters.
- Prospective monitoring for 28 days post-placement for complications, with retrospective data collection for long-term PEG survival.
- Analysis of major and overall complications, PEG malfunctioning, and complication-free survival duration.
Main Results:
- Polyurethane PEGs were associated with fewer overall short-term complications (4 vs. 17), but major complications were similar (2 vs. 2) within the first four weeks.
- Long-term follow-up in 96 patients revealed comparable rates of PEG removal due to malfunctioning (7 polyurethane vs. 10 silicone).
- Median complication-free survival was 916 days for polyurethane and 354 days for silicone, though this difference was not statistically significant (P=0.24).
Conclusions:
- Polyurethane PEG catheters demonstrated a lower incidence of short-term complications compared to silicone catheters.
- Despite short-term differences, major complications and long-term functional outcomes were comparable between polyurethane and silicone PEG devices.
- The study suggests that while polyurethane may offer an advantage in early complication reduction, both materials provide similar long-term performance.
Background:
No data are available on differences in complication rate and long-term functioning between polyurethane and silicone percutaneous endoscopic gastrostomy (PEG) catheters.
Methods:
We randomized patients who qualified for PEG placement to receive either a polyurethane or silicone PEG catheter. Patients were prospectively monitored for 28 days after placement for the occurrence of complications. Data on long-term PEG survival were obtained retrospectively from the Hospital and general practitioner's medical records.
Results:
One hundred and six patients were randomized (polyurethane 50, silicone 56). During the first four weeks of follow-up, major complications occurred twice with both polyurethane and silicone PEGs (relative risk 1.1, 95% confidence interval: 0.11-11). Overall complications occurred four times with polyurethane and 17 times with silicone PEGs (relative risk 3.8, 95% confidence interval: 1.37-10.5). Long-term follow-up was available in 96 patients. Seven polyurethane PEGs and 10 silicone PEGs were removed because of PEG malfunctioning, the remainder functioned well until death or the reinstitution of oral feeding. The median complication-free survival was 916 days for the polyurethane PEG and 354 days for the silicone PEG (Log rank test: P=0.24).
Conclusion:
Polyurethane PEG catheters were associated with less short-term complications than silicone catheters, but major complications and long-term function were comparable.