Prospective randomized trial comparing the direct method using a 24 Fr bumper-button-type device with the pull method for percutaneous endoscopic gastrostomy.

BACKGROUND AND STUDY AIMS: Percutaneous endoscopic gastrostomy (PEG) is the preferred route for long-term enteral feeding. The aim of this study was to compare a direct, modified introducer method using a bumper-button-type device with the standard pull method for PEG. PATIENTS AND METHODS: Between October 2005 and January 2007 consecutive patients with dysphagia were randomly assigned to PEG using either the direct method or the pull method. The direct method directly placed a 24 Fr bumper-button-type device assisted by dual gastropexy. The primary outcome measure was the rate of peristomal infections. Secondary measures included success rates, procedure times, and other complications. The long-term outcome measure was the need for catheter change within 180 days of the PEG procedure.
RESULTS: Of the 140 patients enrolled, 68 were assigned to the direct method and 72 to the pull method. There were no significant differences between the two groups with respect to clinical baseline parameters. The occurrence of peristomal infection within 30 days was significantly lower following the direct method (0 vs. 6, P = 0.028). The success rates and duration of both methods were similar (100% vs. 100%; 10.5 vs. 9.6 minutes, P = 0.48). The catheters used in the direct method required replacement significantly less often than those placed using the pull method (no catheter change in 180 days: 75% vs. 45.2%, P = 0.0019).
CONCLUSIONS: The direct method using a 24 Fr bumper-button-type device was associated with reduced peristomal infections in the early phase and reduced catheter changes compared with a 20 Fr catheter placed using the standard pull method.

RCT Entities:   Population Interventions Outcomes