Randomized Controlled Trial of Percutaneous Radiologic Gastrostomy Performed With and Without Gastropexy: Technical Success, Patient-Reported Outcomes and Safety

Purpose The aim of this study is to compare balloon-retention percutaneous radiologic gastrostomy (PRG) tube insertion performed with and without gastropexy, primarily focusing on pain and patient-reported outcomes. Materials and Methods Research ethics board approved a dual-arm, single-centre, rand...

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Veröffentlicht in:Cardiovascular and interventional radiology 2021-07, Vol.44 (7), p.1081-1088
Hauptverfasser: Patel, Neeral R., Bailey, Shawn, Tai, Elizabeth, Mirrahimi, Arash, Mafeld, Sebastian, Beecroft, J. Robert, Tan, Kong Teng, Annamalai, Ganesan
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Sprache:eng
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Zusammenfassung:Purpose The aim of this study is to compare balloon-retention percutaneous radiologic gastrostomy (PRG) tube insertion performed with and without gastropexy, primarily focusing on pain and patient-reported outcomes. Materials and Methods Research ethics board approved a dual-arm, single-centre, randomized trial of 60 patients undergoing primary 14-French PRG tube insertion (NCT04107974). Patients were randomized to receive either PRG with gastropexy or without gastropexy. Data were collected for technical outcomes, patient-reported outcomes pre-procedure, post-procedure and at 1-month, as well as quality of life parameters at 1-month post-procedure (EQ5D-5L, Visual Analogue Scale and Functional Assessment of Cancer Therapy-Enteral Feeding questionnaires). Complications occurring up to 6-months post-procedure were recorded. Results Sixty patients were randomized to the gastropexy group (n = 30) or non-gastropexy (n = 30) group. One non-gastropexy patient was withdrawn from the study due to failed insertion. PRG procedural time was significantly longer when using gastropexy (mean 11.4 ± 7.19 min) compared with non-gastropexy (mean 6.79 ± 4.63 min; p 
ISSN:0174-1551
1432-086X
DOI:10.1007/s00270-021-02806-4