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 |
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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 One non-gastropexy patient was withdrawn from the study due to failed insertion.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 |
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ISSN: | 0174-1551 1432-086X |
DOI: | 10.1007/s00270-021-02806-4 |