Randomized Controlled Trial of Percutaneous Radiologic Gastrostomy Performed With and Without Gastropexy: Technical Success, Patient-Reported Outcomes and Safety. 2021

Neeral R Patel, and Shawn Bailey, and Elizabeth Tai, and Arash Mirrahimi, and Sebastian Mafeld, and J Robert Beecroft, and Kong Teng Tan, and Ganesan Annamalai
Division of Interventional Radiology, Joint Department of Medical Imaging, Toronto General Hospital, University of Toronto, 585 University Ave, Toronto, ON, M5G 2N2, Canada. neeral.patel@uhn.ca.

OBJECTIVE 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. 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 One non-gastropexy patient was withdrawn from the study due to failed insertion.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 < 0.05). Pain scores did not differ between the two groups pre-procedure, post-procedure and at 1-month follow-up, nor did 1-month quality of life parameters. Six (20%) minor complications occurred in the gastropexy group and nine (31%) minor complications in the non-gastropexy group (p = 0.330). Two (6.9%) major complications occurred in the non-gastropexy group (p = 0.458). CONCLUSIONS There is comparable patient tolerability when balloon-retention PRG insertion is performed with or without gastropexy sutures. This study also demonstrated a trend towards fewer complications when gastropexy is utilized. However, further larger trials are required to compare complications of the two approaches for PRG insertion. METHODS Level 2, randomized trial.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D003680 Deglutition Disorders Difficulty in SWALLOWING which may result from neuromuscular disorder or mechanical obstruction. Dysphagia is classified into two distinct types: oropharyngeal dysphagia due to malfunction of the PHARYNX and UPPER ESOPHAGEAL SPHINCTER; and esophageal dysphagia due to malfunction of the ESOPHAGUS. Dysphagia,Swallowing Disorders,Esophageal Dysphagia,Oropharyngeal Dysphagia,Deglutition Disorder,Disorders, Deglutition,Dysphagia, Esophageal,Dysphagia, Oropharyngeal,Swallowing Disorder
D004750 Enteral Nutrition Nutritional support given via the alimentary canal or any route connected to the gastrointestinal system (i.e., the enteral route). This includes oral feeding, sip feeding, and tube feeding using nasogastric, gastrostomy, and jejunostomy tubes. Enteral Feeding,Force Feeding,Nutrition, Enteral,Tube Feeding,Gastric Feeding Tubes,Feeding Tube, Gastric,Feeding Tubes, Gastric,Feeding, Enteral,Feeding, Force,Feeding, Tube,Feedings, Force,Force Feedings,Gastric Feeding Tube,Tube, Gastric Feeding,Tubes, Gastric Feeding
D005260 Female Females
D005774 Gastrostomy Creation of an artificial external opening into the stomach for nutritional support or gastrointestinal compression. Gastrostomies
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000071066 Patient Reported Outcome Measures Assessment of the quality and effectiveness of health care as measured and directly reported by the patient. Patient Reported Outcome Measure,Patient-Reported Outcome,Patient-Reported Outcomes,Patient Reported Outcome,Patient Reported Outcomes,Outcome, Patient Reported,Outcome, Patient-Reported
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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