Restrictive diets are unnecessary for colonoscopy: Non-inferiority randomized trial

Author:

Machlab Salvador12ORCID,Martínez-Bauer Eva12,López Pilar3,Ruiz-Ramirez Pablo4,Gómez Bárbara5,Gimeno-Garcia Antonio Z.6,Pujals María del Mar4,Tanco Sara5,Sargatal Lluïsa7,Pérez Betty6,Justicia Reyes8,Enguita Mónica9,Piqué Nùria10,Valero Oliver11,Calvet Xavier212,Campo Rafel12

Affiliation:

1. Digestive Endoscopy Unit, Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Sabadell, Spain

2. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain

3. Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari. Institut d’Investigació i Innovació Parc Taulí I3PT, Sabadell, Spain

4. Gastroenterology Department, Hospital Universitari Mùtua de Terrassa, Terrassa, Spain

5. Gastroenterology Department, Hospital de Mataró, Mataró, Spain

6. Gastroenterología, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain

7. Gastroenterology Department, Consorci Sanitari de Terrassa, Terrassa, Spain

8. Colorectal Cancer Screening Office, Consorci Sanitari de Terrassa, Terrassa, Spain

9. Methodology Unit, Navarrabiomed, Pamplona, Spain

10. Institut de Recerca en Nutrició i Seguretat Alimentària de la UB (INSA-UB), Universitat de Barcelona Facultat de Farmàcia i Ciències de l'Alimentació, Barcelona, Spain

11. Mathematics Department and Applied Statistics, Universitat Autonoma de Barcelona, Barcelona, Spain

12. Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d’Investigació i Innovació Parc Taulí I3PT, Sabadell, Spain

Abstract

Abstract Background and study aims In colonoscopy, preparation is often regarded as the most burdensome part of the intervention. Traditionally, specific diets have been recommended, but the evidence to support this policy is insufficient. The aim of this study was to evaluate the impact of the decision not to follow a restrictive diet on bowel preparation and colonoscopy outcomes. Patients and methods This was a multicenter, controlled, non-inferiority randomized trial with FIT-positive screening colonoscopy. The subjects were assigned to follow the current standard (1-day low residue diet [LRD]) or a liberal diet. The allocation was balanced for the risk of inadequate cleansing using the Dik et al. score. All participants received the same instructions for morning colonoscopy preparation. The primary outcome was the rate of adequate preparations as defined by the Boston Bowel Preparation Scale. Secondary outcomes included tolerability and measures of colonoscopy performance and quality. Results A total of 582 subjects were randomized. Of these, 278 who received the liberal diet and 275 who received the 1-day LRD were included in the intent-to-treat analysis. Non-inferiority was demonstrated with adequate preparation rates of 97.8% in the 1-day LRD and 96.4% in the liberal diet group. Tolerability was higher with the liberal diet (94.7% vs. 83.2%). No differences were found with respect to cecal intubation time, aspirated volume, or length of the examination. Global and right colon average adenoma detection rates per colonoscopy were similar. Conclusions The liberal diet was non-inferior to the 1-day LRD, and increased tolerability. Colonoscopy performance and quality were not affected. (NCT05032794)

Publisher

Georg Thieme Verlag KG

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