Open Access
CC BY-NC-ND 4.0 · Endosc Int Open 2024; 12(03): E352-E360
DOI: 10.1055/a-2256-5356
Original article

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

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 (Ringgold ID: RIN73069)
,
Eva Martínez-Bauer
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 (Ringgold ID: RIN73069)
,
Pilar López
3   Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari. Institut d’Investigació i Innovació Parc Taulí I3PT, Sabadell, Spain
,
Pablo Ruiz-Ramirez
4   Gastroenterology Department, Hospital Universitari Mùtua de Terrassa, Terrassa, Spain
,
Bárbara Gómez
5   Gastroenterology Department, Hospital de Mataró, Mataró, Spain
,
Antonio Z. Gimeno-Garcia
6   Gastroenterología, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain
,
María del Mar Pujals
4   Gastroenterology Department, Hospital Universitari Mùtua de Terrassa, Terrassa, Spain
,
Sara Tanco
5   Gastroenterology Department, Hospital de Mataró, Mataró, Spain
,
Lluïsa Sargatal
7   Gastroenterology Department, Consorci Sanitari de Terrassa, Terrassa, Spain
,
Betty Pérez
6   Gastroenterología, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain
,
Reyes Justicia
8   Colorectal Cancer Screening Office, Consorci Sanitari de Terrassa, Terrassa, Spain
,
Mónica Enguita
9   Methodology Unit, Navarrabiomed, Pamplona, Spain (Ringgold ID: RIN561036)
,
Nùria Piqué
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 (Ringgold ID: RIN73070)
,
Oliver Valero
11   Mathematics Department and Applied Statistics, Universitat Autonoma de Barcelona, Barcelona, Spain (Ringgold ID: RIN16719)
,
Xavier Calvet
2   Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain (Ringgold ID: RIN73069)
12   Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d’Investigació i Innovació Parc Taulí I3PT, Sabadell, Spain
,
Rafel Campo
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 (Ringgold ID: RIN73069)
› Author Affiliations
Clinical Trial: Registration number (trial ID): NCT05032794, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Randomized, multicenter, no-inferiority clinical trial
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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)

Supplementary Material



Publication History

Received: 22 September 2023

Accepted after revision: 06 January 2024

Accepted Manuscript online:
29 January 2024

Article published online:
07 March 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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