Mannitol for bowel preparation: Efficacy and safety results from the SATISFACTION randomised clinical trial.

IF 4 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease Pub Date : 2024-11-18 DOI:10.1016/j.dld.2024.09.024

Maurizio Vecchi, Gian Eugenio Tontini, Giancarla Fiori, Paolo Bocus, Marino Carnovali, Paola Cesaro, Guido Costamagna, Dhanai Di Paolo, Luca Elli, Olga Fedorishina, Carsten Hinkel, Ralf Jakobs, Sergey Kashin, Michela Magnoli, Gianpiero Manes, Ekaterina Melnikova, Anna Orsatti, Thierry Ponchon, Alberto Prada, Franco Radaelli, Sandro Sferrazza, Pietro Soru, Jean Christophe Valats, Victor Veselov, Cristiano Spada, Peter Uebel

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引用次数: 0

Abstract

Background: Bowel preparation represents a significant issue to high-quality colonoscopy. Oral mannitol requires a single dose, is of low volume, and has a pleasant taste and rapid action.

Aims: This SATISFACTION study compared single-dose (same day) oral mannitol 100 g/750 mL with standard split-dose PEG-ASC2 L (MoviPrep®).

Methods: The primary endpoint was the proportion of patients with adequate bowel cleansing. Secondary endpoints included efficacy (adenoma detection rate, caecal intubation rate, time of evacuation), safety (intestinal gases concentration, haemato-chemical parameters, adverse events), and patient satisfaction.

Results: The study included 703 patients (352 treated with mannitol and 351 with PEG-ASC). Mannitol was not inferior to PEG-ASC for the primary endpoint (91.1 % and 95.5 %, respectively; p-value for the non-inferiority =0.0131). There was no significant difference for secondary efficacy endpoints. The acceptability profile was significantly better in the mannitol group for ease of use, taste, and willingness to reuse (p < 0.0001 for all). The concentration of intestinal gases (H₂, CH₄) was similar between groups and well below those potentially critical.

Conclusions: The SATISFACTION study indicated that low-volume, single-dose mannitol may satisfy an unmet clinical need since it was more acceptable to the patient and not inferior to the split-dose PEG-ASC for bowel cleansing efficacy.

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用于肠道准备的甘露醇：SATISFACTION 随机临床试验的疗效和安全性结果。

背景：肠道准备是高质量结肠镜检查的一个重要问题。目的：这项 SATISFACTION 研究比较了单剂量（当天）口服甘露醇 100 克/750 毫升和标准分剂量 PEG-ASC2 L（MoviPrep®）：主要终点是充分清洁肠道的患者比例。次要终点包括疗效（腺瘤检出率、盲肠插管率、排空时间）、安全性（肠道气体浓度、血液化学参数、不良事件）和患者满意度：研究包括 703 名患者（其中 352 人接受甘露醇治疗，351 人接受 PEG-ASC 治疗）。就主要终点而言，甘露醇的疗效不逊于 PEG-ASC（分别为 91.1% 和 95.5%；非劣效性的 p 值 =0.0131）。次要疗效终点无明显差异。在易用性、口感和重复使用意愿方面，甘露醇组的可接受性明显更好（均为 p <0.0001）。各组的肠道气体（H2、CH4）浓度相似，远低于潜在的临界值：SATISFACTION 研究表明，小剂量、单剂量甘露醇可以满足尚未满足的临床需求，因为它更容易被患者接受，而且在肠道清洁效果方面并不比分剂量 PEG-ASC 差。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Digestive and Liver Disease 医学-胃肠肝病学

CiteScore

6.10

自引率

2.20%

发文量

632

审稿时长

19 days

期刊介绍： Digestive and Liver Disease is an international journal of Gastroenterology and Hepatology. It is the official journal of Italian Association for the Study of the Liver (AISF); Italian Association for the Study of the Pancreas (AISP); Italian Association for Digestive Endoscopy (SIED); Italian Association for Hospital Gastroenterologists and Digestive Endoscopists (AIGO); Italian Society of Gastroenterology (SIGE); Italian Society of Pediatric Gastroenterology and Hepatology (SIGENP) and Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). Digestive and Liver Disease publishes papers on basic and clinical research in the field of gastroenterology and hepatology. Contributions consist of: Original Papers Correspondence to the Editor Editorials, Reviews and Special Articles Progress Reports Image of the Month Congress Proceedings Symposia and Mini-symposia.