Assessment of Patient-Reported Outcome Measures in Patients Undergoing Bowel Preparation With Mannitol for Colonoscopy: The SATISFACTION Study.

IF 1.5 Q3 GASTROENTEROLOGY & HEPATOLOGY

JGH Open Pub Date : 2025-08-07 eCollection Date: 2025-08-01 DOI:10.1002/jgh3.70237

Gian Eugenio Tontini, Cristiano Spada, Peter Uebel, Renato Cannizzaro, Giorgio Ciprandi, Maurizio Vecchi

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Abstract

Background: Bowel preparation for colonoscopy causes significant discomfort to patients. Large volumes, unpleasant taste, and split-dosing are the main disadvantages of most laxatives. Oral mannitol could be an attractive option because it acts quickly, requires low volumes, and has a pleasant taste.

Aims: A Phase III study (SATISFACTION) compared oral mannitol with polyethylene glycol-ascorbate (PEG-ADC). This post hoc analysis investigated the effects on patient-reported outcomes (PROMs), mainly concerning the perception of using the preparations.

Methods: The SATISFACTION Phase III study was an international, multicenter, randomized (1:1), parallel-group, endoscopist-blinded, non-inferiority trial. Taste of preparations, ease of use, and willingness to repeat the preparation with the same product were scored and assessed by the patients.

Results: Bowel preparation with oral mannitol resulted in a better patient satisfaction profile for all PROMs evaluated.

Conclusion: Oral mannitol for bowel preparation achieved high patient satisfaction and might be a valuable option for colonoscopy.

Trial registration: ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885).

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对接受甘露醇肠道准备用于结肠镜检查的患者报告的结果评估：满意度研究。

背景：结肠镜检查前的肠道准备会给患者带来明显的不适。体积大，味道不好，分开给药是大多数泻药的主要缺点。口服甘露醇可能是一个有吸引力的选择，因为它起作用快，用量少，味道好。目的：一项III期研究（SATISFACTION）比较了口服甘露醇和聚乙二醇抗坏血酸酯（PEG-ADC）。该事后分析调查了对患者报告结果（PROMs）的影响，主要涉及使用制剂的感知。方法：SATISFACTION III期研究是一项国际、多中心、随机（1:1）、平行组、内镜盲法、非劣效性试验。患者对制剂的味道、易用性和使用相同产品重复制剂的意愿进行评分和评估。结果：口服甘露醇肠道准备对所有评估的PROMs患者有更好的满意度。结论：口服甘露醇用于肠道准备的患者满意度高，可能是结肠镜检查的有价值的选择。试验注册：ClinicalTrials.gov （https://clinicaltrials.gov/ct2/show/NCT04759885）。

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