Research & Development, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
BMJ Open. 2022 Mar 30;12(3):e058559. doi: 10.1136/bmjopen-2021-058559.
Demand for colonoscopies and CT colonography (CTC) is exceeding capacity in National Health Service Trusts. In many patients colonoscopies and CTCs show no significant bowel disease (SBD). Faecal Immunochemical Testing (FIT) is being introduced to prioritise patients for colonoscopies but is insufficient to identify non-SBD patients meaning colonoscopy and CTC demand remains high. The REducing Colonoscopies in patients without significant bowEl DiseasE (RECEDE) study aims to test urine volatile organic compound (VOC) analysis alongside FIT to improve detection of SBD and to reduce the number of colonoscopies and CTCs.
This is a multicentre, prospective diagnostic accuracy study evaluating whether stool FIT plus urine VOC compared with stool FIT alone improves detection of SBD in patients referred for colonoscopy or CTC due to persistent lower gastrointestinal symptoms. To ensure SBD is not missed, the dual test requires a high sensitivity, set at 97% with 95% CI width of 5%. Our assumption is that to achieve this sensitivity requires 200 participants with SBD. Further assuming 19% of all participants will have SBD and 55% of all participants will return both stool and urine samples we will recruit 1915 participants. The thresholds for FIT and VOC results diagnosing SBD have been pre-set. If either FIT or VOC exceeds the respective threshold, the participant will be classed as having suspected SBD. As an exploratory analysis we will be testing different thresholds. The reference comparator will be a complete colonoscopy or CTC. Secondary outcomes will look at optimising the FIT and VOC thresholds for SBD detection. An economic evaluation, using a denovo decision analytic model, will be carried out determine the costs, benefits and overall cost-effectiveness of FIT +VOC vs FIT followed by colonoscopy.
Ethical approval was obtained by Liverpool Central Research Ethics Committee (20/NW/0346).
RECEDE is registered on Clinicaltrials.gov NCT04516785 & ISRCTN14982373. This protocol was written and published before results of the trial were available.
在国民保健制度信托基金中，结肠镜检查和 CT 结肠成像（CTC）的需求超过了其容量。在许多患者中，结肠镜检查和 CTC 并未显示出明显的肠道疾病（SBD）。粪便免疫化学检测（FIT）的引入是为了优先安排结肠镜检查的患者，但不足以确定非 SBD 患者，这意味着结肠镜检查和 CTC 的需求仍然很高。减少无显著肠道疾病患者的结肠镜检查（RECEDE）研究旨在结合 FIT 测试尿液挥发性有机化合物（VOC）分析，以提高 SBD 的检测率，并减少结肠镜检查和 CTC 的数量。
这是一项多中心、前瞻性诊断准确性研究，评估粪便 FIT 加尿液 VOC 与单独粪便 FIT 相比，是否能提高因持续性下胃肠道症状而接受结肠镜检查或 CTC 检查的患者的 SBD 检出率。为了确保不遗漏 SBD，双检测需要高灵敏度，设定为 97%，95%置信区间宽度为 5%。我们假设，要达到这种灵敏度，需要 200 名 SBD 患者。进一步假设所有参与者中有 19%患有 SBD，并且所有参与者中有 55%会同时返回粪便和尿液样本，我们将招募 1915 名参与者。FIT 和 VOC 结果诊断 SBD 的阈值已经预先设定。如果 FIT 或 VOC 超过各自的阈值，参与者将被归类为疑似 SBD。作为一项探索性分析，我们将测试不同的阈值。参考比较器将是完整的结肠镜检查或 CTC。次要结果将着眼于优化用于 SBD 检测的 FIT 和 VOC 阈值。一项经济评估，使用新决策分析模型，将对 FIT +VOC 与 FIT 后结肠镜检查的成本、效益和总体成本效益进行评估。
利物浦中央研究伦理委员会（20/NW/0346）已获得伦理批准。
RECEDE 在 Clinicaltrials.gov 上注册（NCT04516785 & ISRCTN14982373）。本方案在试验结果公布之前编写和发布。
