Sudheer K Vuyyuru, Christopher Ma, Tanmay Sharma, Tran M Nguyen, Talat Bessissow, Neeraj Narula, Siddharth Singh, Florian Rieder, Vipul Jairath
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Most studies investigated devices (n = 122 [48.2%]), or surgical procedures (n = 63 [24.9%]), followed by behavioral interventions (n = 30 [11.8%]), drugs (n = 20 [7.9%]), dietary interventions (n = 2 [0.8%]), skin care products (n = 2 0.8%]), and others (n = 14 [5.5%]). A total of 50.9% (n = 129) of studies had completed recruitment, enrolling 11 116 participants. Only 6 studies (surgery: n = 3; physiological studies: n = 2; drugs: n = 1) exclusively included patients with inflammatory bowel disease (IBD), and 16 studies commented that patients with IBD were excluded in their eligibility criteria. No study assessed efficacy of drugs in patients with CD and IS. Approximately one-quarter of studies (n = 65 of 253) included quality of life as an outcome measure.</p><p><strong>Conclusion: </strong>There is a paucity of research in IBD patients with IS, with the majority focusing on devices and surgical procedures. There have been no drug trials evaluating efficacy in patients with CD and IS. There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures that enable the inclusion of patients with CD with stoma into clinical trials.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":null,"pages":null},"PeriodicalIF":4.5000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.\",\"authors\":\"Sudheer K Vuyyuru, Christopher Ma, Tanmay Sharma, Tran M Nguyen, Talat Bessissow, Neeraj Narula, Siddharth Singh, Florian Rieder, Vipul Jairath\",\"doi\":\"10.1093/ibd/izad293\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This systematic review was performed to characterize the landscape of research conducted in patients with intestinal stoma (IS) and highlight unmet needs for clinical research in Crohn's disease (CD) and IS.</p><p><strong>Methods: </strong>We searched ClinicalTrials.gov from inception to May 25, 2022, to identify clinical trials assessing interventions in patients with an IS, as well as those with an IS and CD. Studies were grouped according to type of intervention. We excluded observational studies with no treatment arm.</p><p><strong>Results: </strong>A total of 253 studies were included in the final analysis. Most studies investigated devices (n = 122 [48.2%]), or surgical procedures (n = 63 [24.9%]), followed by behavioral interventions (n = 30 [11.8%]), drugs (n = 20 [7.9%]), dietary interventions (n = 2 [0.8%]), skin care products (n = 2 0.8%]), and others (n = 14 [5.5%]). A total of 50.9% (n = 129) of studies had completed recruitment, enrolling 11 116 participants. Only 6 studies (surgery: n = 3; physiological studies: n = 2; drugs: n = 1) exclusively included patients with inflammatory bowel disease (IBD), and 16 studies commented that patients with IBD were excluded in their eligibility criteria. No study assessed efficacy of drugs in patients with CD and IS. Approximately one-quarter of studies (n = 65 of 253) included quality of life as an outcome measure.</p><p><strong>Conclusion: </strong>There is a paucity of research in IBD patients with IS, with the majority focusing on devices and surgical procedures. There have been no drug trials evaluating efficacy in patients with CD and IS. There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures that enable the inclusion of patients with CD with stoma into clinical trials.</p>\",\"PeriodicalId\":13623,\"journal\":{\"name\":\"Inflammatory Bowel Diseases\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2024-11-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Inflammatory Bowel Diseases\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ibd/izad293\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Inflammatory Bowel Diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ibd/izad293","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:本系统综述旨在描述针对肠造口术(IS)患者开展的研究情况,并强调克罗恩病(CD)和肠造口术临床研究中尚未满足的需求:本系统综述旨在描述针对肠造口术(IS)患者开展的研究情况,并强调克罗恩病(CD)和IS临床研究中尚未满足的需求:我们搜索了从开始到 2022 年 5 月 25 日的 ClinicalTrials.gov,以确定对 IS 患者以及 IS 和 CD 患者的干预措施进行评估的临床试验。研究根据干预类型进行分组。我们排除了没有治疗臂的观察性研究:最终分析共纳入了 253 项研究。大多数研究调查了设备(n = 122 [48.2%])或外科手术(n = 63 [24.9%]),其次是行为干预(n = 30 [11.8%])、药物(n = 20 [7.9%])、饮食干预(n = 2 [0.8%])、护肤品(n = 2 0.8%])和其他(n = 14 [5.5%])。共有 50.9% 的研究(n = 129)完成了招募工作,共招募了 11 116 名参与者。只有 6 项研究(手术:n = 3;生理研究:n = 2;药物:n = 1)专门纳入了炎症性肠病 (IBD) 患者,16 项研究在其资格标准中注明不包括 IBD 患者。没有一项研究评估了药物对 CD 和 IS 患者的疗效。约四分之一的研究(253 项研究中的 65 项)将生活质量作为结果测量指标:结论:针对IBD合并IS患者的研究很少,大多数研究都集中在器械和外科手术方面。目前还没有药物试验对 CD 和 IS 患者的疗效进行评估。当务之急是找出入组的障碍,并制定资格和结果衡量标准,以便将造口的 CD 患者纳入临床试验。
Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.
Background: This systematic review was performed to characterize the landscape of research conducted in patients with intestinal stoma (IS) and highlight unmet needs for clinical research in Crohn's disease (CD) and IS.
Methods: We searched ClinicalTrials.gov from inception to May 25, 2022, to identify clinical trials assessing interventions in patients with an IS, as well as those with an IS and CD. Studies were grouped according to type of intervention. We excluded observational studies with no treatment arm.
Results: A total of 253 studies were included in the final analysis. Most studies investigated devices (n = 122 [48.2%]), or surgical procedures (n = 63 [24.9%]), followed by behavioral interventions (n = 30 [11.8%]), drugs (n = 20 [7.9%]), dietary interventions (n = 2 [0.8%]), skin care products (n = 2 0.8%]), and others (n = 14 [5.5%]). A total of 50.9% (n = 129) of studies had completed recruitment, enrolling 11 116 participants. Only 6 studies (surgery: n = 3; physiological studies: n = 2; drugs: n = 1) exclusively included patients with inflammatory bowel disease (IBD), and 16 studies commented that patients with IBD were excluded in their eligibility criteria. No study assessed efficacy of drugs in patients with CD and IS. Approximately one-quarter of studies (n = 65 of 253) included quality of life as an outcome measure.
Conclusion: There is a paucity of research in IBD patients with IS, with the majority focusing on devices and surgical procedures. There have been no drug trials evaluating efficacy in patients with CD and IS. There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures that enable the inclusion of patients with CD with stoma into clinical trials.
期刊介绍:
Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.