{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T14:24:14Z","timestamp":1793283854925,"version":"4.5.0"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2023,12,22]],"date-time":"2023-12-22T00:00:00Z","timestamp":1703203200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,11,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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\u2019s disease (CD) and IS.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 253 studies were included in the final analysis. Most studies investigated devices (n\u2005=\u2005122 [48.2%]), or surgical procedures (n\u2005=\u200563 [24.9%]), followed by behavioral interventions (n\u2005=\u200530 [11.8%]), drugs (n\u2005=\u200520 [7.9%]), dietary interventions (n\u2005=\u20052 [0.8%]), skin care products (n\u2005=\u20052 0.8%]), and others (n\u2005=\u200514 [5.5%]). A total of 50.9% (n\u2005=\u2005129) of studies had completed recruitment, enrolling 11\u2005116 participants. Only 6 studies (surgery: n\u2005=\u20053; physiological studies: n\u2005=\u20052; drugs: n\u2005=\u20051) 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izad293","type":"journal-article","created":{"date-parts":[[2023,12,23]],"date-time":"2023-12-23T04:08:36Z","timestamp":1703304516000},"page":"2037-2045","source":"Crossref","is-referenced-by-count":6,"title":["Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease"],"prefix":"10.1093","volume":"30","author":[{"given":"Sudheer K","family":"Vuyyuru","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4698-9948","authenticated-orcid":false,"given":"Christopher","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Community Health Sciences, Cumming School of Medicine, University of Calgary , Calgary, AB ,","place":["Canada"]},{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary , Calgary, AB ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanmay","family":"Sharma","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tran M","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Lawson Health Research Institute, Western University , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2610-1910","authenticated-orcid":false,"given":"Talat","family":"Bessissow","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, McGill University Health Center , Montreal, QC ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1536-8436","authenticated-orcid":false,"given":"Neeraj","family":"Narula","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University , Hamilton, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siddharth","family":"Singh","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, University of California, San Diego , La Jolla, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Rieder","sequence":"additional","affiliation":[{"name":"Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation , Cleveland, OH ,","place":["USA"]},{"name":"Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation , Cleveland, OH ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1092-0033","authenticated-orcid":false,"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University , London, ON ,","place":["Canada"]},{"name":"Lawson Health Research Institute, Western University , London, ON ,","place":["Canada"]},{"name":"Department of Epidemiology and Biostatistics, Western University , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,12,22]]},"reference":[{"key":"2025052401371007100_CIT0001","author":"Ostomy Canada Society"},{"issue":"11","key":"2025052401371007100_CIT0002","doi-asserted-by":"crossref","first-page":"1279","DOI":"10.1111\/codi.14731","article-title":"Reduction in surgical stoma rates in Crohn\u2019s disease: a population-based time trend analysis","volume":"21","author":"Ma","year":"2019","journal-title":"Colorectal Dis."},{"issue":"8","key":"2025052401371007100_CIT0003","doi-asserted-by":"crossref","first-page":"1160","DOI":"10.1093\/ibd\/izab245","article-title":"Probability of stoma in incident patients with Crohn\u2019s disease in Sweden 2003-2019: a population-based study","volume":"28","author":"Everhov","year":"2022","journal-title":"Inflamm Bowel Dis."},{"issue":"12","key":"2025052401371007100_CIT0004","doi-asserted-by":"crossref","first-page":"1629","DOI":"10.1002\/bjs.1800821213","article-title":"Experience with ileostomy and colostomy in Crohn\u2019s disease","volume":"82","author":"Post","year":"1995","journal-title":"Br J Surg."},{"issue":"10","key":"2025052401371007100_CIT0005","doi-asserted-by":"crossref","first-page":"958","DOI":"10.1111\/j.1463-1318.2009.02006.x","article-title":"Stoma complications: a literature overview","volume":"12","author":"Shabbir","year":"2010","journal-title":"Colorectal Dis."},{"issue":"7","key":"2025052401371007100_CIT0006","doi-asserted-by":"crossref","first-page":"1236","DOI":"10.1097\/MIB.0000000000000072","article-title":"Natural history of Crohn\u2019s disease following total colectomy and end ileostomy","volume":"20","author":"Lopez","year":"2014","journal-title":"Inflamm Bowel Dis."},{"issue":"7","key":"2025052401371007100_CIT0007","doi-asserted-by":"crossref","first-page":"1285","DOI":"10.14309\/ajg.0000000000002215","article-title":"Patients with Crohn\u2019s disease and permanent ileostomy are universally excluded from clinical trials: a systematic review","volume":"118","author":"Vuyyuru","year":"2023","journal-title":"Am J Gastroenterol."},{"issue":"3","key":"2025052401371007100_CIT0008","doi-asserted-by":"crossref","first-page":"251","DOI":"10.1097\/WON.0000000000000876","article-title":"Ostomy and continent diversion patient bill of rights: research validation of standards of care","volume":"49","author":"Burgess-Stocks","year":"2022","journal-title":"J Wound Ostomy Continence Nurs"},{"issue":"2","key":"2025052401371007100_CIT0009","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1093\/ecco-jcc\/jjz187","article-title":"ECCO guidelines on therapeutics in Crohn\u2019s disease: surgical treatment","volume":"14","author":"Adamina","year":"2019","journal-title":"J Crohns Colitis."},{"issue":"3","key":"2025052401371007100_CIT0010","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1111\/apt.13886","article-title":"Systematic review with meta-analysis: recurrence of Crohn\u2019s disease after total colectomy with permanent ileostomy","volume":"45","author":"Fumery","year":"2017","journal-title":"Aliment Pharmacol Ther."},{"issue":"2","key":"2025052401371007100_CIT0011","doi-asserted-by":"crossref","first-page":"76","DOI":"10.1007\/s003840000279","article-title":"Reoperations at the ileostomy in Crohn\u2019s disease reflect inflammatory activity rather than surgical stoma complications alone","volume":"16","author":"Ecker","year":"2001","journal-title":"Int J Colorectal Dis."},{"issue":"6","key":"2025052401371007100_CIT0012","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1097\/WON.0000000000000590","article-title":"The financial impact of living in Canada with an ostomy: a cross-sectional survey","volume":"46","author":"LeBlanc","year":"2019","journal-title":"J Wound Ostomy Continence Nurs."},{"issue":"5","key":"2025052401371007100_CIT0013","first-page":"993","article-title":"Quality of life in patients living with stoma","volume":"31","author":"Zewude","year":"2021","journal-title":"Ethiop J Health Sci."},{"issue":"7","key":"2025052401371007100_CIT0014","doi-asserted-by":"crossref","first-page":"376","DOI":"10.12968\/bjon.2022.31.7.376","article-title":"Challenges faced by people with a stoma: peristomal body profile risk factors and leakage","volume":"31","author":"Martins","year":"2022","journal-title":"Br J Nurs."},{"key":"2025052401371007100_CIT0015","doi-asserted-by":"crossref","first-page":"1001232","DOI":"10.3389\/fpsyt.2022.1001232","article-title":"Prevalence of depression and its potential contributing factors in patients with enterostomy: a meta-analytical review","volume":"13","author":"Tang","year":"2022","journal-title":"Front Psychiatry."},{"issue":"12","key":"2025052401371007100_CIT0016","doi-asserted-by":"crossref","first-page":"2020","DOI":"10.1002\/pon.5988","article-title":"The prevalence of anxiety and depression in patients with ostomy: a systematic review and meta-analysis","volume":"31","author":"Farahani","year":"2022","journal-title":"Psychooncology."},{"issue":"5","key":"2025052401371007100_CIT0017","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1097\/WON.0000000000000895","article-title":"Adjustment to an ostomy: an integrative literature review","volume":"49","author":"Kittscha","year":"2022","journal-title":"J Wound Ostomy Continence Nurs."},{"issue":"1","key":"2025052401371007100_CIT0018","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1097\/WON.0000000000000396","article-title":"WOCN society clinical guideline: management of the adult patient with a fecal or urinary ostomy-an executive summary","volume":"45","author":"Wound, Ostomy, and Continence Nurses Society; Guideline Development Task Force","year":"2018","journal-title":"J Wound Ostomy Continence Nurs."},{"issue":"10","key":"2025052401371007100_CIT0019","doi-asserted-by":"crossref","first-page":"1173","DOI":"10.1097\/DCR.0000000000002498","article-title":"The American Society of colon and rectal surgeons clinical practice guidelines for ostomy surgery","volume":"65","author":"Davis","year":"2022","journal-title":"Dis Colon Rectum."},{"issue":"1","key":"2025052401371007100_CIT0020","doi-asserted-by":"crossref","first-page":"74","DOI":"10.1097\/WON.0000000000000297","article-title":"Executive summary: enhanced recovery after surgery: best practice guideline for care of patients with a fecal diversion","volume":"44","author":"Miller","year":"2017","journal-title":"J Wound Ostomy Continence Nurs."},{"issue":"12","key":"2025052401371007100_CIT0021","doi-asserted-by":"crossref","first-page":"2067","DOI":"10.1007\/s10350-007-9006-5","article-title":"Long-term quality of life in patients with Crohn\u2019s disease and perianal fistulas: influence of fecal diversion","volume":"50","author":"Kasparek","year":"2007","journal-title":"Dis Colon Rectum."},{"key":"2025052401371007100_CIT0022","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1136\/qhc.12.1.18","article-title":"Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project","volume":"12","author":"AGREE Collaboration","year":"2003","journal-title":"Qual Saf Health Care."},{"key":"2025052401371007100_CIT0023","doi-asserted-by":"crossref","first-page":"856325","DOI":"10.3389\/fpubh.2022.856325","article-title":"Quality assessment of the clinical practice guidelines of ostomy care based on the AGREE II instrument","volume":"10","author":"Li","year":"2022","journal-title":"Front Public Health."}],"container-title":["Inflammatory Bowel Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ibdjournal\/advance-article-pdf\/doi\/10.1093\/ibd\/izad293\/54770463\/izad293.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/30\/11\/2037\/59882131\/izad293.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/30\/11\/2037\/59882131\/izad293.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,24]],"date-time":"2025-05-24T05:37:23Z","timestamp":1748065043000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article\/30\/11\/2037\/7492214"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,22]]},"references-count":23,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2023,12,22]]},"published-print":{"date-parts":[[2024,11,4]]}},"URL":"https:\/\/doi.org\/10.1093\/ibd\/izad293","relation":{},"ISSN":["1078-0998","1536-4844"],"issn-type":[{"value":"1078-0998","type":"print"},{"value":"1536-4844","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,11]]},"published":{"date-parts":[[2023,12,22]]}}}