Development and Validation of a Nomogram for Predicting Surgery in Newly-diagnosed Crohn's Disease: a Retrospective Cohort Study

NCT06457035 | Completed

• 1 other identifier: NOMOGRAM for Nd-CD
• Study Type: observational
• Target: 490
• Locations: 0 countries
• Sites: N/A

Brief Summary

A majority of patients with Crohn's disease undergo surgery during the disease course. We aimed to develop an easily available nomogram to predict the risk of surgery at diagnosis.

Conditions

Newly-diagnosed Crohn's Disease

Keywords

Crohn's disease; surgery; nomogram; prediction model

Outcome Measures

Primary Outcomes (1)

• Requirement of surgery

  need for bowel resection at any time

  Any time during the follow-up (up to Dec 31, 2022)

Interventions

immunosuppressant DRUG

No intervention was performed in this retrospective cohort study.

Also known as: biologics

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients newly diagnosed with Crohn's disease

You may qualify if:

• The diagnosis of CD was finally confirmed according to diagnostic criteria, including clinical manifestations and ileocolonoscopic, histopathologic, and radiologic evidence
• Laboratory data of complete blood count and routine blood biochemical examination were available within one week before the diagnostic ileocolonoscopy

You may not qualify if:

• The time of diagnosis was unclear
• They underwent bowel resection within three months after diagnosis, which reflected an early complicated disease
• They suffered from severe infection around the laboratory test

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (16)

• Roda G, Chien Ng S, Kotze PG, Argollo M, Panaccione R, Spinelli A, Kaser A, Peyrin-Biroulet L, Danese S. Crohn's disease. Nat Rev Dis Primers. 2020 Apr 2;6(1):22. doi: 10.1038/s41572-020-0156-2.

  PMID: 32242028 BACKGROUND

• Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.

  PMID: 16698746 BACKGROUND

• Thia KT, Sandborn WJ, Harmsen WS, Zinsmeister AR, Loftus EV Jr. Risk factors associated with progression to intestinal complications of Crohn's disease in a population-based cohort. Gastroenterology. 2010 Oct;139(4):1147-55. doi: 10.1053/j.gastro.2010.06.070. Epub 2010 Jul 14.

  PMID: 20637205 BACKGROUND

• Tarrant KM, Barclay ML, Frampton CM, Gearry RB. Perianal disease predicts changes in Crohn's disease phenotype-results of a population-based study of inflammatory bowel disease phenotype. Am J Gastroenterol. 2008 Dec;103(12):3082-93. doi: 10.1111/j.1572-0241.2008.02212.x.

  PMID: 19086959 BACKGROUND

• Louis E, Collard A, Oger AF, Degroote E, Aboul Nasr El Yafi FA, Belaiche J. Behaviour of Crohn's disease according to the Vienna classification: changing pattern over the course of the disease. Gut. 2001 Dec;49(6):777-82. doi: 10.1136/gut.49.6.777.

  PMID: 11709511 BACKGROUND

• Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289-97. doi: 10.1038/ajg.2009.579. Epub 2009 Oct 27.

  PMID: 19861953 BACKGROUND

• Bemelman WA, Warusavitarne J, Sampietro GM, Serclova Z, Zmora O, Luglio G, de Buck van Overstraeten A, Burke JP, Buskens CJ, Colombo F, Dias JA, Eliakim R, Elosua T, Gecim IE, Kolacek S, Kierkus J, Kolho KL, Lefevre JH, Millan M, Panis Y, Pinkney T, Russell RK, Shwaartz C, Vaizey C, Yassin N, D'Hoore A. ECCO-ESCP Consensus on Surgery for Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):1-16. doi: 10.1093/ecco-jcc/jjx061. No abstract available.

  PMID: 28498901 BACKGROUND

• Cushing K, Higgins PDR. Management of Crohn Disease: A Review. JAMA. 2021 Jan 5;325(1):69-80. doi: 10.1001/jama.2020.18936.

  PMID: 33399844 BACKGROUND

• Peyrin-Biroulet L, Oussalah A, Williet N, Pillot C, Bresler L, Bigard MA. Impact of azathioprine and tumour necrosis factor antagonists on the need for surgery in newly diagnosed Crohn's disease. Gut. 2011 Jul;60(7):930-6. doi: 10.1136/gut.2010.227884. Epub 2011 Jan 12.

  PMID: 21228429 BACKGROUND

• Jenkinson PW, Plevris N, Siakavellas S, Lyons M, Arnott ID, Wilson D, Watson AJM, Jones GR, Lees CW. Temporal Trends in Surgical Resection Rates and Biologic Prescribing in Crohn's Disease: A Population-based Cohort Study. J Crohns Colitis. 2020 Sep 16;14(9):1241-1247. doi: 10.1093/ecco-jcc/jjaa044.

  PMID: 32840295 BACKGROUND

• Ramadas AV, Gunesh S, Thomas GA, Williams GT, Hawthorne AB. Natural history of Crohn's disease in a population-based cohort from Cardiff (1986-2003): a study of changes in medical treatment and surgical resection rates. Gut. 2010 Sep;59(9):1200-6. doi: 10.1136/gut.2009.202101. Epub 2010 Jul 21.

  PMID: 20650924 BACKGROUND

• Kugathasan S, Denson LA, Walters TD, Kim MO, Marigorta UM, Schirmer M, Mondal K, Liu C, Griffiths A, Noe JD, Crandall WV, Snapper S, Rabizadeh S, Rosh JR, Shapiro JM, Guthery S, Mack DR, Kellermayer R, Kappelman MD, Steiner S, Moulton DE, Keljo D, Cohen S, Oliva-Hemker M, Heyman MB, Otley AR, Baker SS, Evans JS, Kirschner BS, Patel AS, Ziring D, Trapnell BC, Sylvester FA, Stephens MC, Baldassano RN, Markowitz JF, Cho J, Xavier RJ, Huttenhower C, Aronow BJ, Gibson G, Hyams JS, Dubinsky MC. Prediction of complicated disease course for children newly diagnosed with Crohn's disease: a multicentre inception cohort study. Lancet. 2017 Apr 29;389(10080):1710-1718. doi: 10.1016/S0140-6736(17)30317-3. Epub 2017 Mar 2.

  PMID: 28259484 BACKGROUND

• Forcione DG, Rosen MJ, Kisiel JB, Sands BE. Anti-Saccharomyces cerevisiae antibody (ASCA) positivity is associated with increased risk for early surgery in Crohn's disease. Gut. 2004 Aug;53(8):1117-22. doi: 10.1136/gut.2003.030734.

  PMID: 15247177 BACKGROUND

• Smids C, Horjus Talabur Horje CS, Nierkens S, Drylewicz J, Groenen MJM, Wahab PJ, van Lochem EG. Candidate Serum Markers in Early Crohn's Disease: Predictors of Disease Course. J Crohns Colitis. 2017 Sep 1;11(9):1090-1100. doi: 10.1093/ecco-jcc/jjx049.

  PMID: 28369318 BACKGROUND

• Stidham RW, Takenaka K. Artificial Intelligence for Disease Assessment in Inflammatory Bowel Disease: How Will it Change Our Practice? Gastroenterology. 2022 Apr;162(5):1493-1506. doi: 10.1053/j.gastro.2021.12.238. Epub 2022 Jan 4.

  PMID: 34995537 BACKGROUND

• Watson DS, Krutzinna J, Bruce IN, Griffiths CE, McInnes IB, Barnes MR, Floridi L. Clinical applications of machine learning algorithms: beyond the black box. BMJ. 2019 Mar 12;364:l886. doi: 10.1136/bmj.l886. No abstract available.

  PMID: 30862612 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Immunosuppressive Agents; Biological Products

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 13, 2024
• Study Start: January 1, 2005
• Primary Completion: December 31, 2022
• Study Completion: December 1, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06