Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial
Abstract Background The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducing need for medication. The objective of the ACCURE trial is to assess t...
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| Format: | Article |
| Language: | English |
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BMC
2024-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-08037-5 |
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| author | Eva Visser Lianne Heuthorst Shri Pathmakanthan Willem A. Bemelman Geert R. D’Haens Kelly Handley Apostolos Fakis Thomas D. Pinkney Christianne J. Buskens Marcel G. W. Dijkgraaf |
| author_facet | Eva Visser Lianne Heuthorst Shri Pathmakanthan Willem A. Bemelman Geert R. D’Haens Kelly Handley Apostolos Fakis Thomas D. Pinkney Christianne J. Buskens Marcel G. W. Dijkgraaf |
| author_sort | Eva Visser |
| collection | DOAJ |
| description | Abstract Background The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducing need for medication. The objective of the ACCURE trial is to assess the efficacy of laparoscopic appendectomy in addition to standard medical treatment in maintaining remission in UC patients. This article presents the statistical analysis plan to evaluate the outcomes of the ACCURE trial. Design and methods The ACCURE trial was designed as a multicentre, randomised controlled trial. UC patients with a new diagnosis or a disease relapse within the past 12 months, treated with 5-ASA, corticosteroids, or immunomodulators until complete clinical and endoscopic remission (defined as total Mayo score < 3 with endoscopic subscore of 0 or 1), were counselled for inclusion. Also, patients previously treated with biologicals who had a washout period of at least 3 months were considered for inclusion. Patients were randomised (1:1) to laparoscopic appendectomy plus maintenance treatment or a control group (maintenance therapy only). The primary outcome is the 1-year UC relapse rate (defined as a total Mayo-score ≥ 5 with endoscopic subscore of 2 or 3, or clinically as an exacerbation of symptoms and rectal bleeding or FCP > 150 or intensified medical therapy other than 5-ASA therapy). Secondary outcomes include number of relapses per patient, time to first relapse, disease activity, number of colectomies, medication usage, and health-related quality of life. Discussion The ACCURE trial will provide comprehensive evidence whether adding an appendectomy to maintenance treatment is superior to maintenance treatment only in maintaining remission in UC patients. Trial registration Dutch Trial Register (NTR) NTR2883 . Registered May 3, 2011. ISRCTN, ISRCTN60945764 . Registered August 12, 2019. |
| first_indexed | 2024-04-24T16:12:58Z |
| format | Article |
| id | doaj.art-2602170777af489dba211b9c9a08e844 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-24T16:12:58Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2602170777af489dba211b9c9a08e8442024-03-31T11:34:17ZengBMCTrials1745-62152024-03-0125111110.1186/s13063-024-08037-5Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trialEva Visser0Lianne Heuthorst1Shri Pathmakanthan2Willem A. Bemelman3Geert R. D’Haens4Kelly Handley5Apostolos Fakis6Thomas D. Pinkney7Christianne J. Buskens8Marcel G. W. Dijkgraaf9Department of Surgery, Amsterdam University Medical CentreDepartment of Surgery, Amsterdam University Medical CentreDepartment of Gastroenterology, Queen Elizabeth University Hospital BirminghamDepartment of Surgery, Amsterdam University Medical CentreDepartment of Gastroenterology and Hepatology, Amsterdam University Medical CentreUniversity of Birmingham Clinical Trials UnitDerby Clinical Trials Support Unit, University Hospitals of Derby and Burton NHS Foundation TrustAcademic Department of Surgery, University of BirminghamDepartment of Surgery, Amsterdam University Medical CentreDepartment of Epidemiology and Data Science, University Medical CentreAbstract Background The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducing need for medication. The objective of the ACCURE trial is to assess the efficacy of laparoscopic appendectomy in addition to standard medical treatment in maintaining remission in UC patients. This article presents the statistical analysis plan to evaluate the outcomes of the ACCURE trial. Design and methods The ACCURE trial was designed as a multicentre, randomised controlled trial. UC patients with a new diagnosis or a disease relapse within the past 12 months, treated with 5-ASA, corticosteroids, or immunomodulators until complete clinical and endoscopic remission (defined as total Mayo score < 3 with endoscopic subscore of 0 or 1), were counselled for inclusion. Also, patients previously treated with biologicals who had a washout period of at least 3 months were considered for inclusion. Patients were randomised (1:1) to laparoscopic appendectomy plus maintenance treatment or a control group (maintenance therapy only). The primary outcome is the 1-year UC relapse rate (defined as a total Mayo-score ≥ 5 with endoscopic subscore of 2 or 3, or clinically as an exacerbation of symptoms and rectal bleeding or FCP > 150 or intensified medical therapy other than 5-ASA therapy). Secondary outcomes include number of relapses per patient, time to first relapse, disease activity, number of colectomies, medication usage, and health-related quality of life. Discussion The ACCURE trial will provide comprehensive evidence whether adding an appendectomy to maintenance treatment is superior to maintenance treatment only in maintaining remission in UC patients. Trial registration Dutch Trial Register (NTR) NTR2883 . Registered May 3, 2011. ISRCTN, ISRCTN60945764 . Registered August 12, 2019.https://doi.org/10.1186/s13063-024-08037-5Statistical analysis planInflammatory bowel diseaseUlcerative colitisAppendectomyDisease recurrence |
| spellingShingle | Eva Visser Lianne Heuthorst Shri Pathmakanthan Willem A. Bemelman Geert R. D’Haens Kelly Handley Apostolos Fakis Thomas D. Pinkney Christianne J. Buskens Marcel G. W. Dijkgraaf Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial Trials Statistical analysis plan Inflammatory bowel disease Ulcerative colitis Appendectomy Disease recurrence |
| title | Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial |
| title_full | Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial |
| title_fullStr | Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial |
| title_full_unstemmed | Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial |
| title_short | Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial |
| title_sort | clinical statistical analysis plan for the accure trial the effect of appendectomy on the clinical course of ulcerative colitis a randomised international multicentre trial |
| topic | Statistical analysis plan Inflammatory bowel disease Ulcerative colitis Appendectomy Disease recurrence |
| url | https://doi.org/10.1186/s13063-024-08037-5 |
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