Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial

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

doi:10.1186/s13063-024-08037-5

Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial

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

^*Corresponding author for this work

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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.

Original language	English
Article number	218
Number of pages	11
Journal	Trials
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s13063-024-08037-5
Publication status	Published - 26 Mar 2024

Bibliographical note

Funding:
The Dutch arm of this investigator-initiated study was funded by a grant from the charity fund: Nuts-Ohra (FNO 1202-008). The ACCURE-UK 2 was funded by the Efficacy and Mechanism Evaluation Programme branch of the National Institute for Health Research (IRAS project ID: 254954). The funders had no role in designing the study and data collection nor will they influence the analysis and writing process of the manuscript.

Keywords

Appendectomy
Ulcerative colitis
Disease recurrence
Inflammatory bowel disease
Statistical analysis plan

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Visser, E., Heuthorst, L., Pathmakanthan, S., Bemelman, W. A., D’Haens, G. R., Handley, K., Fakis, A., Pinkney, T. D., Buskens, C. J., & Dijkgraaf, M. G. W. (2024). 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, 25(1), Article 218. https://doi.org/10.1186/s13063-024-08037-5

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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.",

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author = "Eva Visser and Lianne Heuthorst and Shri Pathmakanthan and Bemelman, {Willem A.} and D{\textquoteright}Haens, {Geert R.} and Kelly Handley and Apostolos Fakis and Pinkney, {Thomas D.} and Buskens, {Christianne J.} and Dijkgraaf, {Marcel G. W.}",

note = "Funding: The Dutch arm of this investigator-initiated study was funded by a grant from the charity fund: Nuts-Ohra (FNO 1202-008). The ACCURE-UK 2 was funded by the Efficacy and Mechanism Evaluation Programme branch of the National Institute for Health Research (IRAS project ID: 254954). The funders had no role in designing the study and data collection nor will they influence the analysis and writing process of the manuscript.",

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Visser, E, Heuthorst, L, Pathmakanthan, S, Bemelman, WA, D’Haens, GR, Handley, K, Fakis, A, Pinkney, TD, Buskens, CJ & Dijkgraaf, MGW 2024, '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, vol. 25, no. 1, 218. https://doi.org/10.1186/s13063-024-08037-5

TY - JOUR

T1 - Clinical statistical analysis plan for the ACCURE trial

T2 - the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial

AU - Visser, Eva

AU - Heuthorst, Lianne

AU - Pathmakanthan, Shri

AU - Bemelman, Willem A.

AU - D’Haens, Geert R.

AU - Handley, Kelly

AU - Fakis, Apostolos

AU - Pinkney, Thomas D.

AU - Buskens, Christianne J.

AU - Dijkgraaf, Marcel G. W.

N1 - Funding: The Dutch arm of this investigator-initiated study was funded by a grant from the charity fund: Nuts-Ohra (FNO 1202-008). The ACCURE-UK 2 was funded by the Efficacy and Mechanism Evaluation Programme branch of the National Institute for Health Research (IRAS project ID: 254954). The funders had no role in designing the study and data collection nor will they influence the analysis and writing process of the manuscript.

PY - 2024/3/26

Y1 - 2024/3/26

N2 - 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.

AB - 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.

KW - Appendectomy

KW - Ulcerative colitis

KW - Disease recurrence

KW - Inflammatory bowel disease

KW - Statistical analysis plan

U2 - 10.1186/s13063-024-08037-5

DO - 10.1186/s13063-024-08037-5

M3 - Article

SN - 1745-6215

VL - 25

JO - Trials

JF - Trials

IS - 1

M1 - 218

ER -

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

Bibliographical note

Keywords

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