The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)

Tjibbe J Gardenbroek; Thomas D Pinkney; Saloomeh Sahami; Dion G Morton; Christianne J Buskens; Cyriel Y Ponsioen; Pieter J Tanis; Mark Löwenberg; Gijs R van den Brink; Ivo A M J Broeders; Paul H J M Pullens; Tom Seerden; Maarten J Boom; Rosalie C Mallant-Hent; Robert E G J M Pierik; Juda Vecht; Meindert N Sosef; Annick B van Nunen; Bart A van Wagensveld; Pieter C F Stokkers; Michael F Gerhards; Jeroen M Jansen; Yair Acherman; Annekatrien C T M Depla; Guido H H Mannaerts; Rachel West; Tariq Iqbal; Shrikanth Pathmakanthan; Rebecca Howard; Laura Magill; Baljit Singh; Ye Htun Oo; Dmitri Negpodiev; Marcel G W Dijkgraaf; Geert R A M D'Haens; Willem A Bemelman

doi:10.1186/s12893-015-0017-1

The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)

Tjibbe J Gardenbroek, Thomas D Pinkney, Saloomeh Sahami, Dion G Morton, Christianne J Buskens, Cyriel Y Ponsioen, Pieter J Tanis, Mark Löwenberg, Gijs R van den Brink, Ivo A M J Broeders, Paul H J M Pullens, Tom Seerden, Maarten J Boom, Rosalie C Mallant-Hent, Robert E G J M Pierik, Juda Vecht, Meindert N Sosef, Annick B van Nunen, Bart A van Wagensveld, Pieter C F StokkersMichael F Gerhards, Jeroen M Jansen, Yair Acherman, Annekatrien C T M Depla, Guido H H Mannaerts, Rachel West, Tariq Iqbal, Shrikanth Pathmakanthan, Rebecca Howard, Laura Magill, Baljit Singh, Ye Htun Oo, Dmitri Negpodiev, Marcel G W Dijkgraaf, Geert R A M D'Haens, Willem A Bemelman

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Abstract

BACKGROUND: Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment.

METHODS/DESIGN: These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm.

DISCUSSION: The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course.

TRIAL REGISTRATION: NTR2883 ; ISRCTN56523019.

Original language	English
Pages (from-to)	1-7
Journal	JAMA Surgery
Volume	15
Issue number	30
DOIs	https://doi.org/10.1186/s12893-015-0017-1
Publication status	Published - 18 Mar 2015

Keywords

Inflammatory bowel disease
Ulcerative colitis
Appendectomy
Surgery
Disease course

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Erratum to: The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)
Gardenbroek, T. J., Pinkney, T. D., Sahami, S., Morton, D. G., Buskens, C. J., Ponsioen, C. Y., Tanis, P. J., Löwenberg, M., van den Brink, G. R., Broeders, I. A. M. J., Pullens, H. J. M., Seerden, T., Boom, M. J., Mallant-Hent, R. C., Pierik, R. E. G. J. M., Vecht, J., Sosef, M. N., van Nunen, A. B., van Wagensveld, B. A., Stokkers, P. C. F., & 16 othersGerhards, M. F., Jansen, J. M., Acherman, Y., Depla, A. C. T. M., Mannaerts, G. H. H., West, R., Iqbal, T., Pathmakanthan, S., Howard, R., Magill, L., Singh, B., Oo, Y. H., Negpodiev, D., Dijkgraaf, M. G. W., D'Haens, G. R. A. M. & Bemelman, W. A., 4 Jan 2016, In: JAMA Surgery. 16, 1, p. 1
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Gardenbroek, T. J., Pinkney, T. D., Sahami, S., Morton, D. G., Buskens, C. J., Ponsioen, C. Y., Tanis, P. J., Löwenberg, M., van den Brink, G. R., Broeders, I. A. M. J., Pullens, P. H. J. M., Seerden, T., Boom, M. J., Mallant-Hent, R. C., Pierik, R. E. G. J. M., Vecht, J., Sosef, M. N., van Nunen, A. B., van Wagensveld, B. A., ... Bemelman, W. A. (2015). The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019). JAMA Surgery, 15(30), 1-7. https://doi.org/10.1186/s12893-015-0017-1

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title = "The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)",

abstract = "BACKGROUND: Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment.METHODS/DESIGN: These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm.DISCUSSION: The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course.TRIAL REGISTRATION: NTR2883 ; ISRCTN56523019.",

keywords = "Inflammatory bowel disease, Ulcerative colitis, Appendectomy, Surgery , Disease course",

author = "Gardenbroek, {Tjibbe J} and Pinkney, {Thomas D} and Saloomeh Sahami and Morton, {Dion G} and Buskens, {Christianne J} and Ponsioen, {Cyriel Y} and Tanis, {Pieter J} and Mark L{\"o}wenberg and {van den Brink}, {Gijs R} and Broeders, {Ivo A M J} and Pullens, {Paul H J M} and Tom Seerden and Boom, {Maarten J} and Mallant-Hent, {Rosalie C} and Pierik, {Robert E G J M} and Juda Vecht and Sosef, {Meindert N} and {van Nunen}, {Annick B} and {van Wagensveld}, {Bart A} and Stokkers, {Pieter C F} and Gerhards, {Michael F} and Jansen, {Jeroen M} and Yair Acherman and Depla, {Annekatrien C T M} and Mannaerts, {Guido H H} and Rachel West and Tariq Iqbal and Shrikanth Pathmakanthan and Rebecca Howard and Laura Magill and Baljit Singh and Oo, {Ye Htun} and Dmitri Negpodiev and Dijkgraaf, {Marcel G W} and D'Haens, {Geert R A M} and Bemelman, {Willem A}",

year = "2015",

month = mar,

day = "18",

doi = "10.1186/s12893-015-0017-1",

language = "English",

volume = "15",

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journal = "JAMA Surgery",

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Gardenbroek, TJ, Pinkney, TD, Sahami, S, Morton, DG, Buskens, CJ, Ponsioen, CY, Tanis, PJ, Löwenberg, M, van den Brink, GR, Broeders, IAMJ, Pullens, PHJM, Seerden, T, Boom, MJ, Mallant-Hent, RC, Pierik, REGJM, Vecht, J, Sosef, MN, van Nunen, AB, van Wagensveld, BA, Stokkers, PCF, Gerhards, MF, Jansen, JM, Acherman, Y, Depla, ACTM, Mannaerts, GHH, West, R, Iqbal, T, Pathmakanthan, S, Howard, R, Magill, L, Singh, B, Oo, YH, Negpodiev, D, Dijkgraaf, MGW, D'Haens, GRAM & Bemelman, WA 2015, 'The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)', JAMA Surgery, vol. 15, no. 30, pp. 1-7. https://doi.org/10.1186/s12893-015-0017-1

The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019). / Gardenbroek, Tjibbe J; Pinkney, Thomas D; Sahami, Saloomeh et al.
In: JAMA Surgery, Vol. 15, No. 30, 18.03.2015, p. 1-7.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The ACCURE-trial

T2 - the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)

AU - Gardenbroek, Tjibbe J

AU - Pinkney, Thomas D

AU - Sahami, Saloomeh

AU - Morton, Dion G

AU - Buskens, Christianne J

AU - Ponsioen, Cyriel Y

AU - Tanis, Pieter J

AU - Löwenberg, Mark

AU - van den Brink, Gijs R

AU - Broeders, Ivo A M J

AU - Pullens, Paul H J M

AU - Seerden, Tom

AU - Boom, Maarten J

AU - Mallant-Hent, Rosalie C

AU - Pierik, Robert E G J M

AU - Vecht, Juda

AU - Sosef, Meindert N

AU - van Nunen, Annick B

AU - van Wagensveld, Bart A

AU - Stokkers, Pieter C F

AU - Gerhards, Michael F

AU - Jansen, Jeroen M

AU - Acherman, Yair

AU - Depla, Annekatrien C T M

AU - Mannaerts, Guido H H

AU - West, Rachel

AU - Iqbal, Tariq

AU - Pathmakanthan, Shrikanth

AU - Howard, Rebecca

AU - Magill, Laura

AU - Singh, Baljit

AU - Oo, Ye Htun

AU - Negpodiev, Dmitri

AU - Dijkgraaf, Marcel G W

AU - D'Haens, Geert R A M

AU - Bemelman, Willem A

PY - 2015/3/18

Y1 - 2015/3/18

N2 - BACKGROUND: Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment.METHODS/DESIGN: These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm.DISCUSSION: The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course.TRIAL REGISTRATION: NTR2883 ; ISRCTN56523019.

AB - BACKGROUND: Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment.METHODS/DESIGN: These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm.DISCUSSION: The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course.TRIAL REGISTRATION: NTR2883 ; ISRCTN56523019.

KW - Inflammatory bowel disease

KW - Ulcerative colitis

KW - Appendectomy

KW - Surgery

KW - Disease course

U2 - 10.1186/s12893-015-0017-1

DO - 10.1186/s12893-015-0017-1

M3 - Article

C2 - 25887789

SN - 2168-6254

VL - 15

SP - 1

EP - 7

JO - JAMA Surgery

JF - JAMA Surgery

IS - 30

ER -

Gardenbroek TJ, Pinkney TD, Sahami S, Morton DG, Buskens CJ, Ponsioen CY et al. The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019). JAMA Surgery. 2015 Mar 18;15(30):1-7. doi: 10.1186/s12893-015-0017-1

The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)

Abstract

Keywords

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Research output

Erratum to: The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)

Cite this