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This study compares the efficacy of early surgical with medical treatment in patients with ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up pharmacological therapy.
Surgical therapy is currently indicated for Crohn's disease (CD) patients after conservative treatment becomes ineffective. The principles of so-called step-up therapy (STUP) where surgery represents the last therapeutical option are still followed.
Early surgical intervention (Early Surgery - ES) can be an alternative even in patients with uncomplicated type of CD before all medical therapy is used (Top-down approach). Limited resection under these conditions will lead to immediate remission. Moreover, laparoscopic ileocaecal resection is safe with low morbidity and regarding potential complications of step-up treatment might be beneficial for the patient.
Before wide introduction of ES approach into clinical practice, it is necessary to perform a randomized trial comparing early resection with the standard step-up medical therapy.
The potential effect of early, intensive therapy (ileocaecal resection) on biological behavior of the disease has not been studied that is why patients with uncomplicated ileocaecal form are the most suitable for such a trial. Significant number of these patients will indeed progress into more unfavorable course of the disease (relapse, complicated form, early recurrence).
Other potential benefit of early resection is the extended period without necessary medication. Even pharmacological recurrence prevention is not needed after surgery in uncomplicated CD patient if other risk factors are excluded. Rapid remission induced by surgery can lead to faster improvement of quality of life than long-term medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Surgery - ES | Experimental | Early laparoscopic ileocaecal resection |
|
| Step-up therapy - STUP | No Intervention | Treatment with step-up conservative approach according to good clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ileocaecal resection | Procedure | laparoscopic ileocaecal resection with primary anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic remission | The rate of endoscopic remission defined as Rutgeerts score ≤ 1 and SES-CD = 0 in early surgery and standard step-up therapy group respectively | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| QoL | Quality of life measured by IBDQ, IBD Disability index | 24 months |
| Clinical remission | Clinical remission defined by Crohn's disease activity index < 150 |
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Inclusion criteria
Exclusion Criteria:
Other exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ondrej Ryska, Dr, PhD | Contact | 606254686 | 00420 | ondrejryska@centrum.cz |
| Name | Affiliation | Role |
|---|---|---|
| Ondrej Ryska, Dr, PhD | Section of IBD surgery - Czech Surgical Society | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Hospital Brno | Brno | 625 00 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17206705 | Background | Jess T, Riis L, Vind I, Winther KV, Borg S, Binder V, Langholz E, Thomsen OO, Munkholm P. Changes in clinical characteristics, course, and prognosis of inflammatory bowel disease during the last 5 decades: a population-based study from Copenhagen, Denmark. Inflamm Bowel Dis. 2007 Apr;13(4):481-9. doi: 10.1002/ibd.20036. | |
| 19832727 |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 24 months |
| Drug consumption | Overall drug consumption (corticosteroids, antibiotics, immunomodulators, biologic therapy) | 24 months |
| Hospital Ceske Budejovice | České Budějovice | 370 01 | Czechia |
|
| Horovice Hospital | Hořovice | 26831 | Czechia |
|
| Universitiy Hospital Hradec Kralove | Hradec Králové | 50005 | Czechia |
|
| Hospital Jihlava | Jihlava | 586 33 | Czechia |
|
| Hospital Liberec | Liberec | 460 63 | Czechia |
|
| Vitkovice Hospital | Ostrava - Vitkovice | 703 84 | Czechia |
| University Hospital in Pilsen | Pilsen | 323 18 | Czechia |
|
| Royal Vinohrady University Hospital | Prague | 100 34 | Czechia |
|
| Institute for Clinical and Experimental Medicine | Prague | 140 21 | Czechia |
|
| Na Homolce Hospital | Prague | 150 00 | Czechia |
|
| ISCARE | Prague | 170 00 | Czechia |
|
| Domenech E, Zabana Y, Garcia-Planella E, Lopez San Roman A, Nos P, Ginard D, Gordillo J, Martinez-Silva F, Beltran B, Manosa M, Cabre E, Gassull MA. Clinical outcome of newly diagnosed Crohn's disease: a comparative, retrospective study before and after infliximab availability. Aliment Pharmacol Ther. 2010 Jan 15;31(2):233-9. doi: 10.1111/j.1365-2036.2009.04170.x. Epub 2009 Oct 13. |
| 15647188 | Background | Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. doi: 10.1136/gut.2004.045294. |
| 24282358 | Background | Golovics PA, Lakatos L, Nagy A, Pandur T, Szita I, Balogh M, Molnar C, Komaromi E, Lovasz BD, Mandel M, Veres G, Kiss LS, Vegh Z, Lakatos PL. Is early limited surgery associated with a more benign disease course in Crohn's disease? World J Gastroenterol. 2013 Nov 21;19(43):7701-10. doi: 10.3748/wjg.v19.i43.7701. |
| 18721465 | Background | Eshuis EJ, Bemelman WA, van Bodegraven AA, Sprangers MA, Bossuyt PM, van Milligen de Wit AW, Crolla RM, Cahen DL, Oostenbrug LE, Sosef MN, Voorburg AM, Davids PH, van der Woude CJ, Lange J, Mallant RC, Boom MJ, Lieverse RJ, van der Zaag ES, Houben MH, Vecht J, Pierik RE, van Ditzhuijsen TJ, Prins HA, Marsman WA, Stockmann HB, Brink MA, Consten EC, van der Werf SD, Marinelli AW, Jansen JM, Gerhards MF, Bolwerk CJ, Stassen LP, Spanier BW, Bilgen EJ, van Berkel AM, Cense HA, van Heukelem HA, van de Laar A, Slot WB, Eijsbouts QA, van Ooteghem NA, van Wagensveld B, van den Brande JM, van Geloven AA, Bruin KF, Maring JK, Oldenburg B, van Hillegersberg R, de Jong DJ, Bleichrodt R, van der Peet DL, Dekkers PE, Goei TH, Stokkers PC. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial). BMC Surg. 2008 Aug 22;8:15. doi: 10.1186/1471-2482-8-15. |
| 2394349 | Background | Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn's disease. Gastroenterology. 1990 Oct;99(4):956-63. doi: 10.1016/0016-5085(90)90613-6. |
| 21646246 | Background | Peyrin-Biroulet L, Cieza A, Sandborn WJ, Coenen M, Chowers Y, Hibi T, Kostanjsek N, Stucki G, Colombel JF; International Programme to Develop New Indexes for Crohn's Disease (IPNIC) group. Development of the first disability index for inflammatory bowel disease based on the international classification of functioning, disability and health. Gut. 2012 Feb;61(2):241-7. doi: 10.1136/gutjnl-2011-300049. Epub 2011 Jun 5. |
| 21122489 | Background | Dignass A, Van Assche G, Lindsay JO, Lemann M, Soderholm J, Colombel JF, Danese S, D'Hoore A, Gassull M, Gomollon F, Hommes DW, Michetti P, O'Morain C, Oresland T, Windsor A, Stange EF, Travis SP; European Crohn's and Colitis Organisation (ECCO). The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Current management. J Crohns Colitis. 2010 Feb;4(1):28-62. doi: 10.1016/j.crohns.2009.12.002. Epub 2010 Jan 15. No abstract available. |
| 16432345 | Background | Maartense S, Dunker MS, Slors JF, Cuesta MA, Pierik EG, Gouma DJ, Hommes DW, Sprangers MA, Bemelman WA. Laparoscopic-assisted versus open ileocolic resection for Crohn's disease: a randomized trial. Ann Surg. 2006 Feb;243(2):143-9; discussion 150-3. doi: 10.1097/01.sla.0000197318.37459.ec. |
| 17848181 | Result | Aratari A, Papi C, Leandro G, Viscido A, Capurso L, Caprilli R. Early versus late surgery for ileo-caecal Crohn's disease. Aliment Pharmacol Ther. 2007 Nov 15;26(10):1303-12. doi: 10.1111/j.1365-2036.2007.03515.x. Epub 2007 Sep 10. |
| D007410 | Intestinal Diseases |