Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES)
Abstract Background The most common intestinal operation in Crohn’s disease (CD) is an ileocolic resection. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after rese...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | BMC Surgery |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12893-024-02340-3 |
| _version_ | 1797276054656647168 |
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| author | Anouck E. G. Haanappel Vittoria Bellato Christianne J. Buskens Alessandro Armuzzi Jarmila D. W. van der Bilt Nanne K. H. de Boer Silvio Danese Eline M. L. van der Does de Willebois Marjolijn Duijvestein Daniëlle van der Horst Gianluca Pellino Milan C. Richir Francesco Selvaggi Antonino Spinelli Andrea Vignali Riccardo Rosati Willem A. Bemelman |
| author_facet | Anouck E. G. Haanappel Vittoria Bellato Christianne J. Buskens Alessandro Armuzzi Jarmila D. W. van der Bilt Nanne K. H. de Boer Silvio Danese Eline M. L. van der Does de Willebois Marjolijn Duijvestein Daniëlle van der Horst Gianluca Pellino Milan C. Richir Francesco Selvaggi Antonino Spinelli Andrea Vignali Riccardo Rosati Willem A. Bemelman |
| author_sort | Anouck E. G. Haanappel |
| collection | DOAJ |
| description | Abstract Background The most common intestinal operation in Crohn’s disease (CD) is an ileocolic resection. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection for example, handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. The objective of the present study is to compare the three types of anastomoses with respect to endoscopic recurrence at 6 months, gastrointestinal function, and health care consumption. Methods This is a randomized controlled multicentre superiority trial, allocating patients either to side-to-side stapled anastomosis as advised in current guidelines or a handsewn anastomoses (an end-to-end or Kono-S). It is hypothesized that handsewn anastomoses do better than stapled, and end-to-end perform better than the saccular Kono-S. Two international studies with a similar setup will be conducted mainly in the Netherlands (End2End) and Italy (HAND2END). Patients diagnosed with CD, aged over 16 years in the Netherlands and 18 years in Italy requiring (re)resection of the (neo)terminal ileum are eligible. The first part of the study compares the two handsewn anastomoses with the stapled anastomosis. To detect a clinically relevant difference of 25% in endoscopic recurrence, a total of 165 patients will be needed in the Netherlands and 189 patients in Italy. Primary outcome is postoperative endoscopic recurrence (defined as Rutgeerts score ≥ i2b) at 6 months. Secondary outcomes are postoperative morbidity, gastrointestinal function, quality of life (QoL) and costs. Discussion The research question addresses a knowledge gap within the general practice elucidating which type of anastomosis is superior in terms of endoscopic and clinical recurrence, functionality, QoL and health care consumption. The results of the proposed study might change current practice in contrast to what is advised by the guidelines. Trial registration NCT05246917 for HAND2END and NCT05578235 for End2End ( http://www.clinicaltrials.gov/ ). |
| first_indexed | 2024-03-07T15:22:49Z |
| format | Article |
| id | doaj.art-4e61d168f22d4034899999783d93a241 |
| institution | Directory Open Access Journal |
| issn | 1471-2482 |
| language | English |
| last_indexed | 2024-03-07T15:22:49Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Surgery |
| spelling | doaj.art-4e61d168f22d4034899999783d93a2412024-03-05T17:30:50ZengBMCBMC Surgery1471-24822024-02-0124111010.1186/s12893-024-02340-3Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES)Anouck E. G. Haanappel0Vittoria Bellato1Christianne J. Buskens2Alessandro Armuzzi3Jarmila D. W. van der Bilt4Nanne K. H. de Boer5Silvio Danese6Eline M. L. van der Does de Willebois7Marjolijn Duijvestein8Daniëlle van der Horst9Gianluca Pellino10Milan C. Richir11Francesco Selvaggi12Antonino Spinelli13Andrea Vignali14Riccardo Rosati15Willem A. Bemelman16Department of Surgery, Amsterdam UMC, University of AmsterdamDepartment of Minimally invasive surgery, Tor Vergata University of RomeDepartment of Surgery, Amsterdam UMC, University of AmsterdamDepartment of Biomedical Sciences, Humanitas UniversityDepartment of Surgery, FlevoziekenhuisDepartment of Gastroenterology and Hepatology, AGEM Research Institute, Amsterdam University Medical Center, Vrije Universiteit AmsterdamGastroenterology and Gastrointestinal Endoscopy Unit, IRCCS Ospedale San Raffaele, Vita e Salute UniversityDepartment of Surgery, Amsterdam UMC, University of AmsterdamDepartment of Gastroenterology, Radboud University Medical CenterCrohn & Colitis NLDepartment of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”Department of Surgery, University Medical Center UtrechtDepartment of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”Department of Biomedical Sciences, Humanitas UniversityUnit of Coloproctology and IBD Surgery, IRCCS Ospedale San Raffaele, Vita e Salute UniversityDepartment of Gastrointestinal Surgery, IRCCS Ospedale San Raffaele, Vita e Salute UniversityDepartment of Surgery, Amsterdam UMC, University of AmsterdamAbstract Background The most common intestinal operation in Crohn’s disease (CD) is an ileocolic resection. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection for example, handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. The objective of the present study is to compare the three types of anastomoses with respect to endoscopic recurrence at 6 months, gastrointestinal function, and health care consumption. Methods This is a randomized controlled multicentre superiority trial, allocating patients either to side-to-side stapled anastomosis as advised in current guidelines or a handsewn anastomoses (an end-to-end or Kono-S). It is hypothesized that handsewn anastomoses do better than stapled, and end-to-end perform better than the saccular Kono-S. Two international studies with a similar setup will be conducted mainly in the Netherlands (End2End) and Italy (HAND2END). Patients diagnosed with CD, aged over 16 years in the Netherlands and 18 years in Italy requiring (re)resection of the (neo)terminal ileum are eligible. The first part of the study compares the two handsewn anastomoses with the stapled anastomosis. To detect a clinically relevant difference of 25% in endoscopic recurrence, a total of 165 patients will be needed in the Netherlands and 189 patients in Italy. Primary outcome is postoperative endoscopic recurrence (defined as Rutgeerts score ≥ i2b) at 6 months. Secondary outcomes are postoperative morbidity, gastrointestinal function, quality of life (QoL) and costs. Discussion The research question addresses a knowledge gap within the general practice elucidating which type of anastomosis is superior in terms of endoscopic and clinical recurrence, functionality, QoL and health care consumption. The results of the proposed study might change current practice in contrast to what is advised by the guidelines. Trial registration NCT05246917 for HAND2END and NCT05578235 for End2End ( http://www.clinicaltrials.gov/ ).https://doi.org/10.1186/s12893-024-02340-3IBDCrohn’s diseaseIleocaecal resectionIleocolic anastomosisCDHandsewn anastomosis |
| spellingShingle | Anouck E. G. Haanappel Vittoria Bellato Christianne J. Buskens Alessandro Armuzzi Jarmila D. W. van der Bilt Nanne K. H. de Boer Silvio Danese Eline M. L. van der Does de Willebois Marjolijn Duijvestein Daniëlle van der Horst Gianluca Pellino Milan C. Richir Francesco Selvaggi Antonino Spinelli Andrea Vignali Riccardo Rosati Willem A. Bemelman Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES) BMC Surgery IBD Crohn’s disease Ileocaecal resection Ileocolic anastomosis CD Handsewn anastomosis |
| title | Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES) |
| title_full | Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES) |
| title_fullStr | Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES) |
| title_full_unstemmed | Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES) |
| title_short | Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES) |
| title_sort | optimising surgical anastomosis in ileocolic resection for crohn s disease with respect to recurrence and functionality two international parallel randomized controlled trials comparing handsewn end to end or kono s to stapled anastomosis hand2end and the end2end studies |
| topic | IBD Crohn’s disease Ileocaecal resection Ileocolic anastomosis CD Handsewn anastomosis |
| url | https://doi.org/10.1186/s12893-024-02340-3 |
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