TY - JOUR
T1 - Optimising surgical anastomosis in ileocolic resection for Crohn’s disease with respect to recurrence and functionality
T2 - two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES)
AU - Haanappel, Anouck E. G.
AU - Bellato, Vittoria
AU - Buskens, Christianne J.
AU - Armuzzi, Alessandro
AU - van der Bilt, Jarmila D. W.
AU - de Boer, Nanne K. H.
AU - Danese, Silvio
AU - van der Does de Willebois, Eline M. L.
AU - Duijvestein, Marjolijn
AU - van der Horst, Daniëlle
AU - Pellino, Gianluca
AU - Richir, Milan C.
AU - Selvaggi, Francesco
AU - Spinelli, Antonino
AU - Vignali, Andrea
AU - Rosati, Riccardo
AU - Bemelman, Willem A.
N1 - Publisher Copyright: © The Author(s) 2024.
PY - 2024/12/1
Y1 - 2024/12/1
N2 - 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/).
AB - 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/).
KW - CD
KW - Crohn’s disease
KW - Endoscopic recurrence
KW - Handsewn anastomosis
KW - IBD
KW - Ileocaecal resection
KW - Ileocolic anastomosis
KW - Kono-S
KW - Stapled anastomosis
KW - Surgical recurrence
UR - http://www.scopus.com/inward/record.url?scp=85186174805&partnerID=8YFLogxK
U2 - 10.1186/s12893-024-02340-3
DO - 10.1186/s12893-024-02340-3
M3 - Article
C2 - 38408943
SN - 1471-2482
VL - 24
JO - BMC Surgery
JF - BMC Surgery
IS - 1
M1 - 71
ER -