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Randomized Controlled Trial
. 2024 Feb 26;24(1):71.
doi: 10.1186/s12893-024-02340-3.

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)

Anouck E G Haanappel #  1 , Vittoria Bellato #  2 , Christianne J Buskens  3 , Alessandro Armuzzi  4   5 , Jarmila D W van der Bilt  6 , Nanne K H de Boer  7 , Silvio Danese  8 , Eline M L van der Does de Willebois  3 , Marjolijn Duijvestein  9 , Daniëlle van der Horst  10 , Gianluca Pellino  11 , Milan C Richir  12 , Francesco Selvaggi  11 , Antonino Spinelli  4   5 , Andrea Vignali  13 , Riccardo Rosati  14 , Willem A Bemelman  15   16
Affiliations
Randomized Controlled Trial

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)

Anouck E G Haanappel et al. BMC Surg. .

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/ ).

Keywords: CD; Crohn’s disease; Endoscopic recurrence; Handsewn anastomosis; IBD; Ileocaecal resection; Ileocolic anastomosis; Kono-S; Stapled anastomosis; Surgical recurrence.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Handsewn end-to-end anastomosis
Fig. 2
Fig. 2
Handsewn Kono-S anastomosis
Fig. 3
Fig. 3
Stapled side to side anastomosis
Fig. 4
Fig. 4
a Endoscopic recurrence at the inlet of the side to side anastomosis. b macroscopic recurrence at the inlet of the anastomosis
See this image and copyright information in PMC

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