RESUMO
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/ ).
Assuntos
Doença de Crohn , Humanos , Anastomose Cirúrgica/métodos , Colo/cirurgia , Doença de Crohn/cirurgia , Íleo/cirurgia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Adolescente , AdultoRESUMO
Postponement of surgical inflammatory bowel disease (IBD) care may lead to disease progression. This study aims to determine the influence of delayed surgical IBD procedures on clinical outcomes. This multicenter retrospective cohort study included IBD patients who underwent a surgical procedure during the Coronavirus disease 2019 (COVID-19) pandemic from March 16, 2020, to December 31, 2020, and were compared to a pre-COVID-19 cohort. The primary endpoint was determining the number of (major) postoperative complications. Secondary endpoints were the time interval between surgical indication and performance of the surgical procedure and the risk factors of postoperative complications using multivariate analysis. Eighty-one IBD patients who underwent a surgical procedure were included. The median time interval between surgical indication and performance of the surgical procedure did not differ between the COVID-19 and pre-COVID-19 cohorts (34 vs. 33.5 days, p = 0.867). Multivariate analysis revealed a longer time interval between surgical indication and surgical procedure significantly correlated with the risk of developing postoperative complications [odds ratio (OR) 1.03, p = 0.034]. Moreover, previous surgery was identified as an independent predictor (OR 4.25, p = 0.018) for an increased risk of developing major postoperative complications. There was no significant surgical delay for patients with IBD in the COVID-19 pandemic cohort compared to the pre-pandemic cohort. However, a longer time interval between surgical indication and surgical procedure significantly correlated with the risk of developing postoperative complications. In the event of future scarcity in healthcare, efforts should be made to continue surgical procedures in IBD patients.