Abstract Background Crohn's disease presents a persistent challenge, particularly concerning disease recurrence in patients after previous intestinal resection. This recurrence often necessitates additional medical treatment or surgery, imposing a substantial burden on patients, healthcare systems, and society. New research suggest that an extended mesenteric resection can reduce the risk of recurrence at the anastomotic site. The EXCEED project aims to investigate the mesentery's influence on disease recurrence in Crohn's disease, guided by emerging evidence indicating that incorporating the mesentery during ileocecal resections can markedly diminish recurrence rates. Methods/design The EXCEED study is a blinded multicenter randomized controlled clinical trial involving 208 patients. Patients will undergo randomization into two groups: Group A, the treatment group, will receive extended mesenteric resection, while Group B, the control group, will undergo the standard resection with the mesentery largely preserved. Stratification will occur based on preoperative medicinal treatment categories (none, immunological, biological) and the treatment facility at the time of inclusion. This randomized controlled trial will incorporate blinding procedures, with the understanding that due to the nature of this interventional surgical study, the operating surgeon cannot be blinded. The primary endpoint of this study is endoscopic signs of recurrence, defined as a modified Rutgeerts score >i2a, at the 12-month follow-up ileo-colonoscopy. Secondary endpoints include clinical recurrence at 6 and 12 months, as well as recurrence at 3 and 5 years postoperatively, evaluated through chart review Tertiary endpoints are the impact of disease severity at the time of operation, according to the Montreal classification, on recurrence rates. Impact of biological treatment on recurrence rates. Postoperative complications burden according to the Comprehensive Complication Index (CCI). Patient reported outcome through questionnaires (5Q-5D-5L and SIBDQ) and cost-effectiveness analysis. Discussion This study addresses a critical gap in Crohn's disease literature, aiming to provide evidence on the impact of extended mesenteric excision in preventing disease recurrence, thereby contributing to enhanced patient outcomes. Trial registration This study is registered at ClinicalTrials.gov (ID NCT06324838) 04/02/2024.
Bælum et al. (Mon,) studied this question.