Extended mesenteric resection in Crohn's disease: EXCEED Study Protocol-a blinded multicenter randomized controlled
Jens Kristian Bælum1, Jacob Rosenberg2, Pernille Larsen3
1Department of Surgery, Odense University Hospital, Odense, Denmark. jens.kristian.baelum@rsyd.dk.
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. Emerging evidence suggests that extended mesenteric excision may reduce recurrence. The EXCEED study aims to investigate the mesentery's influence on disease recurrence in Crohn's disease.
Methods/Design:
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. Primary endpoint 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. Tertiary endpoints are; impact of disease severity at the time of operation, according to the Montreal classification, 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:
ClinicalTrials.gov NCT06324838. Registered on 04/02/2024.
