Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions: Protocol for a Multicentre, Non-Randomised, Clinical Effectiveness Trial (ADAPT).

INTRODUCTION:Anastomotic leakage (AL) after colorectal surgery is an impactful complication, associated with increased morbidity and reduced quality of life. The circular stapler commonly used for anterior resections (AR), introduces risks of cross-stapling, dog-ears, overcompression, and foreign body response, all associated with AL. An adaptive anastomosis technique eliminates these risk factors, potentially lowering the incidence of AL. METHODS:The ADAPT trial is an international multicentre, non-randomised, prospective clinical effectiveness trial evaluating the clinical safety and efficacy of the C-REX adaptive anastomosis in minimally invasive AR. 165 Patients with proximal rectum or sigmoid cancer, or premalignant lesions requiring AR will be enrolled throughout multiple European colorectal centres. An adaptive colorectal anastomosis will be constructed using the C-REX RectoAid Cath. The primary endpoint is 30-day AL rate. Secondary endpoints include 90-day AL, 1-year anastomotic integrity, intraoperative performance of the C-REX device, time to evacuation of the anastomotic ring, postoperative morbidity, functional outcomes, cost-effectiveness, and surgical quality assessment. CONCLUSION:The ADAPT trial will evaluate whether an adaptive anastomotic technique using the C-REX RectoAid Cath, designed to eliminate key technical risk factors, reduces AL after colorectal AR in an international multicentre setting. The findings could guide strategies to improve postoperative outcomes and reduce leakage-related morbidity. TRIAL REGISTRATION:ClinicalTrials.gov - NCTNCT07056374, July 2025.