Assesses SEAL-G for reducing anastomotic leaks in emergency GI patients, suggesting improved outcomes.
<ns3:p>Background Emergency abdominal surgery is associated with high morbidity and mortality, with anastomotic leak (AL) remaining a major postoperative complication. AL occurs in approximately 10% of emergency gastrointestinal (GI) anastomoses, increasing mortality threefold and often leading to reoperation, stoma formation, and prolonged hospitalisation. SEAL-G is a novel, fully synthetic, in-situ forming alginate hydrogel designed to reinforce GI anastomoses. It adheres mechanically without heat generation, provides flexibility compatible with bowel tissue, and is absorbed over several months. Pre-clinical data show SEAL-G potentially reduces severe leaks which in a clinical environment would warrant return to theatre. However, its efficacy in true life clinical settings and emergency GI surgery remains unstudied. Aims This study aims to (1) assess clinical outcomes following SEAL-G use in emergency GI anastomoses, (2) compare outcomes with matched controls without SEAL-G, and (3) evaluate surgeons’ perspectives on SEAL-G and other anastomotic leak preventive measures and its influence on decision-making regarding anastomosis versus stoma formation. Methods A multicentre, non-interventional, observational audit will be conducted across NHS and other hospitals where SEAL-G is available. Eligible patients (>16 years) undergoing emergency GI anastomosis will be included. Patients who underwent the anastomosis with the reinforcement of SEAL-G sealant will be compared with current or historical controls. Data on demographics, peri-operative variables, and post-operative outcomes—particularly AL rates—will be collected and compared with historical or contemporaneous controls using propensity matching. Additionally, a mixed-methods qualitative evaluation (surveys, interviews, focus groups, and ethnographic observation) will explore surgeons’ experiences, perceived safety, usability, and decision-making influences. A target of 160 patients will allow robust assessment across a heterogeneous emergency surgical population.</ns3:p>
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Chitul et al. (2026) studied this question.
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