Prospective controlled randomized trial on prevention of postoperative abdominal adhesions by Icodextrin 4% solution after laparotomic operation for small bowel obstruction caused by adherences [POPA study: Prevention of Postoperative Adhesions on behalf of the World Society of Emergency Surgery]

<p>Abstract</p> <p>Background</p> <p>Adhesive small intestine occlusion [ASIO] is an important cause of hospital admission placing a substantial burden on healthcare systems worldwide. Often times, ASIO is associated with significant morbidity and mortality.</p> <p>Icodextrin 4% solution [Adept, Shire Pharmaceuticals, UK] is a high-molecular-weight a-1,4 glucose polymer that is approved in Europe for use as an intra-operative lavage and a post-operative instillate to reduce the occurrence of post-surgery intra-abdominal adhesions.</p> <p>There are no randomized trials on the use of this solution to prevent adhesions after ASIO operation in current medical literature.</p> <p>The current clinical study evaluates the safety and effectiveness of Icodextrin 4% for decreasing the incidence, extent, and severity of adhesions in patients after abdominal surgery for ASIO.</p> <p>Design</p> <p>The study project is a prospective, randomized controlled investigation performed in the Department of Transplant, General and Emergency Surgery of St. Orsola-Malpighi University Hospital [Bologna, Italy]. The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations.</p> <p>The study compares the results of Icodextrin 4% against a control group who does not receive anti-adhesion treatment. This randomized study uses a double-blind procedure to evaluate efficacy end points. In other words, designated third party individuals who are unaware of the treatment assigned to the patients to assess adhesion formation.</p> <p>Trial Registration Number</p> <p>ISRCTN22061989</p> <p>Prospective controlled randomized trial on Prevention of Postoperative Abdominal Adhesions by Icodextrin 4% solution after laparotomic operation for small bowel obstruction caused by adherences</p> <p>[POPA study: Prevention of Postoperative Adhesions]</p