title: 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].
abstract: BACKGROUND
  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.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.There are no randomized trials on the use of this solution to prevent adhesions after ASIO operation in current medical literature.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.
  
  
  METHODS
  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.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.
  
  
  BACKGROUND
  ISRCTN22061989 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].
authors.affiliation: Transplant, General and Emergency Surgery DPT St. Orsola-Malpighi University Hospital Via Massarenti 9, 40138 Bologna, Italy. fcatena@aosp.bo.it
authors.forename: Fausto
authors.initials: F
authors.lastname: Catena
authors.forename: Luca
authors.initials: L
authors.lastname: Ansaloni
authors.forename: Augusto
authors.initials: A
authors.lastname: Lauro
authors.forename: Giorgio
authors.initials: G
authors.lastname: Ercolani
authors.forename: Luigi
authors.initials: L
authors.lastname: D'Alessandro
authors.forename: Antonio
authors.initials: A
authors.lastname: Pinna