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Title of Journal: J Gastrointest Surg

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Abbravation: Journal of Gastrointestinal Surgery

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Springer-Verlag

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DOI

10.1016/0926-6526(64)90065-5

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1873-4626

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POPA Study Prevention of Postoperative Abdomi

Authors: Fausto Catena Luca Ansaloni Salomone Di Saverio Antonio D Pinna On Behalf of the World Society of Emergency Surgery
Publish Date: 2011/11/04
Volume: 16, Issue: 2, Pages: 382-388
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Abstract

Adhesive small bowel obstruction ASBO is an important cause of hospital admission is associated with significant morbidity and mortality and therefore is a substantial burden for healthcare systems worldwide Icodextrin 4 solution Adept Shire Pharmaceuticals UK is a highmolecularweight a14 glucose polymer approved in Europe for use as intraoperative lavage and postoperative instillation to reduce the occurrence of postsurgery intraabdominal adhesions The present clinical study aimed to evaluate the safety and effectiveness of icodextrin 4 in decreasing the incidence extent and severity of adhesions in patients after abdominal surgery for ASBOThe study was a singlecenter prospective randomized investigation The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations Safety and efficacy of icodextrin 4 in the study group are compared to no antiadhesion treatment in a parallel control group with blinded evaluation of primary endpoints Primary endpoints are the evaluation of the therapeutic role of icodextrin 4 in reducing ASBO recurrence incidence and the need of laparotomies for ASBO recurrence as well as adhesion formation with evaluation of their incidence extent and severity A sum of 181 patients with ASBO and surgical indication to laparotomy were enrolled and randomized in two groups Patients were submitted to adhesiolysis with bowel resection if required with or without anastomosis The first group received traditional treatment control group whereas the second group was treated with the addition of icodextrin 4 solution before the abdominal closureNinetyone patients were randomized to have icodextrin 4 solution administered intraperitoneally and 90 patients were randomized to have the traditional treatment The two study groups were homogeneous regarding their baseline characteristics The ASBO recurrence rate was 219 2/91 in the icodextrin groups vs 1111 10/90 in the control group after a mean followup period of 414 months p  005 No differences were found in the need of laparotomies for ASBO recurrence in the studied groups The adhesion severity score seems lower in the group treated with the addition of icodextrin p = ns

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