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].
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].
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DOI：
10.1186/1745-6215-9-74
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发表时间：
2008-12-18
期刊：
影响因子：
2.5
通讯作者：
Pinna, Antonio
中科院分区：
文献类型：
--
作者：
Catena, Fausto;Ansaloni, Luca;Lauro, Augusto;Ercolani, Giorgio;D'Alessandro, Luigi;Pinna, Antonio
粘连性小肠闭塞[ASIO]是入院的重要原因，给全球医疗保健系统带来了巨大负担。通常情况下，ASIO与显著的发病率和死亡率相关。艾考糊精4%溶液[Adept，Shire Pharmaceuticals，UK]是一种高分子量α-1，4葡萄糖聚合物，在欧洲获批用作术中灌洗和术后滴注，以减少术后腹腔内粘连的发生。目前的医学文献中没有关于使用该溶液预防ASIO术后粘连的随机试验。本临床研究评价了4%艾考糊精降低ASIO腹部手术后患者粘连发生率、范围和严重程度的安全性和有效性。本研究项目是一项前瞻性、随机对照研究，在圣奥尔索拉-马尔皮基大学医院[博洛尼亚，意大利]的移植、普通和急诊外科进行。本研究的设计和实施符合药物临床试验质量管理规范的原则。本研究比较了4%艾考糊精与未接受抗粘连治疗的对照组的结果。本随机研究采用双盲程序评价疗效终点。换句话说，指定不知道分配给患者的治疗的第三方人员评估粘连形成。ISRCTN 22061989关于粘连性小肠梗阻剖腹术后4%艾考糊精溶液预防术后腹腔粘连的前瞻性对照随机试验[POPA研究：预防术后粘连]
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. 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. 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]
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影响因子：
5.2
作者：
Ray, NF;Denton, WG;Perry, S
通讯作者：
Perry, S
影响因子：
6.1
作者：
diZerega, GS;Verco, SJS;Brown, CB
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6.1
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作者：
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