A randomized controlled trial of 0.5% ferric hyaluronate gel (Intergel) in the prevention of adhesions following abdominal surgery
A randomized controlled trial of 0.5% ferric hyaluronate gel (Intergel) in the prevention of adhesions following abdominal surgery
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DOI：
10.1097/01.sla.0000207837.71831.a2
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发表时间：
2006-04-01
影响因子：
9
通讯作者：
Mustapha, N
中科院分区：
文献类型：
--
作者：
Tang, CL;Jayne, DG;Mustapha, N
前言：腹部手术后肠粘连是腹部手术的重要后遗症。Intergel是一种基于透明质酸的凝胶，在妇科手术缝合前添加到腹膜腔中可以减少术后粘连的发生率。这是一项评价Intergel在结直肠切除术中的有效性和安全性的随机对照试验。虽然该研究旨在招募200例患者的功效分析的基础上，招募暂停，因为在治疗group.Methods的发病率高：共32例患者被随机分配到任何Intergel治疗（治疗组）或无治疗（对照组）后，开放的腹部手术。主要终点包括粘连性梗阻的发生率、后续粘连松解术的需要以及伤口和吻合口并发症的发生率。次要终点包括生活质量评估。结果：17例患者被随机分配到治疗组，15例患者被随机分配到对照组。除治疗组1例外，所有患者均因良性或恶性疾病行结肠或直肠切除吻合术。观察到两组之间术后发病率的患者数量存在显著差异（治疗组为65%，对照组为27%，P = 0.031）。在治疗组中观察到吻合口裂开发生率较高（治疗组5例vs对照组1例，P = 0.178）和术后肠梗阻延长（治疗组10例vs对照组2例，P = 0.011）。治疗组在存在完整吻合的情况下发生1例腹膜炎。伤口并发症在治疗组中更常见，但未达到统计学显著性。结论：在打开胃肠道的腹部手术中使用Intergel导致术后并发症发生率高得不可接受。
Introduction: Intestinal adhesion following abdominal Surgery is a significant sequela to abdominal surgery. Intergel is a hyaluronate-based gel that reduces the incidence of postoperative adhesions when added to the peritoneal cavity before closure in gynecologic surgery. This is a randomized controlled trial evaluating the efficacy and safety of Intergel in colorectal resections. Although the study aimed to recruit 200 patients based on power analysis, recruitment was suspended because of the high morbidity in the treatment group.Methods: A total of 32 patients were randomized to either Intergel treatment (treatment group) or no treatment (control group) following open abdominal surgery. Primary endpoints included the incidence of adhesive obstruction, the need for subsequent adhesiolysis, and the incidence of wound and anastomotic complications. A secondary endpoint involved quality-of-life assessment.Results: Seventeen patients were randomized to the treatment group and 15 to the control group. All patients, except 1 in the treatment group, underwent resection and anastomosis of the colon or rectum for benign or malignant disease. A significant difference was observed in the number of patients with postoperative morbidities between the 2 groups (65% treatment group versus 27% control group, P = 0.031). There was a high rate of anastomotic dehiscence (5 treatment group versus I control group, P = 0.178) and prolonged postoperative ileus (10 treatment group versus 2 control group, P = 0.011) observed in treatment group. One case of peritonitis occurred in the treatment group in the presence of an intact anastomosis. Wound complications were more common in treatment group but failed to reach statistical significance.Conclusion: The use of Intergel in abdominal surgery where the gastrointestinal tract is opened leads to unacceptably high rates of postoperative complications.