Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.
Br J Surg. 2015 Jun;102(7):726-34. doi: 10.1002/bjs.9776. Epub 2015 Apr 2.
The contribution of animal research to a reduction in clinical intestinal anastomotic leakage is unknown, despite numerous experimental studies. In view of the current societal call to replace, reduce and refine animal experiments, this study examined the quality of animal research related to anastomotic healing and leakage.
Animal studies on intestinal anastomotic healing were retrieved systematically from PubMed and Embase. Study objective, conclusion and animal model were recorded. Reporting quality and internal validity (reporting of randomization and blinding) were assessed.
A total of 1342 studies were identified, with a rising publication rate. The objectives of most studies were therapeutic interventions (64·8 per cent) and identification of risk factors (27·5 per cent). Of 350 articles studying experimental therapies, 298 (85·1 per cent) reported a positive effect on anastomotic healing. On average, 44·7 per cent of relevant study characteristics were not reported, in particular details on anastomotic complications (31·6 per cent), use of antibiotics (75·7 per cent), sterile surgery (83·4 per cent) and postoperative analgesia (91·4 per cent). The proportion of studies with randomization, blinding of surgery and blinding of primary outcome assessment has increased in the past two decades but remains insufficient, being included in only 62·4, 4·9 and 8·5 per cent of publications respectively. Animal models varied widely in terms of species, method to compromise healing, intestinal segment and outcome measures used.
Animal research on anastomotic leakage is of poor quality and still increasing, contrary to societal aims. Reporting and study quality must improve if results are to impact on patients.
尽管有大量的实验研究,但动物研究对减少临床肠道吻合口漏的贡献尚不清楚。鉴于当前社会呼吁替代、减少和优化动物实验,本研究检查了与吻合口愈合和漏相关的动物研究的质量。
系统地从 PubMed 和 Embase 中检索了关于肠道吻合口愈合的动物研究。记录了研究目的、结论和动物模型。评估了报告质量和内部有效性(随机化和盲法报告)。
共确定了 1342 项研究,发表率呈上升趋势。大多数研究的目的是治疗干预(64.8%)和确定危险因素(27.5%)。在 350 项研究实验治疗的文章中,298 项(85.1%)报告对吻合口愈合有积极影响。平均而言,44.7%的相关研究特征未报告,特别是吻合口并发症的细节(31.6%)、抗生素的使用(75.7%)、无菌手术(83.4%)和术后镇痛(91.4%)。在过去的二十年中,随机化、手术盲法和主要结局评估盲法的研究比例有所增加,但仍不足,分别仅纳入出版物的 62.4%、4.9%和 8.5%。动物模型在物种、影响愈合的方法、肠段和使用的结局测量方面差异很大。
与社会目标相反,吻合口漏的动物研究质量较差且仍在增加。如果要将结果应用于患者,报告和研究质量必须提高。