Seefeldt C S, Meyer J S, Knievel J, Rieger A, Geißen R, Lefering R, Heiss M M
Department of Visceral, Vascular and Transplant Surgery/Chair of Surgery of the University of Witten-Herdecke, Krankenhaus Merheim, Kliniken der Stadt Köln, Ostmerheimer Straße. 200, 51109, Köln, Germany.
Institut für Forschung in der Operativen Medizin der Universität Witten/Herdecke, Ostmerheimer Straße 200, Haus 38, 51109, Köln, Germany.
Trials. 2019 Jan 16;20(1):55. doi: 10.1186/s13063-018-3122-5.
Inguinal hernia repair is one of the most common surgical operations globally; more than 20 million groin herniae are repaired annually worldwide. Recurrence after an inguinal hernia operation is a considerable clinical problem. Another remaining problem after hernia surgery is the occurrence of chronic pain. Up to now, the use of synthetic meshes is the standard procedure, but there is increasing evidence that biological meshes could be advantageous concerning the occurrence of chronic pain due to different postoperative remodeling, without the disadvantages of a life-long implant. We hypothesize that the use of a biological mesh reduces postoperative pain without being inferior in terms of recurrence rate compared with a synthetic mesh.
METHODS/DESIGN: The trial compares possible the advantages of biological matrices to synthetic meshes in laparo-endoscopic inguinal hernia repair. Four hundred and ninety-six patients with primary bilateral inguinal herniae in 20 German hernia centers will be enrolled. Biological mesh is used for one of the bilateral herniae, the other side will be operated on with a synthetic mesh. Randomization will preset which side is repaired with which material and trial participants will not be informed about the location of each mesh type. The primary endpoints will be intensity of postoperative local pain and the incidence of recurrent hernia after 2 years.
There is no reasonably sized trial that assesses the use of biological meshes in laparo-endoscopic inguinal hernia repair. Our self-controlled trial design allows a direct comparison of the two meshes with very few confounding factors as well as minimizing the exclusion criteria. As we compare CE-certified medical devices in their designated indication the medical risk is not different compared to routine clinical care. Due to the common nature of bilateral inguinal hernia, a high recruitment rate is achievable. Because guidelines for hernia repair have stressed the need for reliable data on the already frequent use of biological meshes, we can expect our trial to have a direct implication on hernia-repair standards.
German Clinical Trials Register, ID: DRKS00010178 . Registered on 16.June.2016. BIOLAP underwent full external peer review as part of the funding process with the German Research Foundation.
腹股沟疝修补术是全球最常见的外科手术之一；全球每年有超过2000万例腹股沟疝得到修补。腹股沟疝手术后的复发是一个相当严重的临床问题。疝手术后另一个遗留问题是慢性疼痛的发生。到目前为止，使用合成补片是标准手术，但越来越多的证据表明，由于不同的术后重塑，生物补片在慢性疼痛的发生方面可能具有优势，且没有终身植入的缺点。我们假设，与合成补片相比，使用生物补片可减轻术后疼痛，且在复发率方面不逊色。
方法/设计：该试验比较了在腹腔镜腹股沟疝修补术中生物基质与合成补片的可能优势。德国20个疝中心的496例原发性双侧腹股沟疝患者将被纳入研究。双侧疝中的一侧使用生物补片，另一侧使用合成补片进行手术。随机分组将预先设定哪一侧使用哪种材料进行修补，试验参与者不会被告知每种补片类型的位置。主要终点将是术后局部疼痛强度和2年后复发疝的发生率。
尚无评估生物补片在腹腔镜腹股沟疝修补术中应用的合理规模试验。我们的自身对照试验设计允许在极少混杂因素的情况下对两种补片进行直接比较，并尽量减少排除标准。由于我们在指定适应症中比较CE认证的医疗器械，与常规临床护理相比，医疗风险并无差异。由于双侧腹股沟疝的普遍性，可以实现较高的招募率。由于疝修补指南强调需要关于生物补片频繁使用的可靠数据，我们预计我们的试验将对疝修补标准产生直接影响。
德国临床试验注册中心，ID：DRKS00010178。于2016年6月16日注册。BIOLAP作为德国研究基金会资助过程的一部分，接受了全面的外部同行评审。
