Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman J P, Deigaard S, Winther D, Errebo M B, Therkildsen R, Hauge D, Sørensen F S, Bjerg J, Rosenberg J
Department of Surgery, Center for Perioperative Optimization, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, 2730 Herlev,, Copenhagen, Denmark.
Department of Surgery, Horsens Hospital, Horsens, Denmark.
Hernia. 2015 Dec;19(6):871-7. doi: 10.1007/s10029-015-1428-8. Epub 2015 Oct 7.
Because of the high number of patients with chronic pain following inguinal hernia repair, a new, simple and safe method of repair is needed. Onstep is a new type of inguinal hernia repair that might be able to reduce postoperative acute and chronic pain. The aim of this study was to investigate if there were differences in early postoperative pain during the first 10 days between the Onstep and the Lichtenstein technique.
This was a double-blinded, randomized clinical trial conducted in five surgical departments in Denmark, from April 2013 to June 2014. Eligible participants for this study were male patients, >18 years, with a primary inguinal hernia. Experimental treatment in this study was the Onstep technique, which was compared with the Lichtenstein repair. Primary outcome was postoperative pain during the first 10 days following surgery. Secondary outcomes included duration of surgery, period for return to normal daily activities (days), and recurrence. Randomization was done in blocks and stratified on centers. Participants and study personnel handling questionnaires and analysis were blinded to the allocation.
In total, 290 participants were randomized. We found no significant differences between the groups regarding early postoperative pain or minor postoperative complications. Four patients had a recurrence within the first 10 days of follow-up, one patient in the Lichtenstein group and three patients in the Onstep group, p = 0.30.
The Onstep technique for inguinal hernia repair was safe and had comparable results to the Lichtenstein repair regarding short-term pain and postoperative complications.
Clinicaltrials.gov (NCT01753219).
由于腹股沟疝修补术后慢性疼痛患者数量众多，需要一种新的、简单且安全的修补方法。Onstep是一种新型的腹股沟疝修补术，可能能够减少术后急性和慢性疼痛。本研究的目的是调查Onstep技术与Lichtenstein技术在术后前10天的早期术后疼痛方面是否存在差异。
这是一项双盲、随机临床试验，于2013年4月至2014年6月在丹麦的五个外科科室进行。本研究的合格参与者为年龄大于18岁的原发性腹股沟疝男性患者。本研究中的实验性治疗是Onstep技术，并与Lichtenstein修补术进行比较。主要结局是术后第10天内的术后疼痛。次要结局包括手术持续时间、恢复正常日常活动的时间（天）和复发情况。随机分组采用区组设计并按中心分层。处理问卷和分析的参与者及研究人员对分组情况不知情。
总共290名参与者被随机分组。我们发现两组在早期术后疼痛或轻微术后并发症方面没有显著差异。在随访的前10天内有4例患者复发，Lichtenstein组1例，Onstep组3例，p = 0.30。
Onstep腹股沟疝修补技术是安全的，在短期疼痛和术后并发症方面与Lichtenstein修补术效果相当。
Clinicaltrials.gov（NCT01753219）。
