Nieuwenhuizen Jeroen, Eker Hasan H, Timmermans Lucas, Hop Wim C J, Kleinrensink Gert-Jan, Jeekel Johannes, Lange Johan F
Department of Surgery, Erasmus MC, Rotterdam, The Netherlands.
BMC Surg. 2013 Oct 28;13:48. doi: 10.1186/1471-2482-13-48.
Incisional hernia is the most frequently seen long term complication after laparotomy causing much morbidity and even mortality. The overall incidence remains 11-20%, despite studies attempting to optimize closing techniques. Two patient groups, patients with abdominal aortic aneurysm and obese patients, have a risk for incisional hernia after laparotomy of more than 30%. These patients might benefit from mesh augmented midline closure as a means to reduce incisional hernia incidence.
METHODS/DESIGN: The PRImary Mesh Closure of Abdominal Midline Wound (PRIMA) trial is a double-blinded international multicenter randomized controlled trial comparing running slowly absorbable suture closure with the same closure augmented with a sublay or onlay mesh. Primary endpoint will be incisional hernia incidence 2 years postoperatively. Secondary outcomes will be postoperative complications, pain, quality of life and cost effectiveness.A total of 460 patients will be included in three arms of the study and randomized between running suture closure, onlay mesh closure or sublay mesh closure. Follow-up will be at 1, 3, 12 and 24 months with ultrasound imaging performed at 6 and 24 months to objectify the presence of incisional hernia. Patients, investigators and radiologists will be blinded throughout the whole follow up.
The use of prosthetic mesh has proven effective and safe in incisional hernia surgery however its use in a prophylactic manner has yet to be properly investigated. The PRIMA trial will provide level 1b evidence whether mesh augmented midline abdominal closure reduces incisional hernia incidence in high risk groups.
Clinical trial.gov NCT00761475.
切口疝是剖腹手术后最常见的远期并发症，会导致较高的发病率甚至死亡率。尽管有研究试图优化缝合技术，但总体发病率仍为11%-20%。两组患者，即腹主动脉瘤患者和肥胖患者，剖腹手术后发生切口疝的风险超过30%。这些患者可能会从使用补片加强中线缝合中获益，以此降低切口疝的发生率。
方法/设计：腹部中线伤口初次补片缝合（PRIMA）试验是一项双盲国际多中心随机对照试验，比较连续缓慢可吸收缝线缝合与采用腹膜前或腹膜上补片加强的相同缝合方式。主要终点是术后2年的切口疝发生率。次要结局包括术后并发症、疼痛、生活质量和成本效益。该研究的三个组将共纳入460例患者，并随机分为连续缝线缝合组、腹膜上补片缝合组或腹膜前补片缝合组。随访时间为1、3、12和24个月，在6个月和24个月时进行超声成像，以确定切口疝的存在。在整个随访过程中，患者、研究人员和放射科医生都将处于盲态。
在切口疝手术中，人工补片的使用已被证明有效且安全，但其预防性使用尚未得到充分研究。PRIMA试验将提供1b级证据，证明补片加强的腹部中线缝合是否能降低高危人群的切口疝发生率。
Clinical trial.gov NCT00761475。
