Rosen Michael J, Bauer Joel J, Harmaty Marco, Carbonell Alfredo M, Cobb William S, Matthews Brent, Goldblatt Matthew I, Selzer Don J, Poulose Benjamin K, Hansson Bibi M E, Rosman Camiel, Chao James J, Jacobsen Garth R
*Department of General Surgery, Cleveland Clinic Foundation, Cleveland, OH †Department of Surgery, Mount Sinai School of Medicine, New York, NY ‡Division of Minimal Access and Bariatric Surgery, Greenville Health System, Greenville, SC §Department of Surgery, Carolinas Medical Center, Charlotte, NC ¶Department of Surgery, Medical College of Wisconsin, Milwaukee, WI ||Department of Surgery, Indiana University School of Medicine, Indianapolis, IN **Division of General Surgery, Vanderbilt University Medical Center, Nashville, TN ††Department of Surgery, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands ‡‡Oasis MD Lifestyle Healthcare, San Diego, CA §§Department of Surgery, University California, San Diego School of Medicine, San Diego, CA.
Ann Surg. 2017 Jan;265(1):205-211. doi: 10.1097/SLA.0000000000001601.
The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months.
CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates.
Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests.
Patients had a mean age of 58 years, body mass index of 28 kg/m, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ≤ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05).
In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.
本研究旨在评估生物合成可吸收补片在24个月内对一期污染性（美国疾病控制中心II级和III级）腹正中疝（CVH）修复的效果。
CVH术后感染风险增加。使用合成或生物补片修复CVH已报道有慢性生物材料感染和高疝复发率。
手术野污染或清洁-污染且疝缺损至少9厘米的患者接受生物合成补片（开放、腹膜前、腹直肌后或腹腔内）修复并进行筋膜闭合（n = 104）。终点指标包括24个月时疝复发和术后伤口感染率的总体Kaplan-Meier估计值，以及EQ-5D和简短健康调查问卷12项（SF-12）。对意向性治疗人群进行分析，并使用配对t检验评估健康结局指标。
患者平均年龄58岁，体重指数为28 kg/m，77%的患者伤口污染，84%的患者完成了24个月的随访。同期手术包括瘘管拆除（n = 24）或取出先前放置的感染补片（n = 29）。疝复发率为17%（n = 16）。在CVH修复时，腹腔内放置生物合成补片显著增加了复发风险（P≤0.04）。手术部位感染（19/104）导致更高的复发风险（P < 0.01）。24个月时的平均EQ-5D（指数和视觉模拟评分）以及SF-12身体成分和心理评分较基线有所改善（P < 0.05）。
在这项前瞻性纵向研究中，生物合成可吸收补片在CVH修复患者的长期复发和生活质量方面显示出疗效，并为这些复杂情况下的生物补片和永久性合成补片提供了一种替代选择。
