Berrevoet F, Doerhoff C, Muysoms F, Hopson S, Muzi M G, Nienhuijs S, Kullman E, Tollens T, Schwartz M, Leblanc K, Velanovich V, Jørgensen L N
Department of General and Hepatopancreatobiliary Surgery, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.
Surgicare of Missouri, Jefferson City, MO, USA.
BMC Surg. 2019 Jul 16;19(1):93. doi: 10.1186/s12893-019-0555-z.
This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the Parietex™ Composite Ventral Patch (PCO-VP).
A prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed.
One hundred twenty-six subjects (110 with umbilical hernia and 16 with epigastric hernia) with a mean hernia diameter of 1.8 cm (0.4-4.0) were treated with PCO-VP. One hundred subjects completed the two-year study. Cumulative hernia recurrence was 3.0% (3/101; 95%CI: 0.0-6.3%) within 24 months. Median Numeric Rating Scale pain scores improved from 2 [0-10] at baseline to 0 [0-3] at 1 month (P < 0.001) and remained low at 24 months 0 [0-6] (P < 0.001). 99% (102/103) of the patients were satisfied with their repair at 24 months postoperative.
The use of PCO-VP to repair primary umbilical and epigastric defects yielded a low recurrence rate, low postoperative and chronic pain, and high satisfaction ratings, confirming that PCO-VP is effective for small ventral hernia repair in the two-year term after implantation.
The study was registered publically at clinicaltrials.gov ( NCT01848184 registered May 7, 2013).
本研究评估了使用Parietex™复合腹侧补片（PCO-VP）进行开放性腹侧原发性疝修补术患者两年随访的临床结果，包括安全性和复发情况。
对126例使用PCO-VP进行脐疝和上腹部疝开放性腹侧疝修补术的患者进行了一项前瞻性单臂多中心研究。
126例受试者（110例脐疝和16例上腹部疝），平均疝直径为1.8 cm（0.4 - 4.0），接受了PCO-VP治疗。100名受试者完成了两年的研究。24个月内累积疝复发率为3.0%（3/101；95%CI：0.0 - 6.3%）。数字评定量表疼痛评分中位数从基线时的2[0 - 10]改善到1个月时的0[0 - 3]（P < 0.001），并在24个月时保持在低水平0[0 - 6]（P < 0.001）。99%（102/103）的患者在术后24个月对其修补术感到满意。
使用PCO-VP修复原发性脐部和上腹部缺损复发率低、术后和慢性疼痛低且满意度高，证实PCO-VP在植入后两年内对小型腹侧疝修补有效。
该研究在clinicaltrials.gov上进行了公开注册（NCT01848184，于2013年5月7日注册）。
