Division of General Surgery, Department of Surgery, C 225, Chandler Medical Center, University of Kentucky College of Medicine, 800 Rose Street, Lexington, KY, 40536, USA.
Surg Endosc. 2018 Apr;32(4):1689-1694. doi: 10.1007/s00464-017-5848-7. Epub 2017 Sep 15.
Biomaterial research has made available a biologically derived fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for use in ventral and incisional hernia repair (VIHR). This study evaluates outcomes of patients undergoing VIHR with P4HB mesh.
An IRB-approved prospective pilot study was conducted to assess clinical and quality of life (QOL) outcomes for patients undergoing VIHR with P4HB mesh. Perioperative characteristics were defined. Clinical outcomes, employment status, QOL using 12-item short form survey (SF-12), and pain assessments were followed for 24 months postoperatively.
31 patients underwent VIHR with bioresorbable mesh via a Rives-Stoppa approach with retrorectus mesh placement. The median patient age was 52 years, median body mass index was 33 kg/m, and just over half of the patients were female. Surgical site occurrences occurred in 19% of patients, most of which were seroma. Hernia recurrence rate was 0% (median follow-up = 414 days). Patients had significantly improved QOL at 24 months compared to baseline for SF-12 physical component summary and role emotional (p < 0.05).
Ventral hernia repair with P4HB bioresorbable mesh results in favorable outcomes. Early hernia recurrence was not identified among the patient cohort. Quality of life improvements were noted at 24 months versus baseline for this cohort of patients with bioresorbable mesh. Use of P4HB mesh for ventral hernia repair was found to be feasible in this patient population. (ClinicalTrials.gov Identifier: NCT01863030).
生物材料研究提供了一种生物衍生的完全可吸收的聚 4-羟基丁酸酯(P4HB)网片,可用于腹侧和切口疝修复(VIHR)。本研究评估了接受 P4HB 网片 VIHR 的患者的结果。
一项经机构审查委员会批准的前瞻性试点研究旨在评估接受 P4HB 网片 VIHR 的患者的临床和生活质量(QOL)结果。定义了围手术期特征。对临床结果、就业状况、使用 12 项简明健康调查问卷(SF-12)进行的 QOL 评估以及术后 24 个月的疼痛评估进行了随访。
31 例患者通过 Rives-Stoppa 入路和后腹膜网片置入接受生物可吸收网片 VIHR。患者的中位年龄为 52 岁,中位体重指数为 33kg/m,超过一半的患者为女性。19%的患者发生手术部位并发症,大多数为血清肿。疝复发率为 0%(中位随访时间=414 天)。与基线相比,患者在 24 个月时 SF-12 生理成分综合评分和角色情感评分显著改善(p<0.05)。
P4HB 生物可吸收网片 VIHR 结果良好。在患者队列中未发现早期疝复发。与基线相比,该生物可吸收网片患者队列在 24 个月时的生活质量得到改善。在该患者人群中,使用 P4HB 网片进行腹侧疝修复是可行的。(临床试验标识符:NCT01863030)。