可缓慢吸收的生物合成P4HB补片(Phasix)用于VHWG 3级切口疝修补的五年随访

Five-Year Follow-Up of a Slowly Resorbable Biosynthetic P4HB Mesh (Phasix) in VHWG Grade 3 Incisional Hernia Repair.

作者信息

Van den Dop L M, Van Rooijen M M J, Tollens T, Jørgensen L N, De Vries-Reilingh T S, Piessen G, Köckerling F, Miserez M, Dean M, Berrevoet F, Dousset B, Van Westreenen H L, Gossetti F, Tetteroo G W M, Koch A, Boomsma M F, Lange J F, Jeekel J

机构信息

From the Department of Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.

Department of Surgery, Imelda Hospital, Bonheiden, Belgium.

出版信息

Ann Surg Open. 2023 Nov 28;4(4):e366. doi: 10.1097/AS9.0000000000000366. eCollection 2023 Dec.

Abstract

OBJECTIVE

To assess the 5-year recurrence rate of incisional hernia repair in Ventral Hernia Working Group (VHWG) 3 hernia with a slowly resorbable mesh.

SUMMARY BACKGROUND DATA

Incisional hernia recurs frequently after initial repair. In potentially contaminated hernia, recurrences rise to 40%. Recently, the biosynthetic Phasix mesh has been developed that is resorbed in 12-18 months. Resorbable meshes might be a solution for incisional hernia repair to decrease short- and long-term (mesh) complications. However, long-term outcomes after resorption are scarce.

METHODS

Patients with VHWG grade 3 incisional midline hernia, who participated in the Phasix trial (Clinilcaltrials.gov: NCT02720042) were included by means of physical examination and computed tomography (CT). Primary outcome was hernia recurrence; secondary outcomes comprised of long-term mesh complications, reoperations, and abdominal wall pain [visual analogue score (VAS): 0-10].

RESULTS

In total, 61/84 (72.6%) patients were seen. Median follow-up time was 60.0 [interquartile range (IQR): 55-64] months. CT scan was made in 39 patients (68.4%). A recurrence rate of 15.9% (95% confidence interval: 6.9-24.8) was calculated after 5 years. Four new recurrences (6.6%) were found between 2 and 5 years. Two were asymptomatic. In total, 13/84 recurrences were found. No long-term mesh complications and/or interventions occurred. VAS scores were 0 (IQR: 0-2).

CONCLUSIONS

Hernia repair with Phasix mesh in high-risk patients (VHWG 3, body mass index >28) demonstrated a recurrence rate of 15.9%, low pain scores, no mesh-related complications or reoperations for chronic pain between the 2- and 5-year follow-up. Four new recurrences occurred, 2 were asymptomatic. The poly-4-hydroxybutyrate mesh is a safe mesh for hernia repair in VHWG 3 patients, which avoids long-term mesh complications like pain and mesh infection.

摘要

目的

评估使用可缓慢吸收补片修复腹侧疝工作组(VHWG)3级疝的5年复发率。

总结背景数据

切口疝初次修复后经常复发。在可能受污染的疝中,复发率高达40%。最近,已研发出生物合成的Phasix补片,其在12 - 18个月内可吸收。可吸收补片可能是减少切口疝修复短期和长期(补片相关)并发症的一种解决方案。然而,补片吸收后的长期结果尚少。

方法

通过体格检查和计算机断层扫描(CT)纳入参与Phasix试验(Clinicaltrials.gov:NCT02720042)的VHWG 3级切口中线疝患者。主要结局是疝复发;次要结局包括长期补片并发症、再次手术和腹壁疼痛[视觉模拟评分(VAS):0 - 10]。

结果

总共见到61/84(72.6%)例患者。中位随访时间为60.0[四分位间距(IQR):55 - 64]个月。39例患者(68.4%)进行了CT扫描。5年后计算得出复发率为15.9%(95%置信区间:6.9 - 24.8)。在2至5年期间发现4例新的复发(6.6%)。2例无症状。总共发现13/84例复发。未发生长期补片并发症和/或干预措施。VAS评分为0(IQR:0 - 2)。

结论

在高危患者(VHWG 3级,体重指数>28)中使用Phasix补片进行疝修补,在2至5年随访期间复发率为15.9%;疼痛评分低;未出现与补片相关的并发症或因慢性疼痛再次手术。出现4例新的复发,2例无症状。聚-4-羟基丁酸补片对VHWG 3级患者进行疝修补是一种安全的补片,可避免疼痛和补片感染等长期补片并发症。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d342/10735126/ac017b5a100a/as9-4-e366-g001.jpg

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