Department of Hepatobiliary and Pancreatic Surgery, Newcastle University NHS Trust Hospitals, Newcastle, UK.
Institute of Cellular Medicine, Newcastle University, Newcastle, UK.
Hernia. 2021 Feb;25(1):3-12. doi: 10.1007/s10029-020-02217-3. Epub 2020 May 24.
Achieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterise the stage of innovation for bioabsorbable mesh devices used during both midline closure prophylaxis and complex abdominal wall reconstruction and to evaluate the quality of current evidence.
A systematic review of published and ongoing studies was performed until 31st December 2019. Inclusion criteria were studies where bioabsorbable mesh was used to support fascial closure either prophylactically after midline laparotomy or for repair of incisional hernia with midline incision. Exclusion criteria were: (1) study design was a systematic review, meta-analysis, letter, review, comment, or conference abstract; (2) included less than p patients; (3) only evaluated biological, synthetic or composite meshes. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the risk of bias in non-randomised studies of interventions (ROBINS-I) criteria for study quality.
Twelve studies including 1287 patients were included. Three studies considered mesh prophylaxis and nine studies considered hernia repair. There were only two published studies of IDEAL 2B. The remainder was IDEAL 2A studies. The quality of the evidence was categorised as having a risk of bias of a moderate, serious or critical level in nine of the twelve included studies using the ROBINS-I tool.
The evidence base for bioabsorbable mesh is limited. Better reporting and quality control of surgical techniques are needed. Although new trial results over the next decade will improve the evidence base, more trials in emergency and contaminated settings are required to establish the limits of indication.
实现复杂或污染的腹壁切口的稳定闭合仍然具有挑战性。本研究旨在描述用于中线闭合预防和复杂腹壁重建的可吸收网片装置的创新阶段，并评估当前证据的质量。
对已发表和正在进行的研究进行了系统评价，直到 2019 年 12 月 31 日。纳入标准是使用可吸收网片支持中线剖腹术后筋膜闭合或中线切口修复切口疝的研究。排除标准是：（1）研究设计为系统评价、荟萃分析、信件、综述、评论或会议摘要；（2）纳入患者少于 p；（3）仅评估生物、合成或复合网片。主要结局指标是 IDEAL 框架创新阶段。次要结局指标是干预措施非随机研究的偏倚风险（ROBINS-I）标准的研究质量。
共纳入 12 项研究，包括 1287 例患者。3 项研究考虑了网片预防，9 项研究考虑了疝修补。仅有两项关于 IDEAL 2B 的已发表研究。其余的是 IDEAL 2A 研究。使用 ROBINS-I 工具，在 12 项纳入研究中有 9 项研究的证据质量被归类为存在中度、严重或关键偏倚风险。
可吸收网片的证据基础有限。需要更好地报告和控制手术技术的质量。虽然未来十年的新试验结果将改善证据基础，但仍需要更多在紧急和污染环境下的试验来确定适应证的限制。
