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中华疝和腹壁外科杂志(电子版)

中华疝和腹壁外科杂志(电子版) ›› 2022, Vol. 16 ›› Issue (01) : 1 -7. doi: 10.3877/cma.j.issn.1674-392X.2022.01.001

所属专题： 指南共识；

专家共识

食管裂孔疝修补材料的选择及固定的专家微共识
尹杰1, 杨慧琪2, 逯景辉3   
  1. 1. 首都医科大学附属北京友谊医院普通外科
    2. 首都医科大学附属北京朝阳医院疝和腹壁外科
    3. 山东大学齐鲁医院普通外科
  • 收稿日期:2021-12-28 出版日期:2022-02-18

Micro consensus among experts on the selection and fixation of hiatal hernia repair materials

Jie Yin1, Huiqi Yang2, Jinghui Lu3   

  • Received:2021-12-28 Published:2022-02-18
全文 ( ) 下载PDF ( ) 导出引用
引用本文：

尹杰, 杨慧琪, 逯景辉. 食管裂孔疝修补材料的选择及固定的专家微共识[J]. 中华疝和腹壁外科杂志(电子版), 2022, 16(01): 1-7.

Jie Yin, Huiqi Yang, Jinghui Lu. Micro consensus among experts on the selection and fixation of hiatal hernia repair materials[J]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2022, 16(01): 1-7.

食管裂孔疝修补材料的选择及固定的专家微共识在充分论证及讨论的基础上，吸纳了最新高级别循证医学证据，从食管裂孔疝补片修补的指征、补片材料的选择、补片形状及大小及补片固定方法等方面达成共识。本共识更具时代特色、更符合中国国情和先进性，为今后临床医疗提供更为精确和科学的指导性意见和策略。

关键词: 疝，食管裂孔, 修补材料, 固定
表1 文献的证据级别及内容
Ⅰ 系统回顾或者随机比较实验的Meta分析
Ⅱ 1个以上的随机比较试验
Ⅲ 非随机比较试验
Ⅳ 分析流行病学研究
Ⅴ 记述研究
Ⅵ 非基于患者资料的专业委员会和专家的个人意见
表2 推荐结果整体证据等级（确实性）
强(A) 对效果的推定值有很强的确信(基于很强的根据)
中(B) 对效果的推定值有中等强度的确信(基于中等程度的根据)
弱(C) 对效果的推定值的确信有限(基于弱的根据)
非常弱(D) 几乎不能确信效果的推定值(基于非常弱的根据)
表3 近5年来发表的合成补片的相关文献
补片类型 研究类型 第一作者/发表年 研究对象 样本量 随访时间(个月) 复发率 补片相关并发症发生率
总复发率 症状复发率 解剖学复发率
TiMESH[16] RCT Watson/2015 巨大裂孔疝 42 6 NA NA 0 NA
TiMESH[6] RCT Oor/2018 巨大裂孔疝 36 6 NA 25% NA 0
TiMESH[17] RCT Watson/2020 巨大裂孔疝 42 36~48 NA NA 14.30% NA
TiMESH[18] 回顾性 Koetje/2017 食管裂孔疝 62 33.3±13.6 NA 16.10% 25.80% 0
TiMESH[19] 回顾性 Gordon/2018 巨大裂孔疝 50 中位108 NA 33% 38% 5.6%(吞咽困难)
PCO[20] 回顾性 田书瑞/2016 巨大裂孔疝 120 6~48 5% 1.70% 3.30% NA
PCO[21] 回顾性 郑伟/2019 年龄>60岁的食管裂孔疝 33 6~42 0 0 0 0
表4 近5年来发表的可吸收补片的相关文献
补片类型 第一作者/发表年 研究类型 研究对象 样本量 随访时间(个月) 复发率 补片相关并发症发生率
总复发率 症状复发率 解剖学复发率
Surgisis(Cook)[22] Korwar/2019 回顾性 食管裂孔疝 154 12 32.50% 28.73% 20.40% 2.59%(吞咽困难)
Surgisis(Cook)[23] 吕杰敏/2015 回顾性 食管裂孔疝 20 3~18 0% 0% 0% NA
Surgisis(Cook)[17] Watson/2020 RCT 巨大裂孔疝 41 36~48 NA NA 13.30% NA
Surgisis(Cook)[16] Watson/2015 RCT 巨大裂孔疝 41 6 NA NA 5.90% NA
Gore Bio A[24] Asti/2017 回顾性 食管裂孔疝 100 30 NA 2% 7% 0
Gore Bio A[25] Alicuben/2017 回顾性 食管裂孔疝 64 15 6% 3% 3% 0
Gore Bio A[26] Armijo/2020 回顾性 食管裂孔疝 83 27(1~166) 38% NA NA 0
Gore Bio A[8] Tartaglia/2020 回顾性 食管裂孔疝 44 36 4.50% 0 4.50% 0
Gore Bio A[27] Bersellia/2015 回顾性 巨大裂孔疝 8 23.5(14~44) 25% 0 25% 0
Gore Bio A[28] Olson/2018 回顾性 食管旁疝 399 44.7±22.8 NA 16.1% NA 0.33%(食管狭窄)
Gore Bio A[29] Iossa/2019 回顾性 肥胖的食管裂孔疝 92 41(17~51) NA NA 5.40% 8.7%(吞咽困难)；16.3%(侵蚀)
Gentrix®[30] Sasse/2019 病例系列 巨大裂孔疝 32 12 (4~27) 0 0 0 3.1%(吞咽困难)
Gentrix®[31] Howell/2018 回顾性 食管裂孔疝 56 NA NA 1.80% NA 3.6%(吞咽困难)
Gentrix®[32] Zografakis/2018 回顾性 食管裂孔疝 62 3 NA 2.4% 22% NA
Gentrix®[33] Sasse/2016 回顾性 食管裂孔疝 15 37(24~56) 0 0 0 NA
Phasix-ST[34] Tonucci/2019 队列 巨大裂孔疝 73 中位17 8% NA NA 10.0%(吞咽困难)
Phasix-ST[35] Abdelmoaty/2019 回顾性 食管旁疝 50 12 NA NA 3.2% 0
Permacol®[36] Antonakis/2016 观察性 巨大裂孔疝 10 27±18 10% 10% NA NA
Permacol®[37] Travers/2016 回顾性 巨大裂孔疝 50 36 4% 4% 0 8%(吞咽困难)
MIROMESH[38] Rosen/2019 RCT 食管旁疝 27 24 0 0 10% 3.7%(吞咽困难)
TiO2Mesh™[39] Khaled/2019 回顾性 巨大裂孔疝 27 平均18 NA 11% 7% 0
Alloderm®[26] Armijo/2020 回顾性 食管裂孔疝 162 中位27 44% NA NA 0
Veritas®[40] Lidor/2015 队列 食管旁疝 70 12 27% 1.40% 27% NA
表5 合成与生物补片之间的随机对照研究
第一作者/发表年 研究类型 研究对象 随访时间(个月) 样本量 补片商品名 症状复发率 解剖学复发率 补片相关的并发症发生率
对照组 试验组 对照组 试验组 对照组 试验组 对照组 试验组 对照组 试验组
Watson/2015[16] RCT 巨大裂孔疝 6 41 42 Surgisis TiMesh NA NA 5.90% 0 NA NA
Watson/2020[17] RCT 巨大裂孔疝 60 41 42 Surgisis TiMesh NA NA 13.30% 14.30% NA NA
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