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腹腔镜胆总管切开术后应用纤维蛋白胶预防胆漏:一项随机对照试验的结果。

Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial.

机构信息

Department of Surgery, Enköping Hospital, Enköping, Sweden.

Department of Clinical Science and Education, Karolinska Institute, Södersjukhuset, Stockholm, Sweden.

出版信息

J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):171-175. doi: 10.1089/lap.2020.0404. Epub 2021 Jun 14.

DOI:10.1089/lap.2020.0404
PMID:34129409
Abstract

There are several methods used to extract common bile duct (CBD) stones encountered during cholecystectomy. Intraoperative cholangiotomy, cholangioscopy, and laparoscopic CBD exploration (LCBDE) are techniques that allow removal of stones from the CBD during the index procedure. However, bile leakage following CBD exploration is a common problem. The aim of this study was to assess whether fibrin sealant applied to the duct incision is safe. Patients planned for laparoscopic gallstone surgery at the Department of Surgery, Enköping Hospital, were included in the study. In cases where perioperative cholangiography showed CBD stones, LCBDE was performed through a longitudinal incision in the CBD. Randomization between closure of the incision with polyglactin sutures or with fibrin sealant was performed. After all the stones had been removed and the incision closed according to the allocation, an abdominal drain was placed close to the incision. A T tube was placed in the CBD or a straight tube into cystic duct for eventual postoperative cholangiogram. The patient and the surgeon assessing the postoperative course were blinded to the randomized allocation. Altogether 51 patients were included from December 2012 to July 2016. Mean operative time was 188 minutes in the fibrin sealant group and 214 minutes in the suture group ( = .159). There was no significant difference between groups in bile flow in the abdominal drainage tube or in the CBD drain during the three first postoperative days. The time to removal of the abdominal drain did not differ significantly between groups. Although the present study lacks the statistical power to prove a benefit from fibrin sealant, it indicates that closure of the incision may be an option to reduce the risk for leakage. Further studies are required to confirm this. The study was retrospectively registered on clinicaltrials.gov September 5, 2015 (NCT02545153).

摘要

有几种方法可用于提取胆囊切除术中遇到的胆总管(CBD)结石。术中胆管切开术、胆管镜检查和腹腔镜胆总管探查术(LCBDE)是在指数手术期间从 CBD 中取出结石的技术。然而,CBD 探查后胆漏是一个常见问题。本研究旨在评估纤维蛋白胶施用于胆管切口是否安全。 在外科 Enköping 医院计划进行腹腔镜胆囊结石手术的患者被纳入研究。在围手术期胆管造影显示 CBD 结石的情况下,通过 CBD 的纵向切口进行 LCBDE。通过多聚丙交酯缝线或纤维蛋白胶关闭切口进行随机分组。所有结石取出并根据分配关闭切口后,在切口附近放置腹部引流管。在 CBD 中放置 T 管或直管进行术后胆管造影。患者和评估术后过程的外科医生对随机分组均不知情。 共有 51 例患者于 2012 年 12 月至 2016 年 7 月纳入研究。纤维蛋白胶组的平均手术时间为 188 分钟,缝线组为 214 分钟(=.159)。两组患者在术后 3 天内的腹部引流管胆汁流量或 CBD 引流管胆汁流量均无显著差异。两组患者腹部引流管拔除时间无显著差异。 虽然本研究缺乏证明纤维蛋白胶有益的统计学效力,但它表明缝合切口可能是降低泄漏风险的一种选择。需要进一步的研究来证实这一点。该研究于 2015 年 9 月 5 日在 clinicaltrials.gov 上进行了回顾性注册(NCT02545153)。

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