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LapEmerge 试验:腹腔镜紧急结肠切除术的研究方案——一项多中心、开放标签、随机对照试验。

LapEmerge trial: study protocol for a laparoscopic approach for emergency colon resection-a multicenter, open label, randomized controlled trial.

机构信息

Gastroenterological Surgery, Päijät-Häme Central Hospital, Keskussairaalankatu 7, 15850, Lahti, Finland.

Helsinki University, Helsinki, Finland.

出版信息

Trials. 2024 Apr 17;25(1):268. doi: 10.1186/s13063-024-08058-0.

Abstract

BACKGROUND

Due to faster recovery and lower morbidity rates, laparoscopy has become the gold standard in elective colorectal surgery for both the benign and malignant forms of the disease. A substantial proportion of colorectal operations are, however, carried out in emergency settings, and most of the emergency resections are still performed open. The aim of this study is to compare the laparoscopic versus open approach for emergency colorectal surgery.

METHOD/DESIGN: This is a multicenter prospective randomized controlled trial including adult patients presenting with a condition requiring emergency colorectal resection.

DISCUSSION

Previous studies cautiously recommend wider use of laparoscopy in emergency colorectal resections, but all earlier reports are retrospective, are mostly single-center studies, and have limited numbers of patients. Laparoscopy may involve some unpredictable risks that have not yet been reported because of the infrequent use of the techniqueded to assess the safety of laparoscopy as well as the advantages and disadvantages of open compared with laparoscopic emergency surgery.

TRIAL REGISTRATION

Trial registration number:  ClinicalTrials.gov   NCT05005117 . Registered on August 12, 2021.

摘要

背景

由于恢复更快和发病率更低,腹腔镜已成为良性和恶性疾病的择期结直肠手术的金标准。然而,相当一部分结直肠手术是在紧急情况下进行的,而且大多数紧急切除术仍然采用开放方式进行。本研究旨在比较腹腔镜与开放方法在紧急结直肠手术中的应用。

方法/设计:这是一项多中心前瞻性随机对照试验,纳入了因需要紧急结直肠切除术而就诊的成年患者。

讨论

之前的研究谨慎地建议在紧急结直肠切除术中更广泛地使用腹腔镜,但所有早期报告都是回顾性的,大多是单中心研究,且患者数量有限。由于腹腔镜技术使用频率较低,尚未报道一些尚未报道的不可预测的风险,因此需要评估腹腔镜的安全性,以及与开放手术相比,腹腔镜紧急手术的优缺点。

试验注册

试验注册号:ClinicalTrials.gov NCT05005117。于 2021 年 8 月 12 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52bf/11022348/21ca5ba878d9/13063_2024_8058_Fig1_HTML.jpg

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