Crozier Jack, Williams Ann, Chan Steven T F, Thompson Graeme
Department of Surgery, Western Health, Footscray, Victoria, Australia.
Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.
ANZ J Surg. 2018 Jan;88(1-2):E55-E59. doi: 10.1111/ans.13888. Epub 2017 Mar 14.
Prior to all surgical procedures, possible risks are outlined to patients during an informed consent discussion, and they are invited to ask questions. Written consent records this discussion and signals a patient's willingness to proceed with surgery. This study aims to improve the documentation of complications discussed during laparoscopic cholecystectomy consent through the introduction of a procedure-specific consent form.
Phase 1 included a retrospective analysis of possible complications documented on standard consent forms for laparoscopic cholecystectomy. Phase 2 was a prospective randomized comparison of existing standard consent forms versus procedure-specific consent forms measuring the documentation of significant complications as identified from the Royal Australasian College of Surgeons brochure for laparoscopic cholecystectomy. These include bile duct injury, bile leak, bleeding, infection, conversion and damage to other organs. The proportion of participants in each cohort with the documentation of specific complications was assessed using the two-sample test of differences in proportions.
Phase 1 of the study found that the possible risk of bleeding was documented in 82.1% of cases, while damage to other organs was only documented in 7.7%. Phase 2 of the study showed significant improvements in the documentation of specific complications for both standard and procedure-specific consent cohorts; 76.5% of participants in the procedure-specific consent cohort had all complications documented, while no participants in the phase 1 cohort had all complications documented.
Introduction of a procedure-specific consent form for laparoscopic cholecystectomy has improved the documentation of a standard set of complications.
在所有外科手术前，会在知情同意讨论期间向患者概述可能的风险，并邀请他们提问。书面同意书记录了此讨论，并表明患者愿意进行手术。本研究旨在通过引入特定手术同意书来改善腹腔镜胆囊切除术同意过程中讨论的并发症的记录。
第一阶段包括对腹腔镜胆囊切除术标准同意书上记录的可能并发症进行回顾性分析。第二阶段是对现有标准同意书与特定手术同意书进行前瞻性随机比较，根据澳大利亚皇家外科学院腹腔镜胆囊切除术手册确定的重大并发症记录情况进行测量。这些并发症包括胆管损伤、胆漏、出血、感染、中转开腹和其他器官损伤。使用比例差异的双样本检验评估每个队列中记录特定并发症的参与者比例。
研究的第一阶段发现，82.1%的病例记录了出血的可能风险，而其他器官损伤仅在7.7%的病例中被记录。研究的第二阶段表明，标准同意书队列和特定手术同意书队列在特定并发症记录方面均有显著改善；特定手术同意书队列中76.5%的参与者记录了所有并发症，而第一阶段队列中没有参与者记录所有并发症。
引入腹腔镜胆囊切除术特定手术同意书改善了一组标准并发症的记录。
