Ferrús-Torres Enrique, Valmaseda-Castellón Eduard, Berini-Aytés Leonardo, Gay-Escoda Cosme
Master of Oral Surgery and Implantology, School of Dentistry of the University of Barcelona, Barcelona, Spain.
J Oral Maxillofac Surg. 2011 Jan;69(1):54-8. doi: 10.1016/j.joms.2010.05.036. Epub 2010 Nov 2.
To evaluate the efficacy of the written explanation given to patients when obtaining informed consent for oral surgery, taking the surgical extraction of the impacted mandibular third molar as the clinical model for this study.
This study included 87 patients requiring surgical extraction of an impacted lower third molar. Residents of the Oral Surgery Department explained verbally and in writing 7 possible complications that could arise as a result of the operation, after which informed consent was obtained from the patient. These complications were as follows: altered sensation of the homolateral lower lip and chin; altered sensation of the tongue; swelling; trismus; pain; allergies; and infection. The patients completed a Corah anxiety test on the same day, as well as a preoperative questionnaire about their level of understanding of the informed consent. Seven days after the operation, the patients returned to have their stitches removed and for a postoperative interview.
A total of 87 patients participated in the study. Of these, 64% (n = 56) had understood the objective of the informed consent. All but 1 (1%) of the patients remembered having been informed of the possible risks before the operation. Changes in sensation of homolateral lower lip and chin (98%, n = 85) and of the tongue (86%, n = 75) were among the complications most recalled by the patients. Ninety-six percent of patients (n = 84) preferred to be informed preoperatively, and 71% (n = 61) described the signs and symptoms to be exactly as explained by the residents.
Patients do not remember the majority of the information they receive before giving informed consent. Paresthesia of the lower lip and chin on the operated side and of the tongue are among the most recalled complications. This may be due to the seriousness of this complication, to the effect it can have on the patients' daily life, and to the possibility that it may be irreversible.
以拔除下颌阻生第三磨牙作为本研究的临床模型，评估在获取口腔手术知情同意时向患者提供书面解释的效果。
本研究纳入87例需要拔除下颌阻生第三磨牙的患者。口腔外科住院医师以口头和书面形式向患者解释了手术可能出现的7种并发症，之后获得患者的知情同意。这些并发症如下：同侧下唇和下巴感觉改变；舌感觉改变；肿胀；牙关紧闭；疼痛；过敏；以及感染。患者在同一天完成了科拉焦虑测试，以及一份关于其对知情同意理解程度的术前问卷。术后7天，患者返回拆线并接受术后访谈。
共有87例患者参与本研究。其中，64%（n = 56）理解了知情同意的目的。除1例（1%）患者外，所有患者都记得在手术前被告知过可能的风险。同侧下唇和下巴感觉改变（98%，n = 85）以及舌感觉改变（86%，n = 75）是患者最常回忆起的并发症。96%的患者（n = 84）希望在术前得到告知，71%（n = 61）表示所描述的体征和症状与住院医师解释的完全一致。
患者在给予知情同意之前所接收的大部分信息都记不住。患侧下唇、下巴以及舌的感觉异常是最常被回忆起的并发症。这可能是由于该并发症的严重性、其对患者日常生活可能产生的影响以及可能不可逆转。
