Windfuhr Jochen P
Department of Otorhinolaryngology, Plastic Head and Neck Surgery, Kliniken Maria Hilf, Mönchengladbach, Germany.
GMS Curr Top Otorhinolaryngol Head Neck Surg. 2013 Dec 13;12:Doc08. doi: 10.3205/cto000100.
Septoplasty, tonsillectomy (with and without adenoidectomy) and cervical lymph node excision are amongst the most common 50 inpatient operations in Germany. Intracapsular tonsillectomies (i.e. tonsillotomies) are increasingly performed. The aim of this study was to evaluate technical traps and pitfalls as well as alleged medical malpractice associated with tonsillectomy (TE), adenoidectomy (AE), tonsillotomy (TT), septoplasty (SP) and cervical lymph node excision (LN).
A questionnaire was sent to the Regional Medical Conciliation Boards, Medical Services of the Health Insurance Companies (MDK) and Regional Institutes of Forensic Medicine in Germany to collect anonymized cases of complications following TE, TT, AE, LN and SP. The results were discussed in the light of the contemporary medical literature and published trials and verdicts in Germany.
The response rate of our survey was 55.9%. The Institutes of Forensic Medicine contributed nine cases, 49 cases were submitted by the Regional Conciliation Boards and none by MDK. All forensic cases were associated with exsanguinations following tonsillectomy including two children (5 and 8 years of age) and seven adults (aged 20 to 69 years). The fatal post-tonsillectomy hemorrhage (PTH) had occurred 8.7 days on average; four patients experienced the bleeding episode at home (day 5, 8, 9 and 17, respectively). Repeated episodes of bleeding requiring surgical intervention had occurred in 6 patients. Three Conciliation Boards submitted decicions associated with TT (1), AE (4), LN (3), SP (16) and TE (25). Cases with lethal outcome were not registered. Only three of the 49 cases were assessed as surgical malpractice (6.1%) including lesion of the spinal accessory nerve, wrong indication for TE and dental lesion after insertion of the mouth gag. The review of the medico legal literature yielded 71 published verdicts after AE and TE (29), LN (28) and SP (14) of which 37 resulted in compensation of malpractice after LN (16; 57%), TE (10; 37%), SP (8; 57%) and AE (2; 100%). There were 16 cases of PTH amongst 27 trials after TE resulting either in death (5) or apallic syndrome (5). Bleeding complications had occurred on the day of surgery in only 2 patients. 16 trials were based on malpractice claims following SP encompassing lack of informed consent (6), anosmia (4), septal perforation (2), frontobasal injury (2) and dry nose (2). Trials after LN procedures were associated exclusively with a lesion of the spinal accessory nerve (28), including lack of informed consent in 19 cases. 49 cases (69%) were decided for the defendant, 22 (31%) were decided for the plaintiff with monetary compensation in 7 of 29 AE/TE-trials, 9 of 28 LN-trials and 6 of 14 SP-trials. Lack of informed consent was not registered for AE/TE but LN (11) and SP (2).
Complicated cases following TE, TT, ATE, SP and LN are not systematically collected in Germany. It can be assumed, that not every complicated case is published in the medical literature or law journals and therefore not obtainable for scientific research. Alleged medical malpracice is proven for less than 6% before trial stage. Approximately half of all cases result in a plaintiff verdict or settlement at court. Proper documentation of a thourough counselling, examination, indication, informed consent and follow-up assists the surgeon in litigation. An adequate complication management of PTH is essential, including instructions for the patients/parents, instructions for the medical staff and readily available surgical instruments. Successful outcome of life-threatening PTH is widely based on a proper airway management in an interdisciplinary approach. Electrosurgical tonsillectomy techniques were repeatedly labeled as a risk factor for bleeding complications following TE. Institutions should analyse the individual PTH rate on a yearly basis. Contradictory expert opinions and verdicts of the courts concerning spinal accesory nerve lesions following LN are due to a lack of a surgical standard.
鼻中隔成形术、扁桃体切除术(伴或不伴腺样体切除术)及颈部淋巴结切除术是德国最常见的50种住院手术。囊内扁桃体切除术(即扁桃体切开术)的实施越来越多。本研究的目的是评估与扁桃体切除术(TE)、腺样体切除术(AE)、扁桃体切开术(TT)、鼻中隔成形术(SP)及颈部淋巴结切除术(LN)相关的技术难点与陷阱以及所谓的医疗过失。
向德国地区医疗调解委员会、健康保险公司医疗服务机构(MDK)及地区法医学研究所发送调查问卷,以收集TE、TT、AE、LN及SP术后并发症的匿名病例。根据当代医学文献以及德国已发表的试验和裁决对结果进行讨论。
我们调查的回复率为55.9%。法医学研究所提供了9例病例,地区调解委员会提交了49例病例,MDK未提交病例。所有法医病例均与扁桃体切除术后出血有关,其中包括两名儿童(5岁和8岁)和7名成年人(20至69岁)。扁桃体切除术后致命性出血(PTH)平均发生在8.7天;4例患者在家中发生出血事件(分别为第5、8、9和17天)。6例患者发生了需要手术干预的反复出血事件。三个调解委员会提交了与TT(1例)、AE(4例)、LN(3例)、SP(16例)和TE(25例)相关的决定。未记录有致命结局的病例。49例病例中只有3例被判定为医疗过失(6.1%),包括副神经损伤、TE的错误指征以及插入开口器后牙齿损伤。对法医学文献的回顾得出了71例AE和TE(29例)、LN(28例)和SP(14例)后的已发表裁决,其中37例在LN(16例;57%)、TE(10例;37%)、SP(8例;57%)和AE(2例;100%)后导致医疗过失赔偿。TE后的27项试验中有16例PTH病例,导致死亡(5例)或无动性缄默综合征(5例)。仅2例患者在手术当天发生出血并发症。16项试验基于SP后的医疗过失索赔,包括缺乏知情同意(6例)、嗅觉丧失(4例)、鼻中隔穿孔(2例)、额底损伤(2例)和鼻干燥(2例)。LN手术后的试验仅与副神经损伤(28例)相关,其中19例包括缺乏知情同意。49例病例(69%)判定被告胜诉,22例(31%)判定原告胜诉,29例AE/TE试验中的7例、28例LN试验中的9例和14例SP试验中的6例给予金钱赔偿。AE/TE未记录缺乏知情同意的情况,但LN(11例)和SP(2例)有记录。
德国未系统收集TE、TT、ATE、SP和LN后的复杂病例。可以推测,并非每个复杂病例都发表在医学文献或法律期刊上,因此无法用于科学研究。在审判阶段之前,被指控的医疗过失被证实的不到6%。所有病例中约有一半在法庭上判定原告胜诉或达成和解。对全面咨询、检查、指征、知情同意和随访进行妥善记录有助于外科医生应对诉讼。对PTH进行充分的并发症管理至关重要,包括对患者/家长的指导、对医务人员的指导以及随时可用的手术器械。危及生命的PTH的成功结局广泛基于跨学科方法中的适当气道管理。电刀扁桃体切除技术多次被标记为TE后出血并发症的危险因素。各机构应每年分析个体PTH发生率。关于LN后副神经损伤的矛盾专家意见和法庭裁决是由于缺乏手术标准。