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Aim of this paper is to report an unusual case of iliac artery acute thrombosis following a laparoscopic elective surgery for hiatal hernia repair and observed during a medical malpractice litigation. A 69-year-old woman submitted to laparoscopic hiatal hernia repair developed a lower limb ischemia in 5th postoperative day due to common iliac and popliteal arteries acute occlusion. Patient was urgently treated with iliac embolectomy with Fogarty's catheter, and femoral endarterectomy, followed on 1st post-operative day by external iliac artery stenting and multiple attempts of popliteal artery recanalization. After 4 years of follow-up, despite symptoms at rest were disappeared, a severe (, Highlights • Although rare, retrospective studies and surveys report an incidence ranging from 0.04% to 0.5%, direct major vascular injuries are well-known potential complications of laparoscopic surgery. • In the great majority of cases, iliac lesion become clinically evident as haemorrhagic lesions. • This is the first case of acute limb ischemia due to laparoscopic surgery related iliac lesion evaluated during a medical malpractice litigation.

Objective Sham surgery (placebo surgery) is an intervention that omits the step thought to be therapeutically necessary. In surgical clinical trials, sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect. A critical review was performed to study the statistical relevance of the clinical trials about sham surgery in the light of potential confounding factors. Materials and methods For the critical review 52 articles were included. The possible confounding factors have been studied using a structured interpretative research form designed by the authors. This form includes the following ten confounding factors: I), lack of homogeneity among inclusion/exclusion criteria. II), false double blind. III), lack of post-surgery double blind. IV), power of the study. V), sample characteristics. VI), lost patients to Follow-up. VII), gender distribution. VIII), age equilibrium. IX), lack of psychological patient evaluation. X), lack of psychiatric patient evaluation. In most of the studies, at least one confounding factor was present. Results The analysis of the confounding factors showed that they could influence the reliability of the surgical placebo effects. Conclusions The validity of sham surgery should be reconsidered., Highlights • In sham surgery literature there's no assessment on confounding factors effect. • Even if sham surgery has been used as control for over 30 years it isn't a standard. • The validity of sham surgery is not completely supported by available literature.