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Background: The success of newly introduced surgical techniques is generally primarily assessed by surgical outcome measures. However, data on medical liability should concomitantly be used to evaluate provided care as they give a unique insight into substandard care from patient's point of view. The aim of this study was to analyze the number and type of medical claims after laparoscopic gynecologic procedures since the introduction of advanced laparoscopy two decades ago. Secondly, our objective was to identify trends and/or risk factors associated with these claims.Methods: To identify the claims, we searched the databases of the two largest medical liability mutual insurance companies in The Netherlands (MediRisk and Centramed), covering together 96% of the Dutch hospitals. All claims related to laparoscopic gynecologic surgery and filed between 1993 and 2015 were included.Results: A total of 133 claims met our inclusion criteria, of which 54 were accepted claims (41%) and 79 rejected (59%). The number of claims remained relatively constant over time. The majority of claims were filed for visceral and/or vascular injuries (82%), specifically to the bowel (40%) and ureters (20%). More than one-third of the injuries were entry related (38%) and 77% of the claims were filed after non-advanced procedures. A delay in diagnosing injuries was the primary reason for financial compensation (33%). The median sum paid to patients was €12,000 (500-848,689). In 90 claims, an attorney was defending the patient (83% for the accepted claims; 57% for the rejected claims).Conclusion: The number of claims remained relatively constant during the study period. Most claims were provoked by bowel and ureter injuries. Delay in recognizing injuries was the most encountered reason for granting financial compensation. Entering the abdominal cavity during laparoscopy continues to be a potential dangerous step. As a result, gynecologists are recommended to thoroughly counsel patients undergoing any laparoscopic procedure, even regarding the risk of entry-related injuries. [ABSTRACT FROM AUTHOR]

Background: Since the introduction of minimally invasive surgery (MIS), concerns for patient safety are more often brought to the attention. Knowledge about and awareness of patient safety risk factors are crucial in order to improve and enhance the surgical team, the environment, and finally surgical performance. The aim of this study was to identify and quantify patient safety risk factors in laparoscopic hysterectomy and to determine their influence on surgical outcomes.Methods: A prospective multicenter study was conducted from April 2014 to January 2016, participating gynecologists registered their performed laparoscopic hysterectomies (LHs). If deemed necessary, gynecologists could fill out a checklist with validated patient safety risk factors. Association between procedures with and without an occurred risk factor(s) and the surgical outcomes (blood loss, operative time, and complications) were assessed, using multivariate logistic regression and generalized estimation equations.Results: Eighty-five gynecologists participated in the study, registering a total of 2237 LHs. For 627(28 %) procedures, the checklist was entered (in total 920 items). The most reported risk factors were related to the surgeon (19.6 %), the surgical team (14.4 %), technology (16.6 %), and the patient (26.8 %). The procedures where a risk factor was registered had significantly less favorable outcomes, higher complication rate (10.5 vs. 4.8 % (p = 0.002), longer operative time [114 vs. 95 min (p < 0.001)], and more blood loss [110 vs. 168 mL (p = 0.047)], which was mainly due to the technological and patient-related risk factors.Conclusion: Technological incidents are the most important and clinically relevant risk factors affecting surgical outcomes of LH. Future improvements of MIS need to focus on this. As awareness of safety risk factors in MIS is important, embedding of a safety risk factor checklist in registration systems will help surgeons to evaluate and improve their individual performance. This will inherently improve the surgical outcomes and thus patient safety. [ABSTRACT FROM AUTHOR]

Background: The current health care system has an urgent need for tools to measure quality. A wide range of quality indicators have been developed in an attempt to differentiate between high-quality and low-quality health care processes. However, one of the main issues of currently used indicators is the lack of case-mix correction and improvement possibilities. Case-mix is defined as specific (patient) characteristics that are known to potentially affect (surgical) outcome. If these characteristics are not taken into consideration, comparisons of outcome among health care providers may not be valid.Objective: The objective of the study was to develop and test a quality assessment tool for laparoscopic hysterectomy, which can serve as a new outcome quality indicator.Study Design: This is a prospective, international, multicenter implementation study. A web-based application was developed with 3 main goals: (1) to measure the surgeon's performance using 3 primary outcomes (blood loss, operative time, and complications); (2) to provide immediate individual feedback using cumulative observed-minus-expected graphs; and (3) to detect consistently suboptimal performance after correcting for case-mix characteristics. All gynecologists who perform laparoscopic hysterectomies were requested to register their procedures in the application. A patient safety risk factor checklist was used by the surgeon for reflection. Thereafter a prospective implementation study was performed, and the application was tested using a survey that included the System Usability Scale.Results: A total of 2066 laparoscopic hysterectomies were registered by 81 gynecologists. Mean operative time was 100 ± 39 minutes, blood loss 127 ± 163 mL, and the complication rate 6.1%. The overall survey response rate was 75%, and the mean System Usability Scale was 76.5 ± 13.6, which indicates that the application was good to excellent. The majority of surgeons reported that the application made them more aware of their performance, the outcomes, and patient safety, and they noted that the application provided motivation for improving future performance.Conclusion: We report the development and test of a real-time, dynamic, quality assessment tool for measuring individual surgical outcome for laparoscopic hysterectomy. Importantly, this tool provides opportunities for improving surgical performance. Our study provides a foundation for helping clinicians develop evidence-based quality indicators for other surgical procedures. [ABSTRACT FROM AUTHOR]

Objective: To identify predictors of postsurgical adhesion formation in peritoneal fluid and plasma, and assess efficacy and safety of reteplase (recombinant plasminogen activator [r-PA]). Design: Prospective randomized study. Setting: University Medical Center. Patient(s): Twenty-six abdominal myomectomy patients with early second-look laparoscopy (ESL). Intervention(s): Randomization to IP treatment with 1 mg reteplase in 300 mL Ringer''s lactate or 300 mL Ringer''s lactate only. Scoring of adhesions and collecting peritoneal fluid during both surgical procedures and collecting plasma samples at ten time points. Main Outcome Measure(s): Incidence, severity, and extent of adhesions at ESL. Concentrations of C-reactive protein (CRP), tissue-type plasminogen activator (tPA), plasminogen activator inhibitor 1 (PAI-1), and fibrin degradation products (FbDPs). Result(s): Significant correlation between the extent of uterine adhesion formation and preoperative plasma levels of CRP (rs = 0.558), PAI-1 (rs = 0.413), and the change in tPA concentration in peritoneal fluid from initial surgery to ESL (Δ+PA: rs = −0.636). No significant differences in adhesion scores between treatment and control groups. Conclusion(s): Our finding that preoperative plasma CRP and PAI-1-levels are significantly correlated with extent of adhesion formation points to a role of chronic inflammation in the disease process. Results are highly indicative for the paradigm that adhesions are caused by an insufficiency in peritoneal fibrinolytic capacity. For successful adhesion prevention therapy relatively high amounts of r-PA are required. [Copyright &y& Elsevier]