Measuring surgical safety during minimally invasive surgical procedures: a validation study.

BACKGROUND: During the implementation of new interventions (i.e., surgical devices and technologies) in the operating room, surgical safety might be compromised. Current safety measures are insufficient in detecting safety hazards during this process. The aim of the study was to observe whether surgical teams are capable of measuring surgical safety, especially with regard to the introduction of new interventions. METHODS: A Surgical Safety Questionnaire was developed that had to be filled out directly postoperative by three surgical team members. A potential safety concern was defined as at least one answer between (strongly) disagree and indifferent. The validity of the questionnaire was assessed by comparison with the results from video analysis. Two different observers annotated the presence and effect of surgical flow disturbances during 40 laparoscopic hysterectomies performed between November 2010 and April 2012. RESULTS: The surgeon reported a potential safety concern in 16% (85/520 questions). With respect to the scrub nurse and anesthesiologist, this was both 9% (46/520). With respect to the preparation, functioning, and ease of use of the devices in 37.5-47.5% (15-19/40 procedures) a potential safety concern was reported by one or more team members. During procedures after which a potential safety concern was reported, surgical flow disturbances lasted a higher percentage of the procedure duration [9.3 ± 6.2 vs. 2.9 ± 3.7% (mean ± SD), p < .001]. After procedures during which a new instrument or device was used, more potential safety concerns were reported (51.2 vs. 23.1%, p < .001). CONCLUSIONS: Potential safety concerns were especially reported during procedures in which a relatively high percentage of the duration consisted of surgical flow disturbances and during procedures in which a new instrument or device was used. The Surgical Safety Questionnaire can act as a validated tool to evaluate and maintain surgical safety during minimally invasive procedures, especially during the introduction of a new intervention.

Surgical flow disturbances in dedicated minimally invasive surgery suites: an observational study to assess its supposed superiority over conventional suites.

BACKGROUND: Minimally invasive surgery (MIS) is frequently compromised by surgical flow disturbances due to technology- and equipment-related failures. Compared with MIS in a conventional cart-based OR, performing MIS in a dedicated integrated operating room (OR) is supposed to be beneficial to patient safety. The aim of this study was to compare a conventional OR with an integrated OR with regard to the incidence and effect of equipment-related surgical flow disturbances during an advanced laparoscopic gynecological procedure [laparoscopic hysterectomy (LH)]. METHODS: Using video recording, 40 LHs performed between November 2010 and April 2012 (20 in a conventional cart-based OR and 20 in an integrated OR) were analyzed by two different observers. Outcome measures were the number, duration and effect (on a seven-point ordinal scale) of the surgical flow disturbances (e.g., malfunctioning, intraoperative repositioning, setup device). RESULTS: A total of 103 h and 45 min was observed. The interobserver agreement was high (kappa .85, p < .001). Procedure time was not significantly different (NS) [conventional OR vs. integrated OR, minutes ± standard deviation (SD), mean 161 ± 27 vs. 150 ± 34]. A total of 1651 surgical flow disturbances were observed (mean ± SD per procedure 40.8 ± 19.4 vs. 41.8 ± 15.9, NS). The mean number of surgical flow disturbances per procedure with regard to equipment was 6.3 ± 3.7 versus 8.5 ± 4.0, NS. No clinically relevant differences in the mean effect of these disturbances on the surgical flow between the two OR setups were observed. CONCLUSIONS: Performing LH in an integrated OR did not reduce the number of surgical flow disturbances nor the effect of these disturbances. Furthermore, in the integrated OR, repositioning of the monitors was a frequent and time-consuming source of disturbance. In order to maintain the high standard of surgical safety, the entire surgical team has to be aware that by performing surgery in an integrated OR different potential source for disruption arise.

Treatment with methotrexate of a cornual pregnancy following endometrial resection.

OBJECTIVES: Endometrial resection is a procedure often performed for treatment of menorrhagia. Despite the fact that amenorrhoea frequently ensues, some normal endometrium can remain present and become the implantation site of a pregnancy. Such an event is uncommon (0.7%); however, the likelihood of an ectopic pregnancy is increased. This case report calls the reader's attention to the risk of intra- and extrauterine pregnancies and the necessity for contraception after endometrial resection, even in cases where amenorrhoea supervenes. CASE: A 46-year-old woman with prior endometrial resection and subsequent amenorrhoea, was diagnosed with a cornual pregnancy. She was successfully treated with systemic methotrexate, which was given in an outpatient clinic. CONCLUSION: Clinicians should be aware of the increased likelihood of an ectopic pregnancy after endometrial resection. All women submitting to this procedure should be counselled about the need for contraception, even in cases where amenorrhoea develops.

[Safe introduction of laparoscopic hysterectomy using a mentor]. / Veilige introductie van laparoscopische hysterectomie met een mentor.

OBJECTIVE: Evaluation of the introduction of laparoscopic hysterectomy in a teaching hospital by means of a structured mentor-traineeship. DESIGN: Retrospective, with prospectively designed database. METHODS: By means of a mentor-traineeship the technique of laparoscopic hysterectomy was introduced to two gynaecologists in a teaching hospital. The primary outcome measures of the laparoscopic hysterectomies were duration of the operation, blood loss and complications. In addition, patient characteristics as well as main indication for surgery were analysed. The training period was defined per trainee as the relationship between operation duration and consecutive operations. Similar outcome measures of all laparoscopic hysterectomies performed during the same period by the mentor in his own hospital were used as a reference. RESULTS: During both mentor-traineeships, the main indication for surgery, the operation characteristics and the percentage of complications were comparable between trainee and mentor (p = 0.633). The operating time did not differ clinically significantly between trainee and mentor. Both trainees realised a learning curve, while the operating time remained statistically constant and comparable to that of the mentor. During the mentor-traineeships and the two following years the number of laparoscopic hysterectomies increased (p = 0.001), while the number of abdominal hysterectomies diminished (p = 0.002). CONCLUSION: A mentor was able to effectively introduce laparoscopic hysterectomy in a clinic without jeopardizing patient safety, as main indication, operating time and percentage of complications were comparable to those of the mentor in his/her own hospital. Due to this safe method of introduction of the new procedure more patients are able to benefit from the advantages of this surgical technique.

Teach the teachers: an observational study on mentor traineeship in gynecological laparoscopic surgery.

BACKGROUND: To evaluate the effect of a mentor traineeship in laparoscopic surgery in a teaching hospital. METHOD: This observational study was performed between January 1997 and December 2004 at Bronovo Hospital, The Hague, The Netherlands. Since January 2001, an advanced endoscopic gynecologist has mentored a trainee in laparoscopic surgery. Data on the trainee's procedures preceding (1997-2000) and during the mentor traineeship (2001-2004) were compared. The number and type of procedures performed, complications and conversions were derived from a prospectively kept database supplemented by a retrospective chart review. Operating times for total laparoscopic hysterectomy (TLH) were registered to establish the trainee's learning curve. RESULTS: Since the presence of a mentor, the trainee has performed significantly more advanced laparoscopic procedures. Despite the significant increase in advanced cases, the trainee's laparoscopic conversion rate to laparotomy remained stable between period 1 and period 2 (7.5 and 4.5%, respectively, p = 0.35, 95% CI -0.033 to 0.092); moreover, for level-3 procedures the conversion rate decreased (p < 0.001, 95% CI 0.30-0.71). Despite the increase in advanced cases, the total complication rate remained stable (3.2-4.5%, p = 0.62, 95% CI -0.07 to 0.04) including the number of level-3 complications (p = 0.63, 95% CI -0.4 to 0.3). A decreasing trend in operating time for TLH was found; however, this was not significant (Spearman correlation coefficient -0.421, p = 0.81). CONCLUSIONS: Mentor traineeship in gynecology enhanced the advanced laparoscopic caseload. With the increase in advanced procedures, no increase in conversion rate, complication rate or operating times for TLH was found. Due to the mentorship, patients were not exposed to increased complications and conversions, or to the disadvantages of a prolonged operating time. Predominantly, mentor traineeship facilitated the implementation of laparoscopic surgery into an established gynecological practice in a teaching hospital.

Follow-up after incomplete hysteroscopic removal of uterine fibroids.

BACKGROUND: In this observational study, we analysed whether a period of wait and see was reasonable following incomplete removal of submucous fibroids, with regard to symptoms of abnormal uterine bleeding, and whether factors predicting subsequent surgery could be identified. METHODS: In 3 affiliated hospitals, patients with incomplete removal of submucous fibroids, treated with hysteroscopic myomectomy for abnormal uterine bleeding, between January 1997 and January 2005, were followed over time. Using life-table analysis (Kaplan-Meier method), the cumulative proportion of women having surgery-free survival following incomplete removal of submucous fibroids was calculated. Cox-proportional hazard analyses were used to analyse relationships of variables with recurrence of symptoms. RESULTS: Forty-one consecutive patients met the inclusion criteria, and were followed over time. The mean age was 42.5 years (range 27-55). The majority of patients with incomplete removal of submucous fibroids were diagnosed with type 2 fibroids. Termination of the procedure before complete removal was achieved, was principally caused by reaching the maximum fluid deficit (90.2%). The surgery-free percentages were 70.2% (95%-CI: 55.3-85.1) at 1 year, 54.8% (95%-CI: 38.1-70.7) at 2 years, and 44.2% (95%-CI: 26.9-61.5) at 3 years. Size of fibroid (diameter) pre-operatively turned out to be of statistically significant influence, with a hazard ratio of 1.762 (95%-CI: 1.114-2.787) per cm increase in diameter (p=0.016). CONCLUSIONS: The results indicate that incomplete removal does not always seem to necessitate subsequent surgery. Instead of subsequent surgery immediately post-operatively, a wait and see policy is worth considering after incomplete removal.

Home monitors of blood glucose: comparison of precision and accuracy.

Home monitors of blood glucose (HMBGs) are gaining acceptance as part of the standard of care for ambulatory self-monitoring and treatment of diabetic patients. Currently there are several HMBGs marketed in the United States, each claiming reliability, accuracy, and "user friendliness," with most of these claims largely unsubstantiated. The objective of our study was to analyze and statistically compare the accuracy and precision of the HMBGs produced by the major competitors in this ever-expanding medical field. Accuracy of each monitor was studied by comparing the glucose value reported by each HMBG with that determined by a reference method (YSI 23A). Precision or reproducibility of results was performed by testing a single, known whole-blood glucose sample 20 times on each monitor. The precision of each device was tested on known low, normal, and elevated samples. Actual and absolute deviations from the reference standard demonstrate that the Accuchek bG and Glucoscan 2000 monitors provide relatively unbiased estimates of blood glucose, whereas the Glucokey, Glucochek II, Glucometer II, and Trendsmeter generally underestimate the true values. The Diascan and Accuchek II monitors, in a separate evaluation, demonstrated acceptable accuracy and precision. We conclude that the Accuchek bG and Glucoscan 2000 statistically are the most accurate and precise HMBGs.