Complications after benign hysterectomy, according to procedure: a population-based prospective cohort study from the Danish hysterectomy database, 2004-2015.

OBJECTIVE: To compare the risk of complications associated with benign hysterectomy according to surgical procedure. DESIGN: Register-based prospective cohort study. SETTING: Danish Hysterectomy Database, 2004-2015. POPULATION: All Danish women with benign elective hysterectomy (n = 51 141). METHODS: Multivariate log-binomial regression to compute relative risks (RRs) stratified by calendar period, and adjusted for age, height, weight, smoking habits, use of alcohol, comorbidity, indications, uterine weight and adhesions. Multiple imputation and 'intention to treat' analyses were performed. MAIN OUTCOME MEASURES: Major (grades III-V) and minor (grades I-II) Clavien-Dindo modified complications within 30 days. RESULTS: Overall, major complications occurred in 3577 (7.0%) hysterectomies and minor complications occurred in 4788 (9.4%). The proportions of major and minor complications according to type of hysterectomy were: 10.3 and 9.6% for abdominal hysterectomy (AH); 4.1 and 12.1% for laparoscopic hysterectomy (LH); and 4.9 and 8.0% for vaginal hysterectomy (VH) for non-prolapse, and 2.3 and 6.4% for prolapse. In multivariate analyses, compared with VH for non-prolapse, the risk of major complications was higher for AH (RR 1.82, 95% CI 1.63-2.03) but lower for both LH (RR 0.78, 95% CI 0.68-0.90) and VH for prolapse (RR 0.55; 95% CI 0.41-0.75). For LH, the risk of major complications reduced from a RR of 0.96 (95% CI 0.75-1.22) in the time period 2004-2009 to an RR of 0.72 (95% CI 0.60-0.87) between 2010 and 2015. CONCLUSION: Laparoscopic hysterectomy and VH for uterine prolapse are associated with fewer major complications, and AH is associated with more major complications, compared with VH performed in the absence of uterine prolapse. TWEETABLE ABSTRACT: Laparoscopic hysterectomy has fewer major complications compared with vaginal hysterectomy, in the absence of uterine prolapse.

Sustained effect of simulation-based ultrasound training on clinical performance: a randomized trial.

OBJECTIVE: To study the effect of initial simulation-based transvaginal sonography (TVS) training compared with clinical training only, on the clinical performance of residents in obstetrics and gynecology (Ob-Gyn), assessed 2 months into their residency. METHODS: In a randomized study, new Ob-Gyn residents (n = 33) with no prior ultrasound experience were recruited from three teaching hospitals. Participants were allocated to either simulation-based training followed by clinical training (intervention group; n = 18) or clinical training only (control group; n = 15). The simulation-based training was performed using a virtual-reality TVS simulator until an expert performance level was attained, and was followed by training on a pelvic mannequin. After 2 months of clinical training, one TVS examination was recorded for assessment of each resident's clinical performance (n = 26). Two ultrasound experts blinded to group allocation rated the scans using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. RESULTS: During the 2 months of clinical training, participants in the intervention and control groups completed an average ± SD of 58 ± 41 and 63 ± 47 scans, respectively (P = 0.67). In the subsequent clinical performance test, the intervention group achieved higher OSAUS scores than did the control group (mean score, 59.1% vs 37.6%, respectively; P < 0.001). A greater proportion of the intervention group passed a pre-established pass/fail level than did controls (85.7% vs 8.3%, respectively; P < 0.001). CONCLUSION: Simulation-based ultrasound training leads to substantial improvement in clinical performance that is sustained after 2 months of clinical training. © 2015 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

Reliable and valid assessment of ultrasound operator competence in obstetrics and gynecology.

OBJECTIVES: To explore the reliability and validity of a recently developed instrument for assessment of ultrasound operator competence, the Objective Structured Assessment of Ultrasound Skills (OSAUS). METHODS: Three groups of 10 doctors with different levels of ultrasound experience in obstetrics and gynecology were included. The novices had less than 1 month of experience, the intermediate group had 12-60 months of experience and the senior participants were all consultants. Fifteen participants performed transabdominal fetal biometry and the other 15 participants performed systematic transvaginal gynecological ultrasound scans. All scans were video-recorded and assessed by two blinded consultants using the OSAUS scale. The OSAUS scores were compared between the groups using the Kruskal-Wallis test, and pass/fail scores were determined using the contrasting-groups method of standard setting. RESULTS: For the transabdominal fetal biometry examinations, the mean ± SD OSAUS scores of the novices, intermediates and senior participants were 1.5 ± 0.4, 3.3 ± 0.6 and 4.4 ± 0.4, respectively (P = 0.003). For the systematic transvaginal scans, the mean ± SD OSAUS scores of the novices, intermediates and senior participants were 1.8 ± 0.2, 3.1 ± 0.1 and 3.9 ± 0.5, respectively (P = 0.003). Post-hoc comparisons showed significant differences between each of the groups for both types of scans. The pass/fail score was 2.5 for the transvaginal scan and 3.0 for the transabdominal biometry examinations. The inter-rater reliability was 0.89. CONCLUSIONS: Ultrasound competence can be assessed in a reliable and valid way using the OSAUS scale. The pass/fail scores may be used to help determine when trainees are qualified for independent practice.

Value of endometrial thickness measurement for diagnosing focal intrauterine pathology in women without abnormal uterine bleeding.

OBJECTIVE: To assess the diagnostic value of transvaginal sonographic (TVS) measurement of endometrial thickness for diagnosing focal intrauterine pathology in women without abnormal uterine bleeding (AUB). METHODS: A random selection from the Danish Civil Registration System was made: 1660 women aged 20-74 years were invited to participate and 686 women were eligible and accepted inclusion (429 pre- and 257 postmenopausal). The women underwent TVS measurement of endometrial thickness and saline contrast sonohysterography (SCSH). Hysteroscopic resection with histopathology (gold standard) was performed when focal intrauterine pathology was suspected at SCSH. We excluded women with AUB (n = 237), failure of SCSH (n = 50), a scan that was not in the follicular phase (n = 11), hysteroscopy contraindicated (n = 2), and users of sequential hormone therapy (n = 9) or selective estrogen receptor modulators (n = 2). Thus, 375 women without AUB were included (217 pre- and 158 postmenopausal). Receiver-operating characteristics (ROC) curves for endometrial thickness and focal lesion were analyzed. RESULTS: Focal intrauterine pathology was confirmed in 41 women (35 with polyps, five with submucosal myomas and one with polypoidal growing cancer). For premenopausal women, the area under the ROC curve (AUC) was 0.79 (95% CI, 0.68-0.89) and for postmenopausal women it was 0.84 (95% CI, 0.76-0.92). For premenopausal women, the best negative likelihood ratio (LR- = 0.11) was obtained at an endometrial thickness of 5.2 mm, with a negative predictive value (NPV) of 99% and a positive predictive value (PPV) of 10%. For postmenopausal women the best LR- (0.08) was obtained at an endometrial thickness of 2.8 mm, with a NPV of 99% and a PPV of 26%. CONCLUSIONS: In women without AUB, TVS measurement of endometrial thickness is a poor diagnostic test, but is apparently efficacious in excluding focal intrauterine pathology, especially in postmenopausal women. The 4-5-mm threshold conventionally used to exclude endometrial malignancy in women with postmenopausal bleeding is not transferable to women without AUB for excluding focal intrauterine pathology.

Prevalence of endometrial polyps and abnormal uterine bleeding in a Danish population aged 20-74 years.

OBJECTIVE: To estimate the prevalence of endometrial polyps and to investigate associated abnormal uterine bleeding in a Danish population aged 20-74 years. METHODS: This was a study of a random selection of women from the Danish Civil Registration System: 1660 women were invited of whom 686 were included (429 pre- and 257 postmenopausal). AUB was assessed by a validated questionnaire. The women underwent transvaginal sonography (TVS) and saline contrast sonohysterography (SCSH). Hysteroscopic resection was performed in cases with suspected focal intrauterine pathology. Full evaluation was performed in 619 women (two failures of TVS and 60 failures of SCSH, in two women SCSH was contraindicated (endometrial cancer), in two women hysteroscopy was contraindicated, and one polyp was lost before histology). World Health Organization histopathological criteria were used for diagnosing true endometrial polyps. RESULTS: On final diagnosis there were 48 women with polyps, eight with submucosal myomas, four with other benign findings and one with polypoidal growing endometrial cancer. Complex hyperplasia without atypia was diagnosed in two women with polyps. The prevalence of endometrial polyps was 7.8% (48/619; 95% CI, 5.6-9.9%). The prevalence was influenced significantly by age (P<0.005); in women below the age of 30 years, the prevalence was 0.9%. Polyps were diagnosed in 5.8% of pre- and 11.8% of postmenopausal women (P<0.01). Thirty-nine (82%) of the women who had histopathologically verified polyps were asymptomatic. In asymptomatic premenopausal women the prevalence of polyps was 7.6%, while it was 13% in asymptomatic postmenopausal women. AUB, in particular intermenstrual bleeding, was more frequent among women without polyps (38%). By ultrasound examination, submucosal myomas were diagnosed in 4.2% (26/622; 95% CI, 2.6-5.8%) and intramural myomas in 11.1% (76/684; 95% CI, 8.8-13.5%) of women. Polyps were diagnosed in 2% of oral-contraceptive and 25% of hormone-therapy users. CONCLUSIONS: The overall prevalence of endometrial polyps was 7.8% and the prevalence increased with age. Polyps were rare (0.9%) in women below the age of 30 years. Surprisingly, AUB was less frequent among women with polyps than among those without polyps.

Completeness and accuracy of voluntary reporting to a national case registry of laparoscopic cholecystectomy.

OBJECTIVE: To validate completeness and accuracy of registry data reported from three randomly chosen departments contributing to The Danish National Registry of Laparoscopic Cholecystectomy, covering all departments offering chole cystectomy. DATA SOURCES: A total of 431 case reports representing cases of laparoscopic cholecystectomy in a 2-year period in three surgical departments. DESIGN: Comparison of case reports with reported data in The Danish National Registry of Laparoscopic Cholecystectomy. MAIN OUTCOME MEASURES: Rates of discrepancies, comparison of complication rates for cases in the registry and cases not reported to the registry. RESULTS: Completeness of registration was 69%, 80% and 99% respectively. A significantly higher degree of completeness was found in the only department with a formalized registration procedure. Inaccuracies were found in 28-49% of the cases, but none regarding serious complications such as bile duct injury or perioperative death. CONCLUSIONS: The information in the national registry may be accurate if the present findings can be extrapolated to the remaining departments in the country. The number of non-reported cases should be minimized by introducing a formalized procedure of handling and forwarding information to the registry. Continuous validation through external visits by registry staff to contributing departments may also be advisable.