Benchmarking of surgical complications in gynaecological oncology: prospective multicentre study.

OBJECTIVE: To explore the impact of risk-adjustment on surgical complication rates (CRs) for benchmarking gynaecological oncology centres. DESIGN: Prospective cohort study. SETTING: Ten UK accredited gynaecological oncology centres. POPULATION: Women undergoing major surgery on a gynaecological oncology operating list. METHODS: Patient co-morbidity, surgical procedures and intra-operative (IntraOp) complications were recorded contemporaneously by surgeons for 2948 major surgical procedures. Postoperative (PostOp) complications were collected from hospitals and patients. Risk-prediction models for IntraOp and PostOp complications were created using penalised (lasso) logistic regression using over 30 potential patient/surgical risk factors. MAIN OUTCOME MEASURES: Observed and risk-adjusted IntraOp and PostOp CRs for individual hospitals were calculated. Benchmarking using colour-coded funnel plots and observed-to-expected ratios was undertaken. RESULTS: Overall, IntraOp CR was 4.7% (95% CI 4.0-5.6) and PostOp CR was 25.7% (95% CI 23.7-28.2). The observed CRs for all hospitals were under the upper 95% control limit for both IntraOp and PostOp funnel plots. Risk-adjustment and use of observed-to-expected ratio resulted in one hospital moving to the >95-98% CI (red) band for IntraOp CRs. Use of only hospital-reported data for PostOp CRs would have resulted in one hospital being unfairly allocated to the red band. There was little concordance between IntraOp and PostOp CRs. CONCLUSION: The funnel plots and overall IntraOp (≈5%) and PostOp (≈26%) CRs could be used for benchmarking gynaecological oncology centres. Hospital benchmarking using risk-adjusted CRs allows fairer institutional comparison. IntraOp and PostOp CRs are best assessed separately. As hospital under-reporting is common for postoperative complications, use of patient-reported outcomes is important. TWEETABLE ABSTRACT: Risk-adjusted benchmarking of surgical complications for ten UK gynaecological oncology centres allows fairer comparison.

Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications).

BACKGROUND: There are limited data on surgical outcomes in gynaecological oncology. We report on predictors of complications in a multicentre prospective study. METHODS: Data on surgical procedures and resulting complications were contemporaneously recorded on consented patients in 10 participating UK gynaecological cancer centres. Patients were sent follow-up letters to capture any further complications. Post-operative (Post-op) complications were graded (I-V) in increasing severity using the Clavien-Dindo system. Grade I complications were excluded from the analysis. Univariable and multivariable regression was used to identify predictors of complications using all surgery for intra-operative (Intra-op) and only those with both hospital and patient-reported data for Post-op complications. RESULTS: Prospective data were available on 2948 major operations undertaken between April 2010 and February 2012. Median age was 62 years, with 35% obese and 20.4% ASA grade ⩾3. Consultant gynaecological oncologists performed 74.3% of operations. Intra-op complications were reported in 139 of 2948 and Grade II-V Post-op complications in 379 of 1462 surgeries. The predictors of risk were different for Intra-op and Post-op complications. For Intra-op complications, previous abdominal surgery, metabolic/endocrine disorders (excluding diabetes), surgical complexity and final diagnosis were significant in univariable and multivariable regression (P<0.05), with diabetes only in multivariable regression (P=0.006). For Post-op complications, age, comorbidity status, diabetes, surgical approach, duration of surgery, and final diagnosis were significant in both univariable and multivariable regression (P<0.05). CONCLUSIONS: This multicentre prospective audit benchmarks the considerable morbidity associated with gynaecological oncology surgery. There are significant patient and surgical factors that influence this risk.

Patient-reporting improves estimates of postoperative complication rates: a prospective cohort study in gynaecological oncology.

BACKGROUND: Most studies use hospital data to calculate postoperative complication rates (PCRs). We report on improving PCR estimates through use of patient-reporting. METHODS: A prospective cohort study of major surgery performed at 10 UK gynaecological cancer centres was undertaken. Hospitals entered the data contemporaneously into an online database. Patients were sent follow-up letters to capture postoperative complications. Grade II-V (Clavien-Dindo classification) patient-reported postoperative complications were verified from hospital records. Postoperative complication rate was defined as the proportion of surgeries with a Grade II-V postoperative complication. RESULTS: Patient replies were received for 1462 (68%) of 2152 surgeries undertaken between April 2010 and February 2012. Overall, 452 Grade II-V (402 II, 50 III-V) complications were reported in 379 of the 1462 surgeries. This included 172 surgeries with 200 hospital-reported complications and 231 with 280 patient-reported complications. All (100% concordance) 36 Grade III-V and 158 of 280 (56.4% concordance) Grade II patient-reported complications were verified on hospital case-note review. The PCR using hospital-reported data was 11.8% (172 out of 1462; 95% CI 11-14), patient-reported was 15.8% (231 out of 1462; 95% CI 14-17.8), hospital and verified patient-reported was 19.4% (283 out of 1462; 95% CI 17.4-21.4) and all data were 25.9% (379 out of 1462; 95% CI 24-28). After excluding Grade II complications, the hospital and patient verified Grade III-V PCR was 3.3% (48 out of 1462; 95% CI 2.5-4.3). CONCLUSION: This is the first prospective study of postoperative complications we are aware of in gynaecological oncology to include the patient-reported data. Patient-reporting is invaluable for obtaining complete information on postoperative complications. Primary care case-note review is likely to improve verification rates of patient-reported Grade II complications.

Accuracy of ultrasound subjective 'pattern recognition' for the diagnosis of borderline ovarian tumors.

OBJECTIVES: To assess the value of pattern recognition for the preoperative ultrasound diagnosis of borderline ovarian tumors (BOTs). METHODS: This was a prospective study of women who were referred to our regional cancer center with the diagnosis of an adnexal mass on a Level II (routine) gynecological ultrasound scan. Women with lesions of uncertain nature were referred for a Level III (expert) ultrasound scan in our tertiary center. The tumor pattern recognition method was used to differentiate between various types of ovarian tumors. Morphological features suggestive of BOTs were: unilocular cyst with a positive ovarian crescent sign and extensive papillary projections arising from the inner wall, or a cyst with a well defined multilocular nodule. The ultrasound findings were compared with the final histological diagnosis. RESULTS: A total of 224 women with an adnexal mass of uncertain nature were referred for an expert scan, 166 (74.1%) of whom underwent surgery. In this group of women the final histological diagnoses were: 99 (60%) benign lesions, 32 (19%) invasive ovarian cancer and 35 (21%) BOTs. Using pattern recognition combining the different morphological features, a correct preoperative diagnosis of BOT was made in 24/35 (68.6%) women: area under the receiver-operating characteristics curve 0.812 (standard error 0.049; 95% CI, 0.716-0.908), sensitivity 0.69 (95% CI, 0.52-0.81), specificity 0.94 (95% CI, 0.88-0.97), positive likelihood ratio 11.3 (95% CI, 5.53-22.8) and negative likelihood ratio 0.34 (95% CI, 0.21-0.55). CONCLUSIONS: Ultrasound diagnosis of BOTs is highly specific. However, typical features are absent in one-third of cases, which are typically misdiagnosed as benign lesions.

A comparative study of the risk of malignancy index and the ovarian crescent sign for the diagnosis of invasive ovarian cancer.

OBJECTIVE: To compare the value of the risk of malignancy index (RMI) and the ovarian crescent sign (OCS) in the diagnosis of ovarian malignancy. METHODS: This was a prospective observational study of women with ultrasonographic diagnosis of an ovarian cyst. The RMI was calculated in all cases using a previously published formula (RMI = U (ultrasound score) x M (menopausal status) x serum CA125 (kU/L)). A value > 200 was considered to be diagnostic of ovarian cancer. The OCS was defined as a rim of visible healthy ovarian tissue in the ipsilateral ovary. Its absence was taken as being diagnostic of invasive cancer. RESULTS: A total of 106 consecutive women were included in the study, of whom 92 (86.8%) had a benign ovarian tumor, five (4.7%) had borderline lesions and nine (8.5%) had an invasive ovarian cancer. The absence of an OCS diagnosed invasive ovarian cancer with a sensitivity of 100% (95% CI, 70-100%), specificity of 93% (95% CI, 86-96%), positive predictive value (PPV) of 56%, negative predictive value (NPV) of 100% and positive likelihood ratio (LR+) of 13.86 (95% CI, 6.79-28.29). This compared favorably with a sensitivity of 89% (95% CI, 57-98%), specificity of 92% (95% CI, 85-96%), PPV of 50%, NPV of 99% and LR+ of 10.78 (95% CI, 5.34-21.77), which were achieved using RMI > 200 (P < 0.01). CONCLUSIONS: The RMI and the OCS are useful tests for discriminating between invasive and non-invasive ovarian tumors. The application of these tests in a sequential manner might improve the overall accuracy of ovarian cancer diagnosis.

Expectant management of miscarriage--prediction of outcome using ultrasound and novel biochemical markers.

BACKGROUND: The aim of this study was to examine the value of various ultrasound and biochemical parameters for the prediction of successful expectant management of miscarriage. METHODS: This was a prospective observational study. Clinically stable women with an ultrasound diagnosis of miscarriage were offered expectant management. In all cases, gestational age, size of retained products of conception, serum HCG, progesterone, 17-hydroxyprogesterone, insulin growth factor-binding protein 1 (IGFBP-1), inhibin A and inhibin pro alpha-C RI levels were recorded. Follow-up continued until resolution of the pregnancy. Clinical data, ultrasound findings and biochemical markers were analysed using univariate analysis and decision tree analysis. RESULTS: Fifty-four women underwent expectant management of miscarriage. Thirty-seven (69%) had successful expectant management and 17 (31%) required surgery. The size of retained products, serum HCG, progesterone, inhibin A and inhibin pro alpha-C RI were all significantly different in those pregnancies that resolved spontaneously (P<0.05). Serum inhibin A was the best predictor of a complete miscarriage. CONCLUSION: This study shows that novel biochemical markers may be used to predict the likelihood of successful expectant management of miscarriage.

The value of detection of normal ovarian tissue (the 'ovarian crescent sign') in the differential diagnosis of adnexal masses.

OBJECTIVE: The aim of the study was to evaluate whether the presence of normal ovarian tissue adjacent to an adnexal tumor (the 'ovarian crescent sign') could assist in the preoperative differential diagnosis of adnexal lesions. METHODS: This was a prospective observational study including 100 women with a preoperative diagnosis of an adnexal mass. Demographic and biochemical data were collected and all women underwent a detailed transvaginal ultrasound scan. Tumor volume, morphological characteristics and Doppler features were recorded in each case. In addition, the tissue adjacent to the cyst was systematically examined for the presence of normal ovarian tissue. All the findings were compared to the final histological diagnosis. RESULTS: Sixty-seven (67%) of the cysts removed were benign, nine (9%) were borderline and 24 (24%) women had invasive malignant lesions. Normal ovarian tissue was seen in 58/76 (76%) women with non-invasive lesions, and in one woman (4%) with an invasive malignancy. In the absence of normal ovarian tissue, ovarian cancer was diagnosed with a sensitivity of 96% and specificity of 76%. CONCLUSION: The presence of normal ovarian tissue adjacent to an ovarian cyst is a useful morphological feature that may be used to help exclude an invasive ovarian malignancy in women with adnexal masses detected on ultrasound scan.

Expectant management of tubal ectopic pregnancy: prediction of successful outcome using decision tree analysis.

OBJECTIVE: To establish whether a decision tree based on a combination of clinical, morphological and biochemical parameters could be constructed to help in the selection of women with tubal ectopic pregnancies for expectant management. METHODS: This was a prospective observational study in a tertiary referral early pregnancy unit in an inner city teaching hospital. The study group consisted of 179 women with ultrasound diagnosis of ectopic pregnancy. Demographic, clinical and ultrasound data were recorded in each case at the initial visit. In addition all women had a blood sample taken for the measurements of serum beta-human chorionic gonadotropin (beta-hCG) and progesterone. Clinically stable women with non-viable pregnancies and no signs of hematoperitoneum were managed expectantly on an outpatient basis until their serum beta-hCG declined to <20 IU/L. Women who developed pelvic pain during follow-up and those with non-declining serum beta-hCG were offered surgery. RESULTS: A total of 107/179 (59.8%) tubal ectopics were considered suitable for expectant management. Ectopic pregnancy resolved spontaneously in 75/107 (70%) women, which was 41.9% of the total number of tubal ectopics. Maternal age, initial serum beta-hCG and progesterone were all significantly different in pregnancies that resolved spontaneously compared to those requiring surgery (P < 0.05). Initial serum beta-hCG level was the best predictor of the outcome of expectant management. These differences enabled a construction of a four-level decision tree to estimate the likelihood of successful expectant management. CONCLUSIONS: There are significant differences in demographic, ultrasound and biochemical findings between spontaneously resolving ectopics and those requiring treatment. Decision tree analysis may be used as a guide to estimate the probability of successful expectant management in individual cases.

First-trimester diagnosis and management of pregnancies implanted into the lower uterine segment Cesarean section scar.

OBJECTIVE: To describe first-trimester ultrasound diagnosis and management of pregnancies implanted into uterine Cesarean section scars. METHODS: All women referred for an ultrasound scan because of suspected early pregnancy complications were screened for pregnancies implanted into a previous Cesarean section scar. The management of Cesarean section scar pregnancies included transvaginal surgical evacuation, medical treatment with local injection of 25 mg methotrexate into the exocelomic cavity and expectant management. RESULTS: Eighteen Cesarean section scar pregnancies were diagnosed in a 4-year period. The prevalence in the local population was 1 : 1800 pregnancies. Surgical treatment was used in eight women and it was successful in all cases. The respective success rates of medical treatment and expectant management were 5/7 (71%) and 1/3 (33%). Five women (28%) required blood transfusion and one woman (6%) had a hysterectomy. CONCLUSIONS: Cesarean section scar pregnancies are more common than previously thought. When the diagnosis is made in the first trimester the prognosis is good and the risk of hysterectomy is relatively low.