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.

Less radical surgery for women with early stage cervical cancer: Our experience on radical vaginal trachelectomy and laparoscopic pelvic lymphadenectomy.

We report the use of radical vaginal trachelectomy (RVT) with pelvic laparoscopic lymphadenectomy (LPL) in patients with early stages cervical cancer (FIGO stage IA2-IB1). This is a case series prospectively collected over a 6-year period (2011-2017) at the Ipswich hospital, UK. Cases were compared to a group of women with a similar stage of cervical cancer, but treated with radical hysterectomy (RH) and pelvic lymphadenectomy (PL). A total of 19 patients (group 1) underwent RVT and LPL, and 51 (group 2) had RH and PL. We included: 5/19 (26%) stage IA2 and 14/19 (74%) stage IB1. Among those, we had: 12/19 (63%) cases of squamous cell carcinoma (SCC), 7/19(37%) of adenocarcinoma. Mean hospital stay was 2.7 days (range 2-4) in group 1 versus 4.8 days (range 3-8) group 2 (p-value = 0.173). The complication rate was not statistically different between the two groups 4/19(21%) and 7/51(14%) (p-value 0.169). The mean follow-up period was 47.3 months (range 7-78) in both groups. There were no cases of recurrence in group 1 and 2/51(4%) cases in group 2, but the difference was not significant (p-value = 0.497). In our experience RVT in well-selected patients is a safe treatment option with similar oncological outcomes when compared to patients undergoing more extensive surgery for the same early stage cervical cancer.

A case of incidental endometrial adenocarcinoma diagnosed in early pregnancy and managed conservatively.

We report a 29-year old nulliparous woman diagnosed with a grade 1 endometrioid adenocarcinoma of the endometrium arising from an atypical polypoid adenomyoma, while being investigated for a suspected threatened miscarriage at 7 weeks gestation. She presented complaining of vaginal bleeding and a small amount of soft tissue in the cervical os was found and sent for histology. An ultrasound scan was performed, which confirmed an intrauterine ongoing pregnancy. The patient had no further episodes of unscheduled bleeding. After the confirmed histological diagnosis an MRI scan was requested, and there were no evidence of myometrial invasion or distant metastasis. The patient was seen at each trimester, remained asymptomatic throughout the pregnancy and had a normal delivery at term. There was no evidence of any residual endometrioid adenocarcinoma in the post-delivery specimen. Six weeks post-natally an endometrial biopsy was performed, which was normal. She is still in remission over a period of 8 years follow-up. Endometrial adenocarcinoma in young pregnant women is a rare clinical circumstance. This case shows that conservative management in young women is possible including in a case of an incidental diagnosis in pregnancy.

Feasibility of screening for ovarian cancer using symptoms as selection criteria.

OBJECTIVE: Retrospective studies have reported that 95% of women with ovarian cancer have symptoms prior to diagnosis and that women with these symptoms are at an increased risk of ovarian cancer. Failure to recognise these symptoms may result in a delay in referral and diagnosis. We assess the feasibility of screening for ovarian cancer using symptoms as selection criteria. DESIGN: A randomised controlled trial. SETTING: General practices in East London. POPULATION: Three hundred and ninety GPs. METHODS: GPs were randomised by practice, and those in the study group were given rapid access to ultrasound and CA125 test for women, >45 years, suffering from symptoms that may be caused by ovarian cancer. MAIN OUTCOME MEASURES: Symptoms leading to referral, ultrasound and CA125 results and ovarian cancer diagnosis. RESULTS: Seventy nine practices containing 197 GPs were randomised to the study arm. Three hundred and seventeen women were referred, of which 315 were eligible. Women reported the following symptoms: abdominal 87%, gastrointestinal 41% and constitutional 29%. Twenty-three women had abnormal findings on ultrasound: 20 were managed conservatively and 3 surgically. Histology revealed a mucinous cystadenoma, a Brenner tumour and a serous cystadenoma. Incidental findings included endometrial pathology in 13 women and bladder pathology in 2. Ninety five percent of CA125 results were <35 units/ml. CONCLUSIONS: This pilot study confirms the feasibility of screening for ovarian cancer using symptoms as selection criteria. Specificity was high and patient compliance good. Initial concerns about referral volumes and additional investigations and referrals generated were not confirmed. No ovarian cancers were detected in this pilot study, and this may be due to the size of the cohort.

Differential diagnosis of adnexal masses: risk of malignancy index, ultrasonography, magnetic resonance imaging, and radioimmunoscintigraphy.

A risk of malignancy index (RMI), based on menopausal status, ultrasound (US) findings, and serum CA125, has previously been described and validated in the primary evaluation of women with adnexal masses and is widely used in selective referral of women from local cancer units to specialized cancer centers. Additional imaging modalities could be useful for further characterization of adnexal masses in this group of women. A prospective cohort study was conducted of 196 women with an adnexal mass referred to a teaching hospital for diagnosis and management. Follow-up data was obtained for 180 women; 119 women had benign and 61 women malignant adnexal masses. The sensitivity and specificity of specialist US, magnetic resonance imaging (MRI), radioimmunoscintigraphy (RS), and the RMI were determined. We identified a subgroup of women with RMI values of 25-1000 where the value of further specialist imaging was evaluated. Sensitivity and specificity for specialist US were 100% and 57%, for MRI 92% and 86%, and for RS 76% and 87%, respectively. Analysis of 123 patients managed sequentially, using RMI cutoff values of > or =25 and <1000 and then US and MRI provided a sensitivity of 94% and a specificity of 90%. Using this RMI cutoff followed by specialist US and MRI, as opposed to the traditional RMI cutoff value of 250, can increase the proportion of patients with cancer appropriately referred in to a cancer center, with no change in the proportion of patients with benign disease being managed in a local unit.