Cervical cancer and COVID-an assessment of the initial effect of the pandemic and subsequent projection of impact for women in England: A cohort study.

OBJECTIVE: To review the effect of the COVID-19 pandemic on the diagnosis of cervical cancer and model the impact on workload over the next 3 years. DESIGN: A retrospective, control, cohort study. SETTING: Six cancer centres in the North of England representing a combined population of 11.5 million. METHODS: Data were collected retrospectively for all diagnoses of cervical cancer during May-October 2019 (Pre-COVID cohort) and May-October 2020 (COVID cohort). Data were used to generate tools to forecast case numbers for the next 3 years. MAIN OUTCOME MEASURES: Histology, stage, presentation, onset of symptoms, investigation and type of treatment. Patients with recurrent disease were excluded. RESULTS: 406 patients were registered across the study periods; 233 in 2019 and 173 in 2020, representing a 25.7% (n = 60) reduction in absolute numbers of diagnoses. This was accounted for by a reduction in the number of low stage cases (104 in 2019 to 77 in 2020). Adding these data to the additional cases associated with a temporary cessation in screening during the pandemic allowed development of forecasts, suggesting that over the next 3 years there would be 586, 228 and 105 extra cases of local, regional and distant disease, respectively, throughout England. Projection tools suggest that increasing surgical capacity by two or three cases per month per centre would eradicate this excess by 12 months and 7 months, respectively. CONCLUSIONS: There is likely to be a significant increase in cervical cancer cases presenting over the next 3 years. Increased surgical capacity could mitigate this with little increase in morbidity or mortality. TWEETABLE ABSTRACT: Covid will result in 919 extra cases of cervical cancer in England alone. Effects can be mitigated by increasing surgical capacity.

Hormone replacement therapy after surgery for epithelial ovarian cancer.

BACKGROUND: Women who have undergone surgical treatment for epithelial ovarian cancer (EOC) may develop menopausal symptoms due to immediate loss of ovarian function following surgery and chemotherapy. Women may experience vasomotor symptoms, sleep disturbance, difficulty concentrating, sexual dysfunction, vaginal symptoms and accelerated osteoporosis. Although hormone replacement therapy (HRT) is the most effective treatment to relieve these symptoms, its safety has been questioned for women with EOC. OBJECTIVES: To assess the safety and efficacy of HRT for menopausal symptoms in women surgically treated for EOC. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 6), MEDLINE via Ovid (1946 to 12 June 2019) and Embase via Ovid (1980 to 2019, week 23). We also handsearched conference reports and trial registries. There was no language restriction. SELECTION CRITERIA: We included randomized controlled trials (RCTs) with participants of any age and menopausal status who had undergone surgery for EOC and, after diagnosis and treatment, used any regimen and duration of HRT compared with placebo or no hormone therapy. We also included trials comparing different regimens or duration of administration of HRT. DATA COLLECTION AND ANALYSIS: Two review authors independently identified studies that met the inclusion criteria. They used Covidence to extract study characteristics, outcome data and to assess methodological quality of the included studies. MAIN RESULTS: Our search strategy identified 2617 titles, of which 2614 titles were excluded. Three studies, involving 350 women, met our inclusion criteria. Two of the studies included pre and postmenopausal women, and the third only included premenopausal women. The overall age range of those women included in the studies was 20 to 89.6 years old, with a median follow-up ranging from 31.4 months to 19.1 years. The geographical distribution of participants included Europe, South Africa and China. All stages and histological subtypes were included in two of the studies, but stage IV disease had been excluded in the third. The three included studies used a variety of HRT regimens (conjugated oestrogen with or without medroxyprogesterone and with or without nylestriol) and HRT administrations (oral, patch and implant), In all studies, the comparisons were made versus women who had not received HRT. The studies were at low or unclear risk of selection and reporting bias, and at high risk of performance, detection and attrition bias. The certainty of the evidence was low for overall survival and progression-free survival, and very low for quality-of-life assessment, incidence of breast cancer, transient ischaemic attack (TIA), cerebrovascular accident (CVA) and myocardial infarction (MI). Meta-analysis of these studies showed that HRT may improve overall survival (hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.54 to 0.93; 350 participants, 3 studies; low-certainty evidence). Quality-of-life assessment by use of the EORTC-C30 questionnaire was performed only in one study. We are uncertain whether HRT improves or reduces quality of life as the certainty of the evidence was assessed as very low (mean difference (MD) 13.67 points higher, 95% CI 9.26 higher to 18.08 higher; 1 study; 75 participants; very low-certainty evidence). Likewise, HRT may make little or no difference to progression-free survival (HR 0.76, 95% CI 0.57 to 1.01; 275 participants, 2 studies; low-certainty evidence). We are uncertain whether HRT improves or reduces the incidence of breast cancer (risk ratio (RR) 2.00, 95% CI 0.19 to 21.59; 225 participants, 2 studies; very low-certainty evidence); TIA (RR 5.00, 95% CI 0.24 to 102.42; 150 participants, 1 study; very low-certainty evidence); CVA (RR 0.67, 95% CI 0.11 to 3.88; 150 participants, 1 study; very low-certainty evidence); and MI (RR 0.20, 95% CI 0.01 to 4.10; 150 participants, 1 study; very low-certainty evidence). The incidence of gallstones was not reported in the included studies. AUTHORS' CONCLUSIONS: Hormone replacement therapy may slightly improve overall survival in women who have undergone surgical treatment for EOC, but the certainty of the evidence is low. HRT may make little or no difference to quality of life, incidence of breast cancer, TIA, CVA and MI as the certainty of the evidence has been assessed as very low. There may be little or no effect of HRT use on progression-free survival. The evidence in this review is limited by imprecision and incompleteness of reported relevant outcomes and therefore the results should be interpreted with caution. Future well-designed RCTs are required as this is an important area to women experiencing menopausal symptoms following surgical treatment for ovarian cancer, especially as doctors are often reluctant to prescribe HRT in this scenario. The evidence in this review is too limited to support or refute that HRT is very harmful in this population.

Association of elevated pre-operative HbA1c and post-operative complications in patients undergoing gynaecological oncology surgery.

HbA1c testing provides average blood glucose control, an elevated result may be associated with adverse post-operative outcomes. Our objective was to evaluate the association between elevated pre-operative HbA1c and post-operative complications in patients undergoing major gynaecological oncology surgery. HbA1c was measured pre-operatively in 364 patients. We identified 65 (16%) patients at risk of developing diabetes with borderline HbA1c measurements.Patients with borderline HbA1c (42-47 mmol/mol) had almost double the incidence of infections compared to patients with normal HbA1c (15.8% vs. 6.5%, p=.038). There were significantly less infections between patients with a normal HbA1c (<42 mmol/mol) and those with an HbA1c of over 42 mmol/mol (6.5% vs. 22.8%, p<.05). There was an association between elevated HbA1c and infective complications especially in patients with a borderline HbA1c. It is suggested that knowing HbA1c status, intervention can be made to prevent post-operative infective complications and improve outcomes.Impact statementWhat is already known on this subject? Obesity is a common risk factor for gynaecological cancer and elevated HbA1c. Chronically elevated HbA1c may lower immunity. An association has been shown previously between elevated HbA1c and post-operative complications.What the results of this study add? This study examined infective complications in patients undergoing gynaecological surgery; showing that patients with a borderline HbA1c (42-47 mmol/mol), especially those with a diagnosis of diabetes to be most at risk. This suggests that pre-operative HbA1c should be used routinely to guide care rather than diabetic status alone to prevent post-operative infections.What the implications are of these findings for clinical practice and/or further research? More research needs to be carried out to find the optimal pre-operative HbA1c targets to reduce post-operative infection rates. Work needs to be done in conjunction with general practitioners to help patients to reduce their HbA1c prior to treatment.

Impact of surgical site infection (SSI) following gynaecological cancer surgery in the UK: a trainee-led multicentre audit and service evaluation.

OBJECTIVES: Surgical site infection (SSI) complicates 5% of all surgical procedures in the UK and is a major cause of postoperative morbidity and a substantial drain on healthcare resources. Little is known about the incidence of SSI and its consequences in women undergoing surgery for gynaecological cancer. Our aim was to perform the first national audit of SSI following gynaecological cancer surgery through the establishment of a UK-wide trainee-led research network. DESIGN AND SETTING: In a prospective audit, we collected data from all women undergoing laparotomy for suspected gynaecological cancer at 12 specialist oncology centres in the UK during an 8-week period in 2015. Clinicopathological data were collected, and wound complications and their sequelae were recorded during the 30 days following surgery. RESULTS: In total, 339 women underwent laparotomy for suspected gynaecological cancer during the study period. A clinical diagnosis of SSI was made in 54 (16%) women. 33% (18/54) of women with SSI had prolonged hospital stays, and 11/37 (29%) had their adjuvant treatment delayed or cancelled. Multivariate analysis found body mass index (BMI) was the strongest risk factor for SSI (OR 1.08[95% CI 1.03 to 1.14] per 1 kg/m2 increase in BMI [p=0.001]). Wound drains (OR 2.92[95% CI 1.41 to 6.04], p=0.004) and staple closure (OR 3.13[95% CI 1.50 to 6.56], p=0.002) were also associated with increased risk of SSI. CONCLUSIONS: SSI is common in women undergoing surgery for gynaecological cancer leading to delays in discharge and adjuvant treatment. Resultant delays in adjuvant treatment may impact cancer-specific survival rates. Modifiable factors, such as choice of wound closure material, offer opportunities for reducing SSI and reducing morbidity in these women. There is a clear need for new trials in SSI prevention in this patient group; our trainee-led initiative provides a platform for their successful completion.

The Role of Ultrasound Simulation in Obstetrics and Gynecology Training: A UK Trainees' Perspective.

INTRODUCTION: Ultrasonography is a core skill required by all obstetrics and gynecology trainees; however, training opportunities in clinical ultrasound are declining. Simulation ultrasound training has been proposed as a strategy to overcome this.The study aims were to determine the current availability of clinical and simulation ultrasound training in obstetrics and gynecology in the United Kingdom and to explore the trainees' perspective on the role of ultrasound simulation. METHODS: All obstetrics and gynecology trainees within the East Midlands Local Education Training Board in the United Kingdom were asked to complete an anonymous web-based survey in July 2014. RESULTS: Of 140 trainees, 70 (50%) responded to the survey, and 69% reported rarely having dedicated clinical ultrasound sessions. Fifty percent had failed to achieve ultrasound competencies required for their stage of training, and 83% felt that the pressures of service provision limited their exposure to clinical ultrasound.Seventy-three percent of the trainees considered ultrasound simulation to be an essential component of training, and 69% agreed that it would help improve their clinical skills. Only 50% had access to an ultrasound simulator. Seventy-seven percent of the trainees thought that it would be useful to have ultrasound simulation integrated into training. CONCLUSIONS: Trainees are struggling to achieve minimal ultrasound competences with clinical ultrasound training alone. They believe that ultrasound simulation will shorten the learning curve and improve their clinical skills and knowledge. Despite the cost implications of simulation training, we propose that consideration is given to formal integration of ultrasound simulation into the curriculum as a possible way forward.

The Use of the Colposcopically Directed Punch Biopsy in Clinical Practice: A Survey of British Society of Colposcopy and Cervical Pathology (BSCCP)-Accredited Colposcopists.

OBJECTIVES: The colposcopically directed punch biopsy has been an integral component of colposcopic practice. In light of the changing landscape of the cervical screening programme, a study was conducted to investigate the current practice of British Society of Colposcopy and Cervical Pathology-accredited colposcopists on technique and rationale for performing a punch biopsy. MATERIALS AND METHODS: A web-based questionnaire survey was e-mailed to all British Society of Colposcopy and Cervical Pathology-accredited colposcopists. Questions included selection criteria for performing a punch biopsy, number of biopsies, and technique. Results were analyzed by specialty, experience, and workload. RESULTS: A total of 749 colposcopists responded, 50.2% of the 1,493 total. The respondents were obstetrician and gynecologists (42.9%), gynecologists/oncologists (33.6%), and nurse colposcopists (19.8%). Most colposcopists (78.3%) had more than 5-year colposcopy experience and saw in excess of 11 new cases (73.4%) of abnormal cervical cytology/month. Most colposcopists (56%) aimed to take 2 biopsies to diagnose cervical intraepithelial neoplasia, and very few (16.2%) reported routinely taking random biopsies from normal areas of cervix. Looking at the trends in management in the case scenarios, there was a lower threshold for performing punch biopsy before large loop excision of the transformation zone in younger (age, <25 years) or nulliparous women versus older women (age, >40 years; p < .05). Colposcopists were more likely to take biopsies in women with low-grade cytology/colposcopic findings (71.2%, always or most of the times) as compared with high-grade cytology/colposcopic findings (40.3%, never or rarely). CONCLUSIONS: Colposcopically directed punch biopsy is routinely used by colposcopists; however, techniques, number of biopsies taken, and rationale for performing a biopsy vary greatly between colposcopists.

Implementation of enhanced recovery after surgery (ERAS) in gynaecological oncology.

OBJECTIVES: To evaluate the outcomes of enhanced recovery after surgery (ERAS) implementation in a gynaecological oncology centre. METHOD: Non-randomised control trial, evaluating morbidity outcomes, before and after implementation of ERAS programme. All consecutive major gynaecological oncology operations performed during two specified periods were included. Data were collected prospectively for a study group in the initial 7.5 months of ERAS implementation and compared with a consecutive historic control group from the exact same period, the year before. Patients' characteristics and perioperative outcomes were compared. Further analysis stratified abdominal and laparoscopic surgery. RESULTS: In total, 265 cases identified; 99 patients followed ERAS and 99 historic controls, managed with a traditional peri-operative approach, the exact same period the year before (vulval surgery excluded, 67 cases). Groups were comparable in demographics and co-morbidities (age, BMI, ASA, WHO), level of surgery and 30 days post-operative complication (grading Clavien-Dindo classification) and readmission rates (p > 0.05). Overall, the post-operative length of hospital stay (LOS) was significantly reduced for patients who followed ERAS (4.29 ± 2.78 days versus 7.23 ± 5.68 days, p < 0.001). Stratification to subgroups was based on the type of surgery, abdominal versus laparoscopic. Those who underwent abdominal surgery and followed ERAS benefited the maximum (LOS: 5.09 ± 2.74 days versus 8.70 ± 5.75, p < 0.001) CONCLUSIONS: ERAS programme is feasible and safe in Gynae-oncology. In this study, there was a reduction of 3.61 (SE: 0.78, CI 95 %) days in the total LOS, in major abdominal Gynae-oncology surgery (level 3 and 4) without affecting complication or readmission rates.

Prognostic value of preoperative Ca125 and Tag72 serum levels and their correlation to disease relapse and survival in endometrial cancer.

OBJECTIVE: To evaluate preoperative serum levels of Ca125 and Tag72-4 tumour markers and investigate if abnormal levels correlate to mortality and disease-free survival. METHOD: Retrospective observational study of a cohort of 282 women (mean age 62.3, SD 10.5 years) with primary endometrial cancer included all consecutive cases treated in a tertiary Gynaecological oncology Center. Excluded cases with other cancer or previous cancer treatment, major abdominal pathology or inflammation, endometriosis. Preoperative serum Tag72 and Ca125 levels were determined and evaluated in relation to disease-free survival (DFS) and disease-specific overall survival (DOS). RESULTS: Raised Ca125 correlates to worse overall disease-specific survival (66.1 vs 87.8 months, p = 0.021) and Tag72 correlates to shorter disease-free survival (69.2 vs 67.3 months, p = 0.021) and higher recurrence rate (13.5 vs 6 %, p = 0.021). When both Ca125 and Tag72 are abnormal DFS and DOS are worse. 93.3 % (72.3 months) vs 82.4 %, (61.3 months) p = 0.018 and 96.3 % (74.8 months) vs 88.2 %, (65.9 months) p = 0.021, respectively. CONCLUSION: This study enhances the value of preoperative tumour markers and their prognostic value. Ca125 and Tag72 appear to be good predictors of poor prognosis in patients with endometrial cancer.

Primary bone metastasis as initial presentation of endometrial cancer (stage IVb).

INTRODUCTION: Endometrial cancer is the most common malignancy among females in developed countries. Abnormal uterine bleeding is the leading symptom in approximately 90 % of cases. The incidence of stage IV disease is approximately 5-10 % with a 5-year overall survival of less than 10 %. MATERIALS AND METHODS: A rare case presented with femoral pathological fracture and underlying endometrial cancer. We discuss the diagnosis, management and literature review for this extremely rare entity which can be present even in the absence of vaginal bleeding. RESULTS: Literature search revealed 28 cases with primary bone metastasis and all were symptomatic at the time of diagnosis. Eighty percent of them had tumour on the lower limb and the majority did not have vaginal bleeding. The predominant histopathological type was endometrioid (72.4 %) and grade 1-2 (59 %). Treatment had been individualised and 57 % of the cases underwent surgery with removal of uterus and adnexa and only three patients (10.7 %) received pelvic radiotherapy. Bone tumour was treated with radiotherapy in 80 % of the cases, alone (28 %), or combined with primary surgery (12 %) or chemotherapy (40 %). Overall, 54 % of patients received chemotherapy and 46 % received hormone therapy. The mean survival of patients who presented with single-bone metastasis was significantly better than those with multiple extrauterine metastatic sites: mean 85.7 months (SE: 9.2) versus 22.9 months (SE: 5.2), p < 0.003, CI 95 %. These two different survival patterns are more likely to reflect two different biological disease behaviours. Those with advanced local and widespread disease progress quicker, in contrast to those with a single-bone extrauterine metastatic site and local disease limited to the uterus, which continues to behave as early stage endometrial cancer. CONCLUSIONS: Although extremely rare, endometrial cancer can present as initial bone pathology. Endometrial biopsy should be included in the patient's workup when investigating for metastatic bone adenocarcinoma of unknown origin, even when gynaecological symptoms are lacking, as this rare presentation of stage IVb endometrial cancer appears to have good survival outcomes.

Can the preoperative Ca-125 level predict optimal cytoreduction in patients with advanced ovarian carcinoma? A single institution cohort study.

BACKGROUND: Preoperative Ca-125 level has been used as a predictor of optimal cytoreduction in advanced ovarian carcinoma. Yet, controversy exists regarding the ability of the tumor marker to predict optimal debulking and moreover of the proper cut-off limit to do so. METHODS: The preoperative Ca-125 levels of 426 patients with Stage III/IV ovarian carcinoma from a single institution were correlated with surgical outcome. Optimal was considered the cytoreduction if the largest residual tumor was < or equal to 1 cm in diameter. Receiver operation characteristic (ROC) curve data were combined with interval likelihood ratios at various Ca-125 levels to determine the cut-off level with the maximum prognostic power. Sensitivity, specificity, positive and negative predictive values and accuracy were also calculated. RESULTS: Preoperative Ca-125 proved to be a reliable predictor for optimal cytoreduction. The area under curve of the ROC curve was 0.89, 98% C.I.=[0.828-0.952], indicating very good discriminating capability. The level of 500 IU/ml was found to have the most predictive power. The sensitivity of Ca-125 at that level was 78.5%, the specificity 89.6%, the positive predictive value 84.2%, the negative predictive value 85.4% and its accuracy 85%. Furthermore, the likelihood ratio for correct discrimination between optimal and sub-optimal cytoreduction, dropped sharply from 6.33, 95% C.I. [5.19-10.91] at the level of 500 IU/ml to 0.58, 95% C.I. [0.21-1.63] at the level of 600 IU/ml. CONCLUSIONS: Our data indicate that preoperative Ca-125 is a good predictor for optimal cytoreduction. the best threshold for this prediction proved to be 500 IU/ml. These patients may be candidates for neo-adjuvant chemotherapy treatment. Nevertheless, all clinical and radiological findings must be co-evaluated.