Perspectives, fears and expectations of patients with gynaecological cancers during the COVID-19 pandemic: A Pan-European study of the European Network of Gynaecological Cancer Advocacy Groups (ENGAGe)

"Artículo escrito por un elevado número de autores, solo se referencian el que aparece en primer lugar, el nombre del grupo de colaboración, si le hubiere, y los autores pertenecientes a la UAM".Background: The impact of the COVID-19 pandemic on European gynaecological cancer patients under active treatment or follow-up has not been documented. We sought to capture the patient perceptions of the COVID-19 implications and the worldwide imposed treatment modifications. Methods: A patient survey was conducted in 16 European countries, using a new COVID-19-related questionnaire, developed by ENGAGe and the Hospital Anxiety & Depression Scale questionnaire (HADS). The survey was promoted by national patient advocacy groups and charitable organisations. Findings: We collected 1388 forms; 592 online and 796 hard-copy (May, 2020). We excluded 137 due to missing data. Median patients’ age was 55 years (range: 18–89), 54.7% had ovarian cancer and 15.5% were preoperative. Even though 73.2% of patients named cancer as a risk factor for COVID-19, only 17.5% were more afraid of COVID-19 than their cancer condition, with advanced age (>70 years) as the only significant risk factor for that. Overall, 71% were concerned about cancer progression if their treatment/follow-up was cancelled/postponed. Most patients (64%) had their care continued as planned, but 72.3% (n = 892) said that they received no information around overall COVID-19 infection rates of patients and staff, testing or measures taken in their treating hospital. Mean HADS Anxiety and Depression Scores were 8.8 (range: 5.3–12) and 8.1 (range: 3.8–13.4), respectively. Multivariate analysis identified high HADS-depression scores, having experienced modifications of care due to the pandemic and concern about not being able to visit their doctor as independent predictors of patients’ anxiety. Interpretation: Gynaecological cancer patients expressed significant anxiety about progression of their disease due to modifications of care related to the COVID-19 pandemic and wished to pursue their treatment as planned despite the associated risks. Healthcare professionals should take this into consideration when making decisions that impact patients care in times of crisis and to develop initiatives to improve patients’ communication and education

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Low-Volume Nodal Metastasis in Endometrial Cancer: Risk Factors and Prognostic Significance

Objective: To evaluate the oncological outcomes of patients with low-volume metastasis compared to those with macrometastasis and negative nodes in endometrial cancer. Methods: A single institutional retrospective study was carried out, which included all patients with endometrial cancer who underwent surgical treatment between January 2007 and December 2016. We analyzed the progression-free survival (PFS) and overall survival (OS) of all patients after sentinel node biopsy and full nodal surgical staging according to their final pathological nodal status, focusing on the impact of the size of nodal metastasis. Results: A total of 270 patients were operated on during the study period; among them, 230 (85.2%) patients underwent nodal staging. On final pathology, 196 (85.2%) patients had negative lymph nodes; low-volume metastasis (LVM) was present in 14 (6.1%) patients: 6 (2.6%) patients had isolated tumor cells (ITCs) and 8 (3.5%) patients presented just micrometastasis; additionally, 20 (8.7%) patients presented macrometastasis. After a median (range) follow-up of 60 (0–146) months, patients with macrometastasis showed a significantly worse PFS compared to LVM and node-negative patients (61.1% vs. 71.4% vs. 83.2%, respectively; p = 0.018), and similar results were obtained for 5-year OS (50% vs. 78.6% vs. 81.5%, respectively; p < 0.001). Half of the patients presenting LVM did not receive adjuvant treatment. Moreover, LVM had a moderate nonsignificant decrease in 5-year PFS compared to node-negative patients. Conclusions: Patients with endometrial cancer and low-volume nodal metastasis demonstrated a better prognosis than those presenting macrometastasis. Low-volume metastasis did not show worse oncological outcomes than node-negative patients, although there was a slight decrease in progression-free survival

Safety and patients’ satisfaction after hysteroscopic sterilisation

The aim of this study was to understand the potential complications of the Essure® device as well as the factors influencing its onset and patient satisfaction. We present a 9-year descriptive prospective study that included 1068 patients. The device was placed in 1056 of them (98.8%); 894 had no pain or mild pain during the insertion and only 12 patients experienced pain greater than menstrual pain. The proportion of patients without pain was greater in the group that took NSAIDs or NSAIDs and BZD and the unmedicated group had the highest rate of severe pain (p = .00). In all, 161 of the 1064 patients who had the Essure® inserted reported having an adverse effect during the 3-months post-insertion (pelvic pain or discomfort). The mean score out of 10 attributed to this method was 9.06 (S = 1.11). We concluded that the Essure® shows a low rate of complications and users showed a high degree of satisfaction.Impact statement What is already known on this subject: There are few international publications on Essure®. When we conducted a search in PubMed for the term ‘Essure’, we obtained 221 publications. When we added the terms ‘Essure and complications’, we obtained 20 publications, and when we increased the restriction including ‘satisfaction’, we obtained seven; thus, the uniqueness of our study. What the results of this study add: We present a 9-year descriptive prospective study that included 1068 patients. The aim of this study was to understand the potential complications of the Essure® device (Bayer, Whippany, NJ), as well as factors that can influence its onset and the patient satisfaction. The device was placed in 1056 of the patients (98.8%); 894 had no pain or mild pain during the insertion and only 12 patients experienced pain greater than menstrual pain. The proportion of patients without pain was greater in the group that took NSAIDs or NSAIDs and BZD and the unmedicated group had the highest rate of severe pain (p=.00). What the implications are of these findings for clinical practice and/or further research: Our study shows a low rate of complications with Essure®, mild and transient in most cases, as well as a high degree satisfaction. Nevertheless, given the few published studies on this device, we believe that long-term follow-up is needed

Accuracy of detection rate and intraoperative sentinel lymph node assessment in early-stage cervical carcinoma

Objective: This article shows our experience on sentinel lymph node (SLN) biopsy in early-stage cervical carcinoma since the technique was introduced in our Institution. The main objective is to analyze the detection rate (DR) of metastatic SLNs, identifying prognostic factors for an increased risk of nodal metastases. Our second aim was to compare the accuracy of nodal metastases DR between intraoperative analysis and postoperative ultrastaging. Materials and Methods: Forty-one women with the International Federation of Gynecology and Obstetrics stages IA2-IIA1 who underwent laparoscopic surgical treatment applying the SLN technique, from December 2011 to June 2016, at La Paz University Hospital, were included. The sentinel node was identified using technetium and methylene blue dye or indocyanine green near-infrared fluorescent imaging, analyzed intraoperatively, and compared to deferred ultrastaging. Results: SLN DR was 100%, with a bilaterality rate of 83%. Twelve (26.8%) patients had metastatic nodes, 11 of them (91.7%) detected by SLN technique, of which 9 (81.8%) had only the sentinel node affected. False-negative rate was 2.4% after ultrastaging procedure. Metastatic SLN detection with ultrastaging was 45.5% higher than the intraoperative analysis, 63.6% of which had low tumor burden. The global detection of patients with nodal metastases after SLN technique was 21.9% higher than pelvic lymphadenectomy. Conclusions: Our preliminary results corroborate that SLN biopsy selectively maps metastatic nodes and ultrastaging increases the detection of metastatic SLNs, predominantly due to low tumor burden

Direct trocar insertion without previous pneumoperitoneum versus insertion after insufflation with Veress needle in laparoscopic gynecological surgery: a prospective cohort study

The aim of this study was to determine whether direct trocar entry without prior pneumoperitoneum at umbilical level (DTI) can be a safe alternative to access the abdominal cavity in gynaecological laparoscopic surgery. We present a prospective observational analytical study of cohorts, comparing DTI with umbilical entry with trocar after previous insufflation with a Veress needle at umbilical level (V). The study period was performed from June 2013 to April 2016; data was collected on 600 patients who underwent gynaecological laparoscopic surgery. There were no significant differences in the risk of suffering a complication during the access manoeuvres between DTI (6.49%) and V (7.39%), OR 0.89 (95% CI: 0.42–1.81). The duration of the access manoeuvres was 69 s in DTI and 193 s in V (p  .05). We concluded that DTI is at least as safe as V, regarding the risk of suffering complications arising from access into the abdominal cavity. DTI has advantages with regard to V, such as: the shorter duration of access manoeuvres or the lesser number of unsuccessful entry or insufflation attempts.Impact statement What is already known on this subject? There are few international publications comparing DTI and V. When we conducted a search in PubMed for the terms ‘Veress needle and direct trocar insertion’, 51 publications were obtained. When we increased the restriction and added the terms ‘laparoscopic entry and laparoscopy complications’, 27 publications were obtained; thus, the uniqueness of our study. What do the results of this study add? We present a 3-year observational prospective study of cohorts that included 600 patients. The aim of this study was to determine that in laparoscopic gynaecological surgery, DTI is an access method to the abdominal cavity at least as safe as V, with respect to the risk of complications. On the other hand, DTI has some advantages such as the shorter duration of access manoeuvres or the lower number of failed entry attempts. What are the implications of these findings for clinical practice and/or further research? Given the limited number of publications that compared both techniques, our study indicates that DTI can be a safe alternative for access to abdominal cavity in gynaecological surgery, compared to the traditional V

Effects of pre-operative isolation on postoperative pulmonary complications after elective surgery: an international prospective cohort study an international prospective cohort study

We aimed to determine the impact of pre-operative isolation on postoperative pulmonary complications after elective surgery during the global SARS-CoV-2 pandemic. We performed an international prospective cohort study including patients undergoing elective surgery in October 2020. Isolation was defined as the period before surgery during which patients did not leave their house or receive visitors from outside their household. The primary outcome was postoperative pulmonary complications, adjusted in multivariable models for measured confounders. Pre-defined sub-group analyses were performed for the primary outcome. A total of 96,454 patients from 114 countries were included and overall, 26,948 (27.9%) patients isolated before surgery. Postoperative pulmonary complications were recorded in 1947 (2.0%) patients of which 227 (11.7%) were associated with SARS-CoV-2 infection. Patients who isolated pre-operatively were older, had more respiratory comorbidities and were more commonly from areas of high SARS-CoV-2 incidence and high-income countries. Although the overall rates of postoperative pulmonary complications were similar in those that isolated and those that did not (2.1% vs 2.0%, respectively), isolation was associated with higher rates of postoperative pulmonary complications after adjustment (adjusted OR 1.20, 95%CI 1.05–1.36, p = 0.005). Sensitivity analyses revealed no further differences when patients were categorised by: pre-operative testing; use of COVID-19-free pathways; or community SARS-CoV-2 prevalence. The rate of postoperative pulmonary complications increased with periods of isolation longer than 3 days, with an OR (95%CI) at 4–7 days or ≥ 8 days of 1.25 (1.04–1.48), p = 0.015 and 1.31 (1.11–1.55), p = 0.001, respectively. Isolation before elective surgery might be associated with a small but clinically important increased risk of postoperative pulmonary complications. Longer periods of isolation showed no reduction in the risk of postoperative pulmonary complications. These findings have significant implications for global provision of elective surgical care. We aimed to determine the impact of pre-operative isolation on postoperative pulmonary complications after elective surgery during the global SARS-CoV-2 pandemic. We performed an international prospective cohort study including patients undergoing elective surgery in October 2020. Isolation was defined as the period before surgery during which patients did not leave their house or receive visitors from outside their household. The primary outcome was postoperative pulmonary complications, adjusted in multivariable models for measured confounders. Pre-defined sub-group analyses were performed for the primary outcome. A total of 96,454 patients from 114 countries were included and overall, 26,948 (27.9%) patients isolated before surgery. Postoperative pulmonary complications were recorded in 1947 (2.0%) patients of which 227 (11.7%) were associated with SARS-CoV-2 infection. Patients who isolated pre-operatively were older, had more respiratory comorbidities and were more commonly from areas of high SARS-CoV-2 incidence and high-income countries. Although the overall rates of postoperative pulmonary complications were similar in those that isolated and those that did not (2.1% vs 2.0%, respectively), isolation was associated with higher rates of postoperative pulmonary complications after adjustment (adjusted OR 1.20, 95%CI 1.05–1.36, p = 0.005). Sensitivity analyses revealed no further differences when patients were categorised by: pre-operative testing; use of COVID-19-free pathways; or community SARS-CoV-2 prevalence. The rate of postoperative pulmonary complications increased with periods of isolation longer than 3 days, with an OR (95%CI) at 4–7 days or ≥ 8 days of 1.25 (1.04–1.48), p = 0.015 and 1.31 (1.11–1.55), p = 0.001, respectively. Isolation before elective surgery might be associated with a small but clinically important increased risk of postoperative pulmonary complications. Longer periods of isolation showed no reduction in the risk of postoperative pulmonary complications. These findings have significant implications for global provision of elective surgical care