Author: Jason Curtis

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial (2021)

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Type of publication:
Randomised controlled trial

Author(s):
Devall A.; Chu J.; Beeson L.; Hardy P.; Cheed V.; Sun Y.; Roberts T.; Ogwulu C.O.; Williams E.; Jones L.; Papadopoulos J.F.; Bender-Atik R.; Brewin J.; Hinshaw K.; Choudhary M.; Ahmed A.; Naftalin J.; Nunes N.; Oliver A.; Izzat F.; Bhatia K.; Hassan I.; Jeve Y.; Hamilton J.; Deb S.; Bottomley C.; Ross J.; Watkins L.; *Underwood M.; Cheong Y.; Kumar C.; Gupta P.; Small R.; Pringle S.; Hodge F.; Shahid A.; Gallos I.; Horne A.; Quenby S.; Coomarasamy A.

Citation:

Health Technology Assessment, November 2021, 25(68) (pp 1-114)

Abstract:
TRIAL DESIGN: A randomised, parallel-group, double-blind, placebo-controlled multicentre study with health economic and nested qualitative studies to determine if mifepristone (Mifegyne, Exelgyn, Paris, France) plus misoprostol is superior to misoprostol alone for the resolution of missed miscarriage. METHOD(S): Women diagnosed with missed miscarriage in the first 14 weeks of pregnancy were randomly assigned (1:1 ratio) to receive 200mg of oral mifepristone or matched placebo, followed by 800mug of misoprostol 2 days later. A web-based randomisation system allocated the women to the two groups, with minimisation for age, body mass index, parity, gestational age, amount of bleeding and randomising centre. The primary outcome was failure to pass the gestational sac within 7 days after randomisation. The prespecified key secondary outcome was requirement for surgery to resolve the miscarriage. A within-trial cost-effectiveness study and a nested qualitative study were also conducted. Women who completed the trial protocol were purposively approached to take part in an interview to explore their satisfaction with and the acceptability of medical management of missed miscarriage. RESULT(S): A total of 711 women, from 28 hospitals in the UK, were randomised to receive either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 out of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 out of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group (risk ratio 0.73, 95% confidence interval 0.54 to 0.98; p=0.04). Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (risk ratio 0.70, 95% confidence interval 0.52 to 0.94; p=0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A total of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview. Women appeared to have a preference for active management of their miscarriage. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The use of mifepristone and misoprostol showed an absolute effect difference of 6.6% (95% confidence interval 0.7% to 12.5%). The average cost per woman was lower in the mifepristone plus misoprostol group, with a cost saving of 182 (95% confidence interval 26 to 338). Therefore, the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. LIMITATIONS: The results from this trial are not generalisable to women diagnosed with incomplete miscarriage and the study does not allow for a comparison with expectant or surgical management of miscarriage. FUTURE WORK: Future work should use existing data to assess and rank the relative clinical effectiveness and safety profiles for all methods of management of miscarriage. CONCLUSION(S): Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again. The mifepristone and misoprostol intervention was shown to be cost-effective in comparison to misoprostol alone.

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Myomectomy during cesarean section or non-caesarean myomectomy in reproductive surgery: This is the dilemma. (2021)

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Type of publication:
Journal article

Author(s):
Tinelli A.; Nezhat C.H.; Likic-Ladjevic I.; Andjic M.; Tomasevic D.; *Papoutsis D.; Stefanovic R.; Sparic R.

Citation:
Clinical and Experimental Obstetrics and Gynecology. December 2021, 48(6) (pp 1250-1258)

Abstract:
Nowadays it is quite common to encounter pregnants over 35 years with uterine fibroids (UFs), requiring cesarean section (CS). Large UFs may cause severe complications during delivery, as bleeding and hemorrhage, during vaginal or cesarean delivery. Frequently, the caesarean myomectomy (CM) is recommended, but generally obstetricians are reluctant to perform CM, since literature data do not agree on its surgical recommendation. CM is jet particularly controversial, due to increased risk of perioperative hemorrhage and cesarean hysterectomy, and UFs are often left in situ during cesarean section (CS). CM investigations are generally directed to myomectomy associated issues, whereas CS complications without CM are largely underreported. The risks of leaving UF for an interval myomectomy is underestimated and large UFs, left in uterus during CS, might cause significant early and late postoperative complications, even necessitating a relaparotomy and/or a subsequent hysterectomy. CM would be mandatory in some instances, whatever the UF diameter, to avoid further damage or complications. UFs management prior to CS should include a full counselling on pro and cons on the possible consequences of surgical decisioning. To illustrate what was discussed above, authors performed a narrative review with an expert opinion, reporting a case of a 31-year-old woman with a large UF who underwent a CS without myomectomy. Nine hours after CS, puerpera was submitted, for a massive postoperative hemorrhage and hemorrhagic shock, to an emergency relaparotomy with total hysterectomy without salpingo-oophorectomy

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Timing of surgery following SARS-CoV-2 infection: an international prospective cohort study (2021)

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Type of publication:
Journal article

Author(s):
COVIDSurg Collaborative; GlobalSurg Collaborative (COVIDSurg Collaborative includes *Yen Nee Jenny Bo, *Mohammad Iqbal, *Aarti Lakhiani, *Guleed Mohamed, *William Parry-Smith, *Banchhita Sahu of Shrewsbury and Telford Hospital NHS Trust)

Citation:
Anaesthesia, June 2021, Volume 76, Issue 6, Pages 748-758

Abstract:
Peri-operative SARS-CoV-2 infection increases postoperative mortality. The aim of this study was to determine the optimal duration of planned delay before surgery in patients who have had SARS-CoV-2 infection. This international, multicentre, prospective cohort study included patients undergoing elective or emergency surgery during October 2020. Surgical patients with pre-operative SARS-CoV-2 infection were compared with those without previous SARS-CoV-2 infection. The primary outcome measure was 30-day postoperative mortality. Logistic regression models were used to calculate adjusted 30-day mortality rates stratified by time from diagnosis of SARS-CoV-2 infection to surgery. Among 140,231 patients (116 countries), 3127 patients (2.2%) had a pre-operative SARS-CoV-2 diagnosis. Adjusted 30-day mortality in patients without SARS-CoV-2 infection was 1.5% (95%CI 1.4–1.5). In patients with a pre-operative SARS-CoV-2 diagnosis, mortality was increased in patients having surgery within 0–2 weeks, 3–4 weeks and 5–6 weeks of the diagnosis (odds ratio (95%CI) 4.1 (3.3–4.8), 3.9 (2.6–5.1) and 3.6 (2.0–5.2), respectively). Surgery performed ≥ 7 weeks after SARS-CoV-2 diagnosis was associated with a similar mortality risk to baseline (odds ratio (95%CI) 1.5 (0.9–2.1)). After a ≥ 7 week delay in undertaking surgery following SARS-CoV-2 infection, patients with ongoing symptoms had a higher mortality than patients whose symptoms had resolved or who had been asymptomatic (6.0% (95%CI 3.2–8.7) vs. 2.4% (95%CI 1.4–3.4) vs. 1.3% (95%CI 0.6–2.0), respectively). Where possible, surgery should be delayed for at least 7 weeks following SARS-CoV-2 infection. Patients with ongoing symptoms ≥ 7 weeks from diagnosis may benefit from further delay.

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SARS-CoV-2 vaccination modelling for safe surgery to save lives: data from an international prospective cohort study (2021)

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Type of publication:
Journal article

Author(s):
COVIDSurg Collaborative, GlobalSurg Collaborative (COVIDSurg Collaborative includes *Yen Nee Jenny Bo, *Mohammad Iqbal, *Aarti Lakhiani, *Guleed Mohamed, *William Parry-Smith, *Banchhita Sahu of Shrewsbury and Telford Hospital NHS Trust)

Citation:
British Journal of Surgery. 2021 Sep 27;108(9):1056-1063

Abstract:
Background: Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numbers are limited so this study aimed to inform their prioritization by modelling.
Methods: The primary outcome was the number needed to vaccinate (NNV) to prevent one COVID-19-related death in 1 year. NNVs were based on postoperative SARS-CoV-2 rates and mortality in an international cohort study (surgical patients), and community SARS-CoV-2 incidence and case fatality data (general population). NNV estimates were stratified by age (18–49, 50–69, 70 or more years) and type of surgery. Best- and worst-case scenarios were used to describe uncertainty.
Results: NNVs were more favourable in surgical patients than the general population. The most favourable NNVs were in patients aged 70 years or more needing cancer surgery (351; best case 196, worst case 816) or non-cancer surgery (733; best case 407, worst case 1664). Both exceeded the NNV in the general population (1840; best case 1196, worst case 3066). NNVs for surgical patients remained favourable at a range of SARS-CoV-2 incidence rates in sensitivity analysis modelling. Globally, prioritizing preoperative vaccination of patients needing elective surgery ahead of the general population could prevent an additional 58 687 (best case 115 007, worst case 20 177) COVID-19-related deaths in 1 year.
Conclusion: As global roll out of SARS-CoV-2 vaccination proceeds, patients needing elective surgery should be prioritized ahead of the general population.

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Effects of pre-operative isolation on postoperative pulmonary complications after elective surgery: an international prospective cohort study (2022)

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Type of publication:
Journal article

Author(s):
COVIDSurg Collaborative; GlobalSurg Collaborative (COVIDSurg Collaborative includes *Yen Nee Jenny Bo, *Mohammad Iqbal, *Aarti Lakhiani, *Guleed Mohamed, *William Parry-Smith, *Banchhita Sahu of Shrewsbury and Telford Hospital NHS Trust)

Citation:
Anaesthesia. November 2021 Nov, Volume 76, Issue 11, Pages 1454-1464.

Abstract:
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.

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SARS-CoV-2 infection and venous thromboembolism after surgery (2022)

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Type of publication:
Journal article

Author(s):
COVIDSurg Collaborative; GlobalSurg Collaborative. (COVIDSurg Collaborative involves *Yen Nee Jenny Bo, *Mohammad Iqbal, *Aarti Lakhiani, *Guleed Mohamed, *William Parry-Smith, and *Banchhita Sahu of Shrewsbury and Telford Hospitals NHS Trust)

Citation:
Anaesthesia, Jan 2022, Volume77, Issue1, Pages 28-39

Abstract:
SARS-CoV-2 has been associated with an increased rate of venous thromboembolism in critically ill patients. Since surgical patients are already at higher risk of venous thromboembolism than general populations, this study aimed to determine if patients with peri-operative or prior SARS-CoV-2 were at further increased risk of venous thromboembolism. We conducted a planned sub-study and analysis from an international, multicentre, prospective cohort study of elective and emergency patients undergoing surgery during October 2020. Patients from all surgical specialties were included. The primary outcome measure was venous thromboembolism (pulmonary embolism or deep vein thrombosis) within 30 days of surgery. SARS-CoV-2 diagnosis was defined as peri-operative (7 days before to 30 days after surgery); recent (1–6 weeks before surgery); previous (≥7 weeks before surgery); or none. Information on prophylaxis regimens or pre-operative anti-coagulation for baseline comorbidities was not available. Postoperative venous thromboembolism rate was 0.5% (666/123,591) in patients without SARS-CoV-2; 2.2% (50/2317) in patients with peri-operative SARS-CoV-2; 1.6% (15/953) in patients with recent SARS-CoV-2; and 1.0% (11/1148) in patients with previous SARS-CoV-2. After adjustment for confounding factors, patients with peri-operative (adjusted odds ratio 1.5 (95%CI 1.1–2.0)) and recent SARS-CoV-2 (1.9 (95%CI 1.2–3.3)) remained at higher risk of venous thromboembolism, with a borderline finding in previous SARS-CoV-2 (1.7 (95%CI 0.9–3.0)). Overall, venous thromboembolism was independently associated with 30-day mortality (5.4 (95%CI 4.3–6.7)). In patients with SARS-CoV-2, mortality without venous thromboembolism was 7.4% (319/4342) and with venous thromboembolism was 40.8% (31/76). Patients undergoing surgery with peri-operative or recent SARS-CoV-2 appear to be at increased risk of postoperative venous thromboembolism compared with patients with no history of SARS-CoV-2 infection. Optimal venous thromboembolism prophylaxis and treatment are unknown in this cohort of patients, and these data should be interpreted accordingly.

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The effect of the measures taken during the coronavirus pandemic on specialty trainees in obstetrics and gynaecology in the United Kingdom: an online questionnaire survey in one region (2022)

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Type of publication:
Journal article

Author(s):
Elghobashy M; Stout A; Hatti A; *Smotra G; El-Ghobashy A

Citation:
Journal of Obstetrics and Gynaecology. 42(5) (pp 1455-1460), 2022. Date of Publication: 2022.

Abstract:
The coronavirus pandemic (COVID-19) has had unprecedented effects on healthcare delivery. A 34-question online survey was sent to obstetrics and gynaecology trainees within the West Midlands to assess the impact of the pandemic on training, working practices and well-being. 101 responses were received from obstetrics and gynaecology trainees. Trainees reported a significant reduction in both elective and emergency surgeries as well as outpatient clinics. Over one third of respondents felt additional training time may be required following reduction of clinical opportunities. 44% of trainees felt their workload increased significantly. 55% of trainees felt the pandemic had a significant negative impact on their physical and mental well-being. Obstetrics and gynaecology trainees in the West Midlands have adapted to the challenges of the COVID-19 pandemic despite significant impact on their training, working practices and wellbeing. It is important to tailor training to improve trainees' education and combat lost training time during the pandemic. This should be considered for long-term shaping of the obstetrics and gynaecology training pathway. IMPACT STATEMENT What is already known on this subject? Little research is available about the impact of the COVID-19 pandemic on obstetrics and gynaecology trainees. This is the first study of its kind to assess the effect of the pandemic on obstetrics ang gynaecology trainees in the United Kingdom. What do the results of this study add? The results of this study have shown that obstetrics and gynaecology training has been heavily affected during the COVID-19 pandemic. There have been significant impacts on their training, working patterns and physical and mental wellbeing. What are the implications of these findings for clinical practice and/or further research? These findings can be used to mould the obstetrics and gynaecology training pathway based on the feedback given by the trainees during the pandemic. The survey questions can also be utilised as a framework for similar research projects across the United Kingdom Deaneries, among other specialties and around the world.

Appropriately timed COVID-19 PCR testing for hospital inpatients (2021)

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Type of publication:
Conference abstract

Author(s):
*Zaheer Raffeeq, *Nawaid Ahmad, *Emma Crawford, *Devapriya Dev, *Annabel Makan, *Koottalai Srinivasan, *Harmesh Moudgil

Citation:
European Respiratory Journal 2021 58 Suppl 65, PA448

Abstract:
Background: Nosocomial spread of Coronavirus has been an issue for hospitals across the UK, with a recent report by Public Health England (PHE) and the London School of Hygiene and Tropical Medicine (LSHTM) stating that the effective reproduction rate of SARS-CoV-2 in hospitals has been projected to have been as high as 14 during the first wave of the pandemic [1]. In order to stifle this spread hospital Infection and Prevention Control (IPC) set out regular guidelines concerning when patients should be tested for COVID-19.
Aims and objectives: We attempted to assess how well our trust followed the IPC guidance for testing patients for COVID-19, specifically with regard to swab timing following admission to hospital.
Methods: We analysed all admissions to the hospital during the week of 1st October 2020 to the 7th October 2020. We looked at how many patients were appropriately swabbed on day 1, and day 5, as was required according to IPC guidance at the time.
Results: We found that of the 266 patients admitted in the said week, 4 patients (1.5%) had a swab greater than 24 hours after admission, and 17 (6.39%) patients did not have a PCR swab at all. 148 patients stayed in hospital 5 days or greater, with 19 patients (17.27%) receiving their second swab correctly on day 5 of admission and 91 patients (82.73%) either not having their swab on the correct day or not having a follow up swab at all.
Conclusion: While testing on entry was generally done in a timely manner, follow-up swabs are not performed according to the guidelines set out by IPC, and therefore not following evidence-based practice.

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Direct to surgery treatment of suspected lung cancer – results from a UK lung cancer multidisciplinary team (MDT) (2021)

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Type of publication:
Conference abstract

Author(s):
*Manoj Marathe, *Tinaye Mandishona, *Harmesh Moudgil, *Nawaid Ahmad, *Emma Crawford, *Annabel Makan, *Koottalai Srinivasan

Citation:
European Respiratory Journal 2021 58 Suppl 65, OA2640

Abstract:
Introduction: The selective resection of suspicious nodules and masses without pre-operative tissue diagnosis is an established treatment that can shorten time to curative lung cancer treatment. We evaluated the outcomes of this practice in our local MDT.
Methods: We performed a retrospective review of 84 patients with curatively resectable single lung lesions who underwent surgical resection from January 2017 to December 2018 without histological diagnosis.
Results: Malignancy was confirmed in 68/84 (81%) patients. 57/68 patients were diagnosed with a primary lung malignancy and 11/68 with metastatic disease. Figures 1 and 2 show significant and non significant differentiators determined by the chi squared test.
Conclusion: These results support the use of spiculated and / or irregular lesion appearance along with SUV uptake >=2.5 as significant pre-histology differentiators of malignant and benign lesions. Neither past history of cancer nor size of lesion in isolation were predictive of malignancy. Our study gives further evidence that a direct-to-surgery approach is a suitable treatment option for appropriate suspicious nodules.

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Paediatric Injuries Pre And During COVID-19 Requiring an Operative Intervention: The District General Hospital Experience (2021)

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Type of publication:Conference abstract

Author(s):*Howard E.; *Arshad S.; *Kabariti R.; *Roach R.

Citation:British Journal of Surgery; Sep 2021; vol. 108, Supplement 6

Abstract:Aim: To assess the effect of lockdown and the following summer period on paediatric trauma patients who required an operative intervention in a district general hospital. Method(s): A single centre retrospective audit was performed on all paediatric patients <16 years requiring an operative intervention. Two study periods were assessed-pre-COVID (22/03/2019-30/09/2019) and during the COVID-19 pandemic and subsequent summer period (26/03/ 2020-26/09/2020). Data were collected on patient demographics, type of injury sustained, and intervention performed. Result(s): During the COVID-19 pandemic 119 operations were performed, compared to 238 operations performed before the pandemic. Distal radius fractures were the most common injury both during and before the pandemic. However, during the pandemic there was a higher incidence of both hand injuries and lower limb lacerations. The most common type of operation both before and during the pandemic was manipulation under anaesthetic, but there was an increased incidence of washouts performed during the pandemic. Conclusion(s): Despite extensive restructuring of services due to COVID-19, 119 operations were performed during the pandemic. However, this is 119 fewer operations than the same period of the previous year. The reduced rate of operations could be a consequence of increased parental supervision, and less outdoor activity during the pandemic period, but further research is necessary.

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