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Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: The MifeMiso RCT (2021)

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Type of publication:Journal article

Author(s):Devall A.; Chu J.; Gallos I.; Coomarasamy A.; Beeson L.; Cheed V.; Sun Y.; Roberts T.; Ogwulu C.O.; Williams E.; Jones L.; La Fontaine Papadopoulos J.; Hardy P.; Bender-Atik R.; Brewin J.; Hinshaw K.; Ahmed A.; Choudhary M.; 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.; Horne A.; Quenby S.

Citation:Health Technology Assessment; 2021; vol. 25 (no. 68), p. 1-114

Abstract:Background Miscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies end in a miscarriage, and the number of miscarriages in England is estimated to be approximately 125,000 per year. Management of miscarriage can be expectant (i.e. waiting for natural miscarriage), medical (i.e. with drugs) or surgical. About 25% of women opt for medical management; however, there is uncertainty about the optimal drug regimens for medical management. Before National Institute for Health and Care Excellence (NICE) guideline CG154 was published in 2012, it was common practice to use a combination of mifepristone (Mifegyne, Exelgyn, Paris, France) and misoprostol. The 2012 guideline, however, recommended that misoprostol alone should be given to women having medical management. This recommendation was based on very limited evidence, from one study of 115 women, which found no difference between a combination of mifepristone and misoprostol and misoprostol alone. Recognising the limited available evidence, NICE and the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) called for a trial. Objectives The primary objective was to test the hypothesis that treatment with mifepristone plus misoprostol is superior to treatment with misoprostol alone for the resolution of miscarriage within 7 days in women diagnosed by pelvic ultrasound scan with a missed miscarriage in the first 14 weeks of pregnancy. The key secondary objective aimed to test the hypothesis that the addition of mifepristone reduces the need for surgical intervention to resolve the miscarriage. Other secondary objectives aimed to evaluate if the addition of mifepristone reduces the need for further doses of misoprostol, to evaluate if the addition of mifepristone improves other clinical outcomes [including surgical intervention up to and including 7 days post randomisation and after 7 days post randomisation, duration of bleeding, infection, negative pregnancy test at 21 days post randomisation, time from randomisation to discharge from early pregnancy unit (EPU) care, side effects and complications], to evaluate if the addition of mifepristone improves patient satisfaction and acceptability of management and to assess the cost-effectiveness of the combination of mifepristone and misoprostol in the medical management of missed miscarriage. Methods Participants were randomised online in a 1: 1 ratio via a secure internet facility through an Integrated Trial Management System. Minimisation was implemented for maternal age (< 30 or >= 30 years), body mass index (< 35 or >= 35 kg/m2), previous parity (nulliparous or parous women), gestational age (< 70 or >= 70 days), amount of bleeding (Pictorial Blood loss Assessment Chart score; <= 2 or >= 3) and randomising centre. Clinical data were collected up to discharge from EPU care. Participants who agreed to participate in the qualitative study were interviewed by telephone or videoconference or face to face within approximately 6 weeks of their discharge date. The primary analysis was by intention to treat. A withintrial cost-effectiveness study and a nested qualitative study were also conducted as part of the trial. Results A total of 711 women, from 28 hospitals in the UK, received either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 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 (RR) 0.73, 95% confidence interval (CI) 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 (RR 0.70, 95% CI 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, to help bring a timely resolution to the physical process. 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 within-trial cost-effectiveness analysis found that the use of mifepristone and misoprostol resulted in an absolute effect difference of 6.6% (95% CI 0.7% to 12.5%). The average cost per woman was lower in the mifepristone and misoprostol (MifeMiso) group than in the placebo and misoprostol group, with a cost saving of 182 (95% CI 26 to 338). Hence the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. The modelbased analysis, that compared the trial intervention with other existing possible interventions for the management of miscarriage not analysed in the trial, showed that the MifeMiso intervention is dominant when compared with expectant management and the current medical management strategy. However, the intervention is a less effective, although less costly, strategy than surgical management. Conclusions 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.

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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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30-day morbidity and mortality of sleeve gastrectomy, Roux-en-Y gastric bypass and one anastomosis gastric bypass: a propensity score-matched analysis of the GENEVA data (2021)

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Type of publication:Journal article

Author(s):Singhal R.; Wiggins T.; Cardoso V.R.; Gkoutos G.V.; Super J.; Ludwig C.; Mahawar K.; Pedziwiatr M.; Major P.; Zarzycki P.; Pantelis A.; Lapatsanis D.P.; Stravodimos G.; Matthys C.; Focquet M.; Vleeschouwers W.; Spaventa A.G.; Zerrweck C.; Vitiello A.; Berardi G.; Musella M.; Sanchez-Meza A.; Cantu F.J.; Mora F.; Cantu M.A.; Katakwar A.; Reddy D.N.; Elmaleh H.; Hassan M.; Elghandour A.; Elbanna M.; Osman A.; Khan A.; layani L.; Kiran N.; Velikorechin A.; Solovyeva M.; Melali H.; Shahabi S.; Agrawal A.; Shrivastava A.; Sharma A.; Narwaria B.; Narwaria M.; Raziel A.; Sakran N.; Susmallian S.; Karagoz L.; Akbaba M.; Piskin S.Z.; Balta A.Z.; Senol Z.; Manno E.; Iovino M.G.; Qassem M.; Arana-Garza S.; Povoas H.P.; Vilas-Boas M.L.; Naumann D.; Li A.; Ammori B.J.; Balamoun H.; Salman M.; Nasta A.M.; Goel R.; Sanchez-Aguilar H.; Herrera M.F.; Abou-mrad A.; Cloix L.; Mazzini G.S.; Kristem L.; Lazaro A.; Campos J.; Bernardo J.; Gonzalez J.; Trindade C.; Viveiros O.; Ribeiro R.; Goitein D.; Hazzan D.; Segev L.; Beck T.; Reyes H.; Monterrubio J.; Garcia P.; Benois M.; Kassir R.; Contine A.; Elshafei M.; Aktas S.; Weiner S.; Heidsieck T.; Level L.; Pinango S.; Ortega P.M.; Moncada R.; Valenti V.; Vlahovic I.; Boras Z.; Liagre A.; Martini F.; Juglard G.; Motwani M.; Saggu S.S.; Momani H.A.; Lopez L.A.A.; Cortez M.A.C.; Zavala R.A.; D'Haese RN C.; Kempeneers I.; Himpens J.; Lazzati A.; Paolino L.; Bathaei S.; Bedirli A.; Yavuz A.; Buyukkasap C.; Ozaydin S.; Kwiatkowski A.; Bartosiak K.; Waledziak M.; Santonicola A.; Angrisani L.; Iovino P.; Palma R.; Iossa A.; Boru C.E.; De Angelis F.; Silecchia G.; Hussain A.; Balchandra S.; Coltell I.B.; Perez J.L.; Bohra A.; Awan A.K.; Madhok B.; Leeder P.C.; Awad S.; Al-Khyatt W.; Shoma A.; Elghadban H.; Ghareeb S.; Mathews B.; Kurian M.; Larentzakis A.; Vrakopoulou G.Z.; Albanopoulos K.; Bozdag A.; Lale A.; Kirkil C.; Dincer M.; Bashir A.; Haddad A.; Hijleh L.A.; Zilberstein B.; de Marchi D.D.; Souza W.P.; Broden C.M.; Gislason H.; Shah K.; Ambrosi A.; Pavone G.; Tartaglia N.; Kona S.L.K.; Kalyan K.; Perez C.E.G.; Botero M.A.F.; Covic A.; Timofte D.; Maxim M.; Faraj D.; Tseng L.; Liem R.; Oren G.; Dilektasli E.; Yalcin I.; AlMukhtar H.; Hadad M.A.; Mohan R.; Arora N.; Bedi D.; Rives-Lange C.; Chevallier J.-M.; Poghosyan T.; Sebbag H.; Zinai L.; Khaldi S.; Mauchien C.; Mazza D.; Dinescu G.; Rea B.; Perez-Galaz F.; Zavala L.; Besa A.; Curell A.; Balibrea J.M.; Vaz C.; Galindo L.; Silva N.; Caballero J.L.E.; Sebastian S.O.; Marchesini J.C.D.; da Fonseca Pereira R.A.; Sobottka W.H.; Fiolo F.E.; Turchi M.; Coelho A.C.J.; Zacaron A.L.; Barbosa A.; Quinino R.; Menaldi G.; Paleari N.; Martinez-Duartez P.; de Esparza G.M.A.R.; Esteban V.S.; Torres A.; Garcia-Galocha J.L.; Josa M.; Pacheco-Garcia J.M.; Mayo-Ossorio M.A.; Chowbey P.; Soni V.; de Vasconcelos Cunha H.A.; Castilho M.V.; Ferreira R.M.A.; Barreiro T.A.; Charalabopoulos A.; Sdralis E.; Davakis S.; Bomans B.; Dapri G.; Van Belle K.; Takieddine M.; Vaneukem P.; Karaca E.S.A.; Karaca F.C.; Sumer A.; Peksen C.; Savas O.A.; Chousleb E.; Elmokayed F.; Fakhereldin I.; Aboshanab H.M.; Swelium T.; Gudal A.; Gamloo L.; Ugale A.; Ugale S.; Boeker C.; Reetz C.; Hakami I.A.; Mall J.; Alexandrou A.; Baili E.; Bodnar Z.; Maleckas A.; Gudaityte R.; Guldogan C.E.; Gundogdu E.; Ozmen M.M.; Thakkar D.; Dukkipati N.; Shah P.S.; Shah S.S.; Adil M.T.; Jambulingam P.; Mamidanna R.; Whitelaw D.; Jain V.; Veetil D.K.; Wadhawan R.; Torres M.; Tinoco T.; Leclercq W.; Romeijn M.; van de Pas K.; Alkhazraji A.K.; Taha S.A.; Ustun M.; Yigit T.; Inam A.; Burhanulhaq M.; Pazouki A.; Eghbali F.; Kermansaravi M.; Jazi A.H.D.; Mahmoudieh M.; Mogharehabed N.; Tsiotos G.; Stamou K.; Rodriguez F.J.B.; Navarro M.A.R.; Torres O.M.; Martinez S.L.; Tamez E.R.M.; Cornejo G.A.M.; Flores J.E.G.; Mohammed D.A.; Elfawal M.H.; Shabbir A.; Guowei K.; So J.B.; Kaplan E.T.; Kaplan M.; Kaplan T.; Pham D.T.; Rana G.; Kappus M.; Gadani R.; Kahitan M.; Pokharel K.; Osborne A.; Pournaras D.; Hewes J.; Napolitano E.; Chiappetta S.; Bottino V.; Dorado E.; Schoettler A.; Gaertner D.; Fedtke K.; Aguilar-Espinosa F.; Aceves-Lozano S.; Balani A.; Nagliati C.; Pennisi D.; Rizzi A.; Frattini F.; Foschi D.; Benuzzi L.; Parikh C.; Shah H.; Pinotti E.; Montuori M.; Borrelli V.; Dargent J.; Copaescu C.A.; Hutopila I.; Smeu B.; Witteman B.; Hazebroek E.; Deden L.; Heusschen L.; Okkema S.; Aufenacker T.; den Hengst W.; Vening W.; van der Burgh Y.; Ghazal A.; Ibrahim H.; Niazi M.; Alkhaffaf B.; Altarawni M.; Cesana G.C.; Anselmino M.; Uccelli M.; Olmi S.; Stier C.; Akmanlar T.; Sonnenberg T.; Schieferbein U.; Marcolini A.; Awruch D.; Vicentin M.; de Souza Bastos E.L.; Gregorio S.A.; Ahuja A.; Mittal T.; Bolckmans R.; Baratte C.; Wisnewsky J.A.; Genser L.; Chong L.; Taylor L.; Ward S.; Hi M.W.; Heneghan H.; Fearon N.; Geoghegan J.; Ng K.C.; Plamper A.; Rheinwalt K.; Kaseja K.; Kotowski M.; Samarkandy T.A.; Leyva-Alvizo A.; Corzo-Culebro L.; Wang C.; Yang W.; Dong Z.; *Riera M.; *Jain R.; Hamed H.; Said M.; Zarzar K.; Garcia M.; Turkcapar A.G.; Sen O.; Baldini E.; Conti L.; Wietzycoski C.; Lopes E.; Pintar T.; Salobir J.; Aydin C.; Atici S.D.; Ergin A.; Ciyiltepe H.; Bozkurt M.A.; Kizilkaya M.C.; Onalan N.B.D.; Zuber M.N.B.A.; Wong W.J.; Garcia A.; Vidal L.; Beisani M.; Pasquier J.; Vilallonga R.; Sharma S.; Parmar C.; Lee L.; Sufi P.; Sinan H.; Saydam M.

Citation:International Journal of Obesity; 2021 [epub ahead of print]

Abstract:Background: There is a paucity of data comparing 30-day morbidity and mortality of sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one anastomosis gastric bypass (OAGB). This study aimed to compare the 30-day safety of SG, RYGB, and OAGB in propensity score-matched cohorts. Material(s) and Method(s): This analysis utilised data collected from the GENEVA study which was a multicentre observational cohort study of bariatric and metabolic surgery (BMS) in 185 centres across 42 countries between 01/05/2022 and 31/10/2020 during the Coronavirus Disease-2019 (COVID-19) pandemic. 30-day complications were categorised according to the Clavien-Dindo classification. Patients receiving SG, RYGB, or OAGB were propensity-matched according to baseline characteristics and 30-day complications were compared between groups. Result(s): In total, 6770 patients (SG 3983; OAGB 702; RYGB 2085) were included in this analysis. Prior to matching, RYGB was associated with highest 30-day complication rate (SG 5.8%; OAGB 7.5%; RYGB 8.0% (p = 0.006)). On multivariate regression modelling, Insulin-dependent type 2 diabetes mellitus and hypercholesterolaemia were associated with increased 30-day complications. Being a non-smoker was associated with reduced complication rates. When compared to SG as a reference category, RYGB, but not OAGB, was associated with an increased rate of 30-day complications. A total of 702 pairs of SG and OAGB were propensity score-matched. The complication rate in the SG group was 7.3% (n = 51) as compared to 7.5% (n = 53) in the OAGB group (p = 0.68). Similarly, 2085 pairs of SG and RYGB were propensity score-matched. The complication rate in the SG group was 6.1% (n = 127) as compared to 7.9% (n = 166) in the RYGB group (p = 0.09). And, 702 pairs of OAGB and RYGB were matched. The complication rate in both groups was the same at 7.5 % (n = 53; p = 0.07). Conclusion(s): This global study found no significant difference in the 30-day morbidity and mortality of SG, RYGB, and OAGB in propensity score-matched cohorts.

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Machine learning risk prediction of mortality for patients undergoing surgery with perioperative SARS-CoV-2: The COVIDSurg mortality score (2021)

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Type of publication:Journal article

Author(s):COVIDSurg Collaborative (includes Blair, J of Shrewsbury and Telford Hospital NHS Trust)

Citation:British Journal of Surgery; 2021; vol. 19 (no. 4) p.1-19

Abstract:Since the beginning of the COVID-19 pandemic tens of millions of operations have been cancelled as a result of excessive postoperative pulmonary complications (51.2 per cent) and mortality rates (23.8 per cent) in patients with perioperative SARS-CoV-2 infection. There is an urgent need to restart surgery safely in order to minimize the impact of untreated non-communicable disease. As rates of SARS-CoV-2 infection in elective surgery patients range from 1–9 per cent, vaccination is expected to take years to implement globally9 and preoperative screening is likely to lead to increasing numbers of SARS-CoV-2-positive patients, perioperative SARS-CoV-2 infection will remain a challenge for theforeseeable future. In order to inform consent and shared decision making, a robust, globally applicable score is needed to predict individualized mortality risk for patients with perioperative SARS-CoV-2 infection. The authors aimed to develop and validate a machine learning-based risk score to predict postoperative mortality risk in patients with perioperative SARS-CoV-2 infection.

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Effect of COVID-19 pandemic lockdowns on planned cancer surgery for 15 tumour types in 61 countries: an international, prospective, cohort study (2021)

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Type of publication:
Journal article

Author(s):
COVIDSurg Collaborative (includes *Blair J, *Lakhiani A, *Parry-Smith W, *Sahu B of Shrewsbury and Telford Hospital NHS Trust)

Citation:
The Lancet Oncology;  November 2021, Volume 22, Issue 22, Pages 1507-1517

Abstract:
Background: Surgery is the main modality of cure for solid cancers and was prioritised to continue during COVID-19 outbreaks. This study aimed to identify immediate areas for system strengthening by comparing the delivery of elective cancer surgery during the COVID-19 pandemic in periods of lockdown versus light restriction.
Methods; This international, prospective, cohort study enrolled 20 006 adult (≥18 years) patients from 466 hospitals in 61 countries with 15 cancer types, who had a decision for curative surgery during the COVID-19 pandemic and were followed up until the point of surgery or cessation of follow-up (Aug 31, 2020). Average national Oxford COVID-19 Stringency Index scores were calculated to define the government response to COVID-19 for each patient for the period they awaited surgery, and classified into light restrictions (index <20), moderate lockdowns (20–60), and full lockdowns (>60). The primary outcome was the non-operation rate (defined as the proportion of patients who did not undergo planned surgery). Cox proportional-hazards regression models were used to explore the associations between lockdowns and non-operation. Intervals from diagnosis to surgery were compared across COVID-19 government response index groups. This study was registered at ClinicalTrials.gov, NCT04384926.
Findings; Of eligible patients awaiting surgery, 2003 (10·0%) of 20 006 did not receive surgery after a median follow-up of 23 weeks (IQR 16–30), all of whom had a COVID-19-related reason given for non-operation. Light restrictions were associated with a 0·6% non-operation rate (26 of 4521), moderate lockdowns with a 5·5% rate (201 of 3646; adjusted hazard ratio [HR] 0·81, 95% CI 0·77–0·84; p<0·0001), and full lockdowns with a 15·0% rate (1775 of 11 827; HR 0·51, 0·50–0·53; p<0·0001). In sensitivity analyses, including adjustment for SARS-CoV-2 case notification rates, moderate lockdowns (HR 0·84, 95% CI 0·80–0·88; p<0·001), and full lockdowns (0·57, 0·54–0·60; p<0·001), remained independently associated with non-operation. Surgery beyond 12 weeks from diagnosis in patients without neoadjuvant therapy increased during lockdowns (374 [9·1%] of 4521 in light restrictions, 317 [10·4%] of 3646 in moderate lockdowns, 2001 [23·8%] of 11 827 in full lockdowns), although there were no differences in resectability rates observed with longer delays.
Interpretation: Cancer surgery systems worldwide were fragile to lockdowns, with one in seven patients who were in regions with full lockdowns not undergoing planned surgery and experiencing longer preoperative delays. Although short-term oncological outcomes were not compromised in those selected for surgery, delays and non-operations might lead to long-term reductions in survival. During current and future periods of societal restriction, the resilience of elective surgery systems requires strengthening, which might include protected elective surgical pathways and long-term investment in surge capacity for acute care during public health emergencies to protect elective staff and services.

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