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  • 1
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    Impact of the COVID-19 pandemic on surgical care in the Netherlands
    Oxford University Press (OUP) ; 2022
    In:  British Journal of Surgery Vol. 109, No. 12 ( 2022-11-22), p. 1282-1292
    Details
    In: British Journal of Surgery, Oxford University Press (OUP), Vol. 109, No. 12 ( 2022-11-22), p. 1282-1292
    Abstract: The COVID-19 pandemic caused disruption of regular healthcare leading to reduced hospital attendances, repurposing of surgical facilities, and cancellation of cancer screening programmes. This study aimed to determine the impact of COVID-19 on surgical care in the Netherlands. Methods A nationwide study was conducted in collaboration with the Dutch Institute for Clinical Auditing. Eight surgical audits were expanded with items regarding alterations in scheduling and treatment plans. Data on procedures performed in 2020 were compared with those from a historical cohort (2018–2019). Endpoints included total numbers of procedures performed and altered treatment plans. Secondary endpoints included complication, readmission, and mortality rates. Results Some 12 154 procedures were performed in participating hospitals in 2020, representing a decrease of 13.6 per cent compared with 2018–2019. The largest reduction (29.2 per cent) was for non-cancer procedures during the first COVID-19 wave. Surgical treatment was postponed for 9.6 per cent of patients. Alterations in surgical treatment plans were observed in 1.7 per cent. Time from diagnosis to surgery decreased (to 28 days in 2020, from 34 days in 2019 and 36 days in 2018; P & lt; 0.001). For cancer-related procedures, duration of hospital stay decreased (5 versus 6 days; P & lt; 0.001). Audit-specific complications, readmission, and mortality rates were unchanged, but ICU admissions decreased (16.5 versus 16.8 per cent; P & lt; 0.001). Conclusion The reduction in the number of surgical operations was greatest for those without cancer. Where surgery was undertaken, it appeared to be delivered safely, with similar complication and mortality rates, fewer admissions to ICU, and a shorter hospital stay.
    Type of Medium: Online Resource
    ISSN: 0007-1323 , 1365-2168
    URL: Article
    DOI: 10.1093/bjs/znac301
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 2
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    O-003 The SelecTIMO study - clinical outcomes of uninterrupted embryo culture with or without time-lapse based embryo selection versus interrupted standard culture: a randomized controlled trial
    Oxford University Press (OUP) ; 2022
    In:  Human Reproduction Vol. 37, No. Supplement_1 ( 2022-06-29)
    Details
    In: Human Reproduction, Oxford University Press (OUP), Vol. 37, No. Supplement_1 ( 2022-06-29)
    Abstract: Does uninterrupted embryo culture with or without the application of a time-lapse monitoring (TLM) selection algorithm lead to higher (cumulative) ongoing pregnancy rates? Summary answer Uninterrupted embryo culture with or without a TLM selection algorithm and interrupted culture with morphological embryo selection all resulted in comparable (cumulative) ongoing pregnancy rates. What is known already The application of TLM for embryo development has been claimed to improve success rates of IVF and ICSI treatments. Systematic reviews, however, show that evidence supporting the routine clinical use of TLM in IVF laboratories is limited and well-designed RCTs are needed to assess its clinical value. The uninterrupted and stable culture conditions in a TLM incubator may cause an increase of the clinical success rate independent from a possible improvement mediated by TLM based embryo selection procedures. Therefore, three study groups were needed to distinguish these two mechanisms. Study design, size, duration In this multicenter, double-blind, superiority RCT, women were prospectively randomized in three groups between 2017-2020: 1) TLE (Time-Lapse Eeva): embryo selection based on the Eeva® Test (a day three TLM algorithm, used adjunctively with morphology) and uninterrupted culture. 2) TLR (Time-Lapse Routine): routine morphological embryo selection and uninterrupted culture. 3) CON (Control): routine morphological embryo selection and interrupted culture. Embryos were cultured in Geri+ incubators. Randomization was stratified for laboratory-site and ovum pickup number. Participants/materials, setting, methods Women scheduled for day three single embryo transfer (SET) during their first, second or third ovum pickup were included. Primary endpoints were: 1) cumulative ongoing pregnancy rate (cOPR) including fresh SET and associated cryo transfers within 12 months of all women; 2) ongoing pregnancy rate (OPR) after fresh SET in a good-prognosis population: women & lt;41.0 years, ≥5 oocytes, ≥4 fertilized oocytes. Odds ratios (OR) with 95% CI were adjusted for laboratory-site and ovum pickup number. Main results and the role of chance A total of 1731 women were randomly assigned to TLE (577), TLR (579) or CON (575). The 12 month cOPR did not differ significantly between the groups (p = 0.85) with a cOPR of 50.8% (293/577) in TLE, 50.9% (295/579) in TLR and 49.4% (284/575) in CON (TLE vs TLR: OR 0.99, 95% CI 0.79 – 1.25; TLE vs CON: OR 1.06, 95% CI 0.84 – 1.33; CON vs TLR: OR 0.94, 95% CI 0.75 – 1.19). In the good-prognosis population, the OPR after fresh SET was 38.2% (125/327) in TLE, 36.5% (118/323) in TLR and 37.8% (123/325) in CON (p = 0.90). Consistent results were found for pregnancy and live birth rates after fresh embryo transfer and cumulatively within one year. A planned subgroup analysis of three female age groups revealed interaction between age group and treatment on cOPR (p = 0.02). In women of 39 years and older (n = 245), the cOPR was higher in TLE compared to TLR (40.0% vs 23.7%: OR 2.10, 95% CI 1.05-4.21) with no difference between TLE vs CON (40.0% vs 31.5%: OR 1.44, 95% CI 0.76-2.71). Limitations, reasons for caution This study investigated embryo culture in the Geri+ incubator and the Eeva® Test algorithm, which predicts blastocyst formation on day three and was used in combination with morphology for embryo selection, while more TLM systems and algorithms are currently available. Wider implications of the findings Neither embryo selection based on a TLM selection algorithm in combination with morphology (TLE) nor the uninterrupted culture conditions in the Geri+ incubator (TLR) improved (cumulative) ongoing pregnancy and live birth rates after IVF or ICSI. Widespread application for fertility treatments with the promise of improved outcomes should be questioned. Trial registration number NL5314
    Type of Medium: Online Resource
    ISSN: 0268-1161 , 1460-2350
    URL: Article
    DOI: 10.1093/humrep/deac104.003
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 3
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    Clinical outcomes of uninterrupted embryo culture with or without time-lapse-based embryo selection versus interrupted standard culture (SelecTIMO): a three-armed, multicentre, double-blind, randomised controlled trial
    Elsevier BV ; 2023
    In:  The Lancet Vol. 401, No. 10386 ( 2023-04), p. 1438-1446
    Details
    In: The Lancet, Elsevier BV, Vol. 401, No. 10386 ( 2023-04), p. 1438-1446
    Type of Medium: Online Resource
    ISSN: 0140-6736
    URL: Article
    DOI: 10.1016/S0140-6736(23)00168-X
    RVK:
    XA 10000
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
    detail.hit.zdb_id: 3306-6
    SSG: 5,21
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  • 4
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    P-293 Is time-lapse monitoring a safe alternative? Obstetric and neonatal outcomes of a multicenter randomized controlled trial
    Oxford University Press (OUP) ; 2023
    In:  Human Reproduction Vol. 38, No. Supplement_1 ( 2023-06-22)
    Details
    In: Human Reproduction, Oxford University Press (OUP), Vol. 38, No. Supplement_1 ( 2023-06-22)
    Abstract: Are there obstetric or neonatal risks associated with time-lapse monitoring and uninterrupted embryo culture compared to interrupted standard culture and conventional embryo selection? Summary answer The application of time-lapse monitoring using the Geri+ incubator is a safe alternative to standard culture and selection in terms of obstetric and neonatal results. What is known already There is very limited evidence regarding the safety of time-lapse monitoring (TLM) from prospective randomized controlled trials (RCT). Recent RCTs have demonstrated that the application of time-lapse monitoring does not increase (cumulative) live birth rates or the time to pregnancy within one year. However, while most studies only report pregnancy rates, it is essential to also study the safety of this commonly used method. Study design, size, duration The obstetric and neonatal outcomes of patients scheduled for day three single embryo transfer who participated in our multicenter RCT on TLM were studied. Three groups were compared: 1) TLE (Time-Lapse Eeva): embryo selection based on the Eeva® Test (a day three TLM algorithm, used adjunctively with morphology) and uninterrupted culture. 2) TLR (Time-Lapse Routine): routine morphological embryo selection and uninterrupted culture. 3) CON (Control): routine morphological embryo selection and interrupted culture. Participants/materials, setting, methods In total, 1731 IVF/ICSI patients undergoing their first, second or third oocyte pickup were randomized. Obstetric and neonatal data were registered for all pregnancies occurring after fresh and cryo embryo transfers associated with the initial oocyte pickup cycle as well as natural conceptions within one year. Adjusted relative risks with 95% CI were calculated; in view of the three groups and many comparisons only p-values are presented. Main results and the role of chance A total of 838 women had a live birth during the follow-up period (TLE = 281, TLR = 280, CON = 277; p = 0.98). The rate of serious pregnancy complications was not significantly different between the three groups (TLE = 10.7%, TLR = 10.9%, CON = 11.0%; p = 0.99). Mean gestational age at birth was 39.3 (2.0) weeks, 39.4 (1.6) weeks and 39.3 (2.0) weeks, respectively (p = 0.59). The rate of preterm and very preterm birth did not differ significantly between the three groups ( & lt;37 weeks: p = 0.50; & lt;32 weeks: p = 0.20). Average weight at birth was 3396 (598) grams, 3394 (565) grams and 3363 (592) grams, respectively (p = 0.76). Low and very low birthweight also did not differ significantly between the three groups ( & lt;2500g: p = 0.77; & lt;1500 g: p = 0.88). Health problems immediately after delivery were reported for eight babies in the TLE group, twelve in the TLR group and eleven in the CON group (p = 0.66). Major congenital malformations occurred in four children in the TLE group, four in the TLR group and seven in the CON group (p = 0.54). Minor congenital malformations were found in five children in the TLE group, three in the TLR group and five in the CON group (p = 0.73). No significant differences were observed for the mode of delivery and the APGAR scores. Limitations, reasons for caution This study reports the safety of time-lapse monitoring using the Geri+ time-lapse incubator, while more systems are currently available. Wider implications of the findings Uninterrupted embryo culture with or without the use of the Eeva® Test selection algorithm does not lead to increased obstetric or neonatal risks when compared to conventional interrupted embryo culture. Our results suggest that TLM is a safe and effective alternative to standard culture and selection. Trial registration number NTR5423
    Type of Medium: Online Resource
    ISSN: 0268-1161 , 1460-2350
    URL: Article
    DOI: 10.1093/humrep/dead093.651
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 5
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    Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative
    MJS Publishing, Medical Journals Sweden AB ; 2018
    In:  Acta Oncologica Vol. 57, No. 2 ( 2018-02-01), p. 195-202
    Details
    In: Acta Oncologica, MJS Publishing, Medical Journals Sweden AB, Vol. 57, No. 2 ( 2018-02-01), p. 195-202
    Type of Medium: Online Resource
    ISSN: 0284-186X , 1651-226X
    URL: Article
    DOI: 10.1080/0284186X.2017.1346381
    Language: English
    Publisher: MJS Publishing, Medical Journals Sweden AB
    Publication Date: 2018
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    detail.hit.zdb_id: 1492623-4
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  • 6
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    Expectant management versus IUI in unexplained subfertility and a poor pregnancy prognosis (EXIUI study): a randomized controlled trial
    Oxford University Press (OUP) ; 2022
    In:  Human Reproduction Vol. 37, No. 12 ( 2022-11-24), p. 2808-2816
    Details
    In: Human Reproduction, Oxford University Press (OUP), Vol. 37, No. 12 ( 2022-11-24), p. 2808-2816
    Abstract: For couples with unexplained subfertility and a poor prognosis for natural conception, is 6 months expectant management (EM) inferior to IUI with ovarian stimulation (IUI-OS), in terms of live births? SUMMARY ANSWER In couples with unexplained subfertility and a poor prognosis for natural conception, 6 months of EM is inferior compared to IUI-OS in terms of live births. WHAT IS KNOWN ALREADY Couples with unexplained subfertility and a poor prognosis are often treated with IUI-OS. In couples with unexplained subfertility and a relatively good prognosis for natural conception ( & gt;30% in 12 months), IUI-OS does not increase the live birth rate as compared to 6 months of EM. However, in couples with a poor prognosis for natural conception ( & lt;30% in 12 months), the effectiveness of IUI-OS is uncertain. STUDY DESIGN, SIZE, DURATION We performed a non-inferiority multicentre randomized controlled trial within the infrastructure of the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynaecology. We intended to include 1091 couples within 3 years. The couples were allocated in a 1:1 ratio to 6 months EM or 6 months IUI-OS with either clomiphene citrate or gonadotrophins. PARTICIPANTS/MATERIALS, SETTING, METHODS We studied heterosexual couples with unexplained subfertility and a poor prognosis for natural conception ( & lt;30% in 12 months). The primary outcome was ongoing pregnancy leading to a live birth. Non-inferiority would be shown if the lower limit of the one-sided 90% risk difference (RD) CI was less than minus 7% compared to an expected live birth rate of 30% following IUI-OS. We calculated RD, relative risks (RRs) with 90% CI and a corresponding hazard rate for live birth over time based on intention-to-treat and per-protocol (PP) analysis. MAIN RESULTS AND THE ROLE OF CHANCE Between October 2016 and September 2020, we allocated 92 couples to EM and 86 to IUI-OS. The trial was halted pre-maturely owing to slow inclusion. Mean female age was 34 years, median duration of subfertility was 21 months. Couples allocated to EM had a lower live birth rate than couples allocated to IUI-OS (12/92 (13%) in the EM group versus 28/86 (33%) in the IUI-OS group; RR 0.40 90% CI 0.24 to 0.67). This corresponds to an absolute RD of minus 20%; 90% CI: −30% to −9%. The hazard ratio for live birth over time was 0.36 (95% CI 0.18 to 0.70). In the PP analysis, live births rates were 8 of 70 women (11%) in the EM group versus 26 of 73 women (36%) in the IUI-OS group (RR 0.32, 90% CI 0.18 to 0.59; RD −24%, 90% CI −36% to −13%) in line with inferiority of EM. LIMITATIONS, REASONS FOR CAUTION Our trial did not reach the planned sample size, therefore the results are limited by the number of participants. WIDER IMPLICATIONS OF THE FINDINGS This study confirms the results of a previous trial that in couples with unexplained subfertility and a poor prognosis for natural conception, EM is inferior to IUI-OS. STUDY FUNDING/COMPETING INTEREST(S) The trial was supported by a grant of the SEENEZ healthcare initiative. The subsidizing parties were The Dutch Organisation for Health Research and Development (ZonMW 837004023, www.zonmw.nl) and the umbrella organization of 10 health insurers in The Netherlands. E.R.G. receives personal fees from Titus Health care outside the submitted work. M.G. declares unrestricted research and educational grants from Guerbet, Merck and Ferring not related to the presented work, paid to their institution VU medical centre. A.B.H. reports receiving travel and speakers fees from Nordic Pharma and Merck and he is member of the Nordic Pharma ANGEL group and of the Safety Monitoring Board of Womed. C.B.L. reports speakers fee from Inmed and Yingming, and his department receives research grants from Ferring, Merck and Guerbet paid to VU medical centre. B.W.J.M. is supported by a NHMRC Investigator grant (GNT1176437) and reports consultancy for ObsEva and Merck. M.v.W. received a grant from the Netherlands Organisation for Health Research and Development ZonMW (80-8520098-91072). F.M. received two grants from the Netherlands Organisation for Health Research and Development ZonMW (NTR 5599 and NTR 6590). The other authors report no competing interest. TRIAL REGISTRATION NUMBER Dutch Trial register NL5455 (NTR5599) TRIAL REGISTRATION DATE 18 December 2015 DATE OF FIRST PATIENT’S ENROLMENT 26 January 2017
    Type of Medium: Online Resource
    ISSN: 0268-1161 , 1460-2350
    URL: Article
    DOI: 10.1093/humrep/deac236
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 7
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    Risk factors and outcomes of conversion in minimally invasive distal pancreatectomy: a systematic review
    Springer Science and Business Media LLC ; 2021
    In:  Langenbeck's Archives of Surgery Vol. 406, No. 3 ( 2021-05), p. 597-605
    Details
    In: Langenbeck's Archives of Surgery, Springer Science and Business Media LLC, Vol. 406, No. 3 ( 2021-05), p. 597-605
    Abstract: The reported conversion rates for minimally invasive distal pancreatectomy (MIDP) range widely from 2 to 38%. The identification of risk factors for conversion may help surgeons during preoperative planning and patient counseling. Moreover, the impact of conversion on outcomes of MIDP is unknown. Methods A systematic review was conducted as part of the 2019 Miami International Evidence-Based Guidelines on Minimally Invasive Pancreas Resection (IG-MIPR). The PubMed, Cochrane, and Embase databases were searched for studies concerning conversion to open surgery in MIDP. Results Of the 828 studies screened, eight met the eligibility criteria, resulting in a combined dataset including 2592 patients after MIDP. The overall conversion rate was 17.1% (range 13.0–32.7%) with heterogeneity between studies associated with the definition of conversion adopted. Only one study divided conversion into elective and emergency conversion. The main indications for conversion were vascular involvement (23.7%), concern for oncological radicality (21.9%), and bleeding (18.9%). The reported risk factors for conversion included a malignancy as an indication for surgery, the proximity of the tumor to vascular structures in preoperative imaging, higher BMI or visceral fat, and multi-organ resection or extended resection. Contrasting results were seen in terms of blood loss and length of stay in comparing converted MIDP and completed MIDP patients. Conclusion The identified risk factors for conversion from this study can be used for patient selection and counseling. Surgeon experience should be considered when contemplating MIDP for a complex patient. Future studies should divide conversion into elective and emergency conversion.
    Type of Medium: Online Resource
    ISSN: 1435-2443 , 1435-2451
    URL: Article
    DOI: 10.1007/s00423-020-02043-2
    RVK:
    XA 26500
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
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  • 8
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    Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial
    Elsevier BV ; 2019
    In:  The Lancet Gastroenterology & Hepatology Vol. 4, No. 3 ( 2019-03), p. 199-207
    Details
    In: The Lancet Gastroenterology & Hepatology, Elsevier BV, Vol. 4, No. 3 ( 2019-03), p. 199-207
    Type of Medium: Online Resource
    ISSN: 2468-1253
    URL: Article
    DOI: 10.1016/S2468-1253(19)30004-4
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
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  • 9
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    Global overview of the management of acute cholecystitis during the COVID-19 pandemic (CHOLECOVID study)
    Oxford University Press (OUP) ; 2022
    In:  BJS Open Vol. 6, No. 3 ( 2022-05-02)
    Details
    In: BJS Open, Oxford University Press (OUP), Vol. 6, No. 3 ( 2022-05-02)
    Abstract: This study provides a global overview of the management of patients with acute cholecystitis during the initial phase of the COVID-19 pandemic. Methods CHOLECOVID is an international, multicentre, observational comparative study of patients admitted to hospital with acute cholecystitis during the COVID-19 pandemic. Data on management were collected for a 2-month study interval coincident with the WHO declaration of the SARS-CoV-2 pandemic and compared with an equivalent pre-pandemic time interval. Mediation analysis examined the influence of SARS-COV-2 infection on 30-day mortality. Results This study collected data on 9783 patients with acute cholecystitis admitted to 247 hospitals across the world. The pandemic was associated with reduced availability of surgical workforce and operating facilities globally, a significant shift to worse severity of disease, and increased use of conservative management. There was a reduction (both absolute and proportionate) in the number of patients undergoing cholecystectomy from 3095 patients (56.2 per cent) pre-pandemic to 1998 patients (46.2 per cent) during the pandemic but there was no difference in 30-day all-cause mortality after cholecystectomy comparing the pre-pandemic interval with the pandemic (13 patients (0.4 per cent) pre-pandemic to 13 patients (0.6 per cent) pandemic; P = 0.355). In mediation analysis, an admission with acute cholecystitis during the pandemic was associated with a non-significant increased risk of death (OR 1.29, 95 per cent c.i. 0.93 to 1.79, P = 0.121). Conclusion CHOLECOVID provides a unique overview of the treatment of patients with cholecystitis across the globe during the first months of the SARS-CoV-2 pandemic. The study highlights the need for system resilience in retention of elective surgical activity. Cholecystectomy was associated with a low risk of mortality and deferral of treatment results in an increase in avoidable morbidity that represents the non-COVID cost of this pandemic.
    Type of Medium: Online Resource
    ISSN: 2474-9842
    URL: Article
    DOI: 10.1093/bjsopen/zrac052
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 10
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    Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial
    Elsevier BV ; 2015
    In:  The Lancet Vol. 386, No. 10000 ( 2015-09), p. 1269-1277
    Details
    In: The Lancet, Elsevier BV, Vol. 386, No. 10000 ( 2015-09), p. 1269-1277
    Type of Medium: Online Resource
    ISSN: 0140-6736
    URL: Article
    DOI: 10.1016/S0140-6736(15)61168-0
    RVK:
    XA 10000
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2015
    detail.hit.zdb_id: 3306-6
    SSG: 5,21
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