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1. Impact of the COVID-19-pandemic on patients with gynecological malignancies undergoing surgery:A Dutch population-based study using data from the ‘Dutch Gynecological Oncology Audit’

Author

Algera, M. D., van Driel, W. J., Slangen, B. F.M., Kruitwagen, Roy F.P.M., Wouters, M. W.J.M., ten Cate , F.A., Fons, G, Verhoeve, HR, Nagel, H. T.C., Keizer , H.H., van Dijk, J.E.W., Huisman, M, Ebisch, IMW, van de Lande, J., Briet, J., Diepstraten, J, Vollebergh, J.H.A., van der Avoort, Irene A.M., Gaarenstroom, K. N., Overmars, K., Bartelink, L.R., van den Hende, M., Wust, M.D., Scheers, E.C.A.H., Moonen-Delarue, M.W.G., Tjiong, M. Y., Leffers, N., Reesink-Peters, N, Kolk, P., Yigit, Refika, Westenberg, SM, Coppus, S. F.P.J., Schukken, T.K., Van Baal, Wilhelmina M., Minderhoud-Bassie, W., van der Plas-Koning, Y. W.C.M., Algera, M. D., van Driel, W. J., Slangen, B. F.M., Kruitwagen, Roy F.P.M., Wouters, M. W.J.M., ten Cate , F.A., Fons, G, Verhoeve, HR, Nagel, H. T.C., Keizer , H.H., van Dijk, J.E.W., Huisman, M, Ebisch, IMW, van de Lande, J., Briet, J., Diepstraten, J, Vollebergh, J.H.A., van der Avoort, Irene A.M., Gaarenstroom, K. N., Overmars, K., Bartelink, L.R., van den Hende, M., Wust, M.D., Scheers, E.C.A.H., Moonen-Delarue, M.W.G., Tjiong, M. Y., Leffers, N., Reesink-Peters, N, Kolk, P., Yigit, Refika, Westenberg, SM, Coppus, S. F.P.J., Schukken, T.K., Van Baal, Wilhelmina M., Minderhoud-Bassie, W., and van der Plas-Koning, Y. W.C.M.

Abstract

Objective: The COVID-19-pandemic caused drastic healthcare changes worldwide. To date, the impact of these changes on gynecological cancer healthcare is relatively unknown. This study aimed to assess the impact of the COVID-19-pandemic on surgical gynecological-oncology healthcare. Methods: This population-based cohort study included all surgical procedures with curative intent for gynecological malignancies, registered in the Dutch Gynecological Oncology Audit, in 2018–2020. Four periods were identified based on COVID-19 hospital admission rates: ‘Pre-COVID-19’, ‘First wave’, ‘Interim period’, and ‘Second wave’. Surgical volume, perioperative care processes, and postoperative outcomes from 2020 were compared with 2018–2019. Results: A total of 11,488 surgical procedures were analyzed. For cervical cancer, surgical volume decreased by 17.2% in 2020 compared to 2018–2019 (mean 2018–2019: n = 542.5, 2020: n = 449). At nadir (interim period), only 51% of the expected cervical cancer procedures were performed. For ovarian, vulvar, and endometrial cancer, volumes remained stable. Patients with advanced-stage ovarian cancer more frequently received neoadjuvant chemotherapy in 2020 compared to 2018–2019 (67.7% (n = 432) vs. 61.8% (n = 783), p = 0.011). Median time to first treatment was significantly shorter in all four malignancies in 2020. For vulvar and endometrial cancer, the length of hospital stay was significantly shorter in 2020. No significant differences in complicated course and 30-day-mortality were observed. Conclusions: The COVID-19-pandemic impacted surgical gynecological-oncology healthcare: in 2020, surgical volume for cervical cancer dropped considerably, waiting time was significantly shorter for all malignancies, while neoadjuvant chemotherapy administration for advanced-stage ovarian cancer increased. The safety of perioperative healthcare was not negatively impacted by the pandemic, as complications and 30-day-mortality remained stable.

Published
2022

2. Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - The 2Close study

Author

Stegwee, S. I., Jordans, I. P.M., Van Der Voet, L. F., Bongers, M. Y., De Groot, C. J.M., Lambalk, C. B., De Leeuw, R. A., Hehenkamp, W. J.K., Van De Ven, P. M., Bosmans, J. E., Pajkrt, E., Bakkum, E. A., Radder, C. M., Hemelaar, M., Van Baal, W. M., Visser, H., Van Laar, J. O.E.H., Van Vliet, H. A.A.M., Rijnders, R. J.P., Sueters, M., Janssen, C. A.H., Hermes, W., Feitsma, A. H., Kapiteijn, K., Scheepers, H. C.J., Langenveld, J., De Boer, K., Coppus, S. F.P.J., Schippers, D. H., Oei, A. L.M., Kaplan, M., Papatsonis, D. N.M., De Vleeschouwer, L. H.M., Van Beek, E., Bekker, M. N., Huisjes, A. J.M., Meijer, W. J., Deurloo, K. L., Boormans, E. M.A., Van Eijndhoven, H. W.F., Huirne, J. A.F., Health Economics and Health Technology Assessment, APH - Mental Health, and APH - Methodology

Subjects
Quality of life, Fertility, SDG 3 - Good Health and Well-being, Niche, Caesarean section, Long-term outcomes, Closure techniques, Postmenstrual spotting, Reproductive outcomes
Abstract

Background: Double-layer compared to single-layer closure of the uterus after a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness (RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynaecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility. Methods: Women undergoing a first CS regardless of the gestational age will be asked to participate in this multicentre, double blinded randomised controlled trial (RCT). They will be randomised to single-layer closure or double-layer closure of the uterine incision. Single-layer closure (control group) is performed with a continuous running, unlocked suture, with or without endometrial saving technique. Double-layer closure (intervention group) is performed with the first layer in a continuous unlocked suture including the endometrial layer and the second layer is also continuous unlocked and imbricates the first. The primary outcome is the reported number of days with postmenstrual spotting during one menstrual cycle nine months after CS. Secondary outcomes include surgical data, ultrasound evaluation at three months, menstrual pattern, dysmenorrhea, quality of life, and sexual function at nine months. Structured transvaginal ultrasound (TVUS) evaluation is performed to assess the uterine scar and if necessary saline infusion sonohysterography (SIS) or gel instillation sonohysterography (GIS) will be added to the examination. Women and ultrasound examiners will be blinded for allocation. Reproductive outcomes at three years follow-up including fertility, mode of delivery and complications in subsequent deliveries will be studied as well. Analyses will be performed by intention to treat. 2290 women have to be randomised to show a reduction of 15% in the mean number of spotting days. Additionally, a cost-effectiveness analysis will be performed from a societal perspective. Discussion: This RCT will provide insight in the outcomes of single- compared to double-layer closure technique after CS, including postmenstrual spotting and subfertility in relation to niche development measured by ultrasound. Trial registration: Dutch Trial Register (NTR5480). Registered 29 October 2015.

Published
2019
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3. Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - the 2Close study: a multicentre randomised controlled trial

Author

Stegwee, S. I., Jordans, I. P.M., van der Voet, L. F., Bongers, M. Y., de Groot, C. J.M., Lambalk, C. B., de Leeuw, R. A., Hehenkamp, W. J.K., Van De Ven, P. M., Bosmans, J. E., Pajkrt, E., Bakkum, E. A., Radder, C. M., Hemelaar, M., van Baal, W. M., Visser, H., van Laar, J.O.E.H., van Vliet, H. A.A.M., Rijnders, R. J.P., Sueters, M., Janssen, C. A.H., Hermes, W., Feitsma, A. H., Kapiteijn, K., Scheepers, H. C.J., Langenveld, J., de Boer, K., Coppus, S. F.P.J., Schippers, D. H., Oei, A. L.M., Kaplan, M., Papatsonis, D. N.M., de Vleeschouwer, L. H.M., van Beek, E., Bekker, M. N., Huisjes, A. J.M., Meijer, W. J., Deurloo, K. L., Boormans, E. M.A., van Eijndhoven, H. W.F., Huirne, J. A.F., Stegwee, S. I., Jordans, I. P.M., van der Voet, L. F., Bongers, M. Y., de Groot, C. J.M., Lambalk, C. B., de Leeuw, R. A., Hehenkamp, W. J.K., Van De Ven, P. M., Bosmans, J. E., Pajkrt, E., Bakkum, E. A., Radder, C. M., Hemelaar, M., van Baal, W. M., Visser, H., van Laar, J.O.E.H., van Vliet, H. A.A.M., Rijnders, R. J.P., Sueters, M., Janssen, C. A.H., Hermes, W., Feitsma, A. H., Kapiteijn, K., Scheepers, H. C.J., Langenveld, J., de Boer, K., Coppus, S. F.P.J., Schippers, D. H., Oei, A. L.M., Kaplan, M., Papatsonis, D. N.M., de Vleeschouwer, L. H.M., van Beek, E., Bekker, M. N., Huisjes, A. J.M., Meijer, W. J., Deurloo, K. L., Boormans, E. M.A., van Eijndhoven, H. W.F., and Huirne, J. A.F.

Abstract

Background: Double-layer compared to single-layer closure of the uterus after a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness (RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynaecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility. Methods: Women undergoing a first CS regardless of the gestational age will be asked to participate in this multicentre, double blinded randomised controlled trial (RCT). They will be randomised to single-layer closure or double-layer closure of the uterine incision. Single-layer closure (control group) is performed with a continuous running, unlocked suture, with or without endometrial saving technique. Double-layer closure (intervention group) is performed with the first layer in a continuous unlocked suture including the endometrial layer and the second layer is also continuous unlocked and imbricates the first. The primary outcome is the reported number of days with postmenstrual spotting during one menstrual cycle nine months after CS. Secondary outcomes include surgical data, ultrasound evaluation at three months, menstrual pattern, dysmenorrhea, quality of life, and sexual function at nine months. Structured transvaginal ultrasound (TVUS) evaluation is performed to assess the uterine scar and if necessary saline infusion sonohysterography (SIS) or gel instillation sonohysterography (GIS) will be added to the examination. Women and ultrasound examiners will be blinded for allocation. Reproductive outcomes at three years follow-up including fertility, mode of delivery and complications in subsequent deliveries will be studied as well. Analyses will be performed by intention to treat. 2290 women have to be randomised to show a reduction of 15% in the mean number of

Published
2019

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