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1. Survival associated with extent of radical hysterectomy in early-stage cervical cancer: a subanalysis of the Surveillance in Cervical CANcer (SCCAN) collaborative study

Author

Bizzarri, N, Querleu, D, Dostalek, L, van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Salehi, S, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Pareja, R, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Falconer, H, Cibula, D, Bizzarri N., Querleu D., Dostalek L., van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Salehi S., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Pareja R., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Falconer H., Cibula D., Bizzarri, N, Querleu, D, Dostalek, L, van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Salehi, S, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Pareja, R, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Falconer, H, Cibula, D, Bizzarri N., Querleu D., Dostalek L., van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Salehi S., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Pareja R., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Falconer H., and Cibula D.

Abstract

Background: International guidelines recommend tailoring the radicality of hysterectomy according to the known preoperative tumor characteristics in patients with early-stage cervical cancer. Objective: This study aimed to assess whether increased radicality had an effect on 5-year disease-free survival in patients with early-stage cervical cancer undergoing radical hysterectomy. The secondary aims were 5-year overall survival and pattern of recurrence. Study Design: This was an international, multicenter, retrospective study from the Surveillance in Cervical CANcer (SCCAN) collaborative cohort. Patients with the International Federation of Gynecology and Obstetrics 2009 stage IB1 and IIA1 who underwent open type B/C1/C2 radical hysterectomy according to Querleu-Morrow classification between January 2007 and December 2016, who did not undergo neoadjuvant chemotherapy and who had negative lymph nodes and free surgical margins at final histology, were included. Descriptive statistics and survival analyses were performed. Patients were stratified according to pathologic tumor diameter. Propensity score match analysis was performed to balance baseline characteristics in patients undergoing nerve-sparing and non–nerve-sparing radical hysterectomy. Results: A total of 1257 patients were included. Of note, 883 patients (70.2%) underwent nerve-sparing radical hysterectomy, and 374 patients (29.8%) underwent non–nerve-sparing radical hysterectomy. Baseline differences between the study groups were found for tumor stage and diameter (higher use of non–nerve-sparing radical hysterectomy for tumors >2 cm or with vaginal involvement; P<.0001). The use of adjuvant therapy in patients undergoing nerve-sparing and non–nerve-sparing radical hysterectomy was 27.3% vs 28.6%, respectively (P=.63). Five-year disease-free survival in patients undergoing nerve-sparing vs non–nerve-sparing radical hysterectomy was 90.1% (95% confidence interval, 87.9–92.2) vs 93.8% (95% confidence in

Published
2023

2. Stratification of lymph node metastases as macrometastases, micrometastases, or isolated tumor cells has no clinical implication in patients with cervical cancer: Subgroup analysis of the SCCAN project

Author

Dostalek, L, Benesova, K, Klat, J, Kim, S, Falconer, H, Kostun, J, dos Reis, R, Zapardiel, I, Landoni, F, Ortiz, D, van Lonkhuijzen, L, Lopez, A, Odetto, D, Borcinova, M, Jarkovsky, J, Salehi, S, Nemejcova, K, Bajsova, S, Park, K, Javurkova, V, Abu-Rustum, N, Dundr, P, Cibula, D, Dostalek L., Benesova K., Klat J., Kim S. H., Falconer H., Kostun J., dos Reis R., Zapardiel I., Landoni F., Ortiz D. I., van Lonkhuijzen L. R. C. W., Lopez A., Odetto D., Borcinova M., Jarkovsky J., Salehi S., Nemejcova K., Bajsova S., Park K. J., Javurkova V., Abu-Rustum N. R., Dundr P., Cibula D., Dostalek, L, Benesova, K, Klat, J, Kim, S, Falconer, H, Kostun, J, dos Reis, R, Zapardiel, I, Landoni, F, Ortiz, D, van Lonkhuijzen, L, Lopez, A, Odetto, D, Borcinova, M, Jarkovsky, J, Salehi, S, Nemejcova, K, Bajsova, S, Park, K, Javurkova, V, Abu-Rustum, N, Dundr, P, Cibula, D, Dostalek L., Benesova K., Klat J., Kim S. H., Falconer H., Kostun J., dos Reis R., Zapardiel I., Landoni F., Ortiz D. I., van Lonkhuijzen L. R. C. W., Lopez A., Odetto D., Borcinova M., Jarkovsky J., Salehi S., Nemejcova K., Bajsova S., Park K. J., Javurkova V., Abu-Rustum N. R., Dundr P., and Cibula D.

Abstract

Background: In cervical cancer, presence of lymph-node macrometastases (MAC) is a major prognostic factor and an indication for adjuvant treatment. However, since clinical impact of micrometastases (MIC) and isolated tumor-cells (ITC) remains controversial, we sought to identify a cut-off value for the metastasis size not associated with negative prognosis. Methods: We analyzed data from 967 cervical cancer patients (T1a1L1-T2b) registered in the SCCAN (Surveillance in Cervical CANcer) database, who underwent primary surgical treatment, including sentinel lymph-node (SLN) biopsy with pathological ultrastaging. The size of SLN metastasis was considered a continuous variable and multiple testing was performed for cut-off values of 0.01-1.0 mm. Disease-free survival (DFS) was compared between N0 and subgroups of N1 patients defined by cut-off ranges. Results: LN metastases were found in 172 (18%) patients, classified as MAC, MIC, and ITC in 79, 54, and 39 patients, respectively. DFS was shorter in patients with MAC (HR 2.20, P = 0.003) and MIC (HR 2.87, P < 0.001), while not differing between MAC/MIC (P = 0.484). DFS in the ITC subgroup was neither different from N0 (P = 0.127) nor from MIC/MAC subgroups (P = 0.449). Cut-off analysis revealed significantly shorter DFS compared to N0 in all subgroups with metastases ≥0.4 mm (HR 2.311, P = 0.04). The significance of metastases <0.4 mm could not be assessed due to limited statistical power (<80%). We did not identify any cut-off for the size of metastasis with significantly better prognosis than the rest of N1 group. Conclusions: In cervical cancer patients, the presence of LN metastases ≥0.4 mm was associated with a significant negative impact on DFS and no cut-off value for the size of metastasis with better prognosis than N1 was found. Traditional metastasis stratification based on size has no clinical implication.

Published
2023

3. Association of Hospital Surgical Volume With Survival in Early-Stage Cervical Cancer Treated With Radical Hysterectomy

Author

Bizzarri, N, Dostalek, L, Van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Falconer, H, Querleu, D, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Salehi, S, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Cibula, D, Bizzarri N., Dostalek L., Van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Falconer H., Querleu D., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Rodriguez J., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Salehi S., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Cibula D., Bizzarri, N, Dostalek, L, Van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Falconer, H, Querleu, D, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Salehi, S, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Cibula, D, Bizzarri N., Dostalek L., Van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Falconer H., Querleu D., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Rodriguez J., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Salehi S., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., and Cibula D.

Abstract

OBJECTIVE: To evaluate the association of number of radical hysterectomies performed per year in each center with disease-free survival and overall survival. METHODS: We conducted an international, multicenter, retrospective study of patients previously included in the Surveillance in Cervical Cancer collaborative studies. Individuals with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB1-IIA1 cervical cancer who underwent radical hysterectomy and had negative lymph nodes at final histology were included. Patients were treated at referral centers for gynecologic oncology according to updated national and international guidelines. Optimal cutoffs for surgical volume were identified using an unadjusted Cox proportional hazard model, with disease-free survival as the outcome and defined as the value that minimizes the P-value of the split in groups in terms of disease-free survival. Propensity score matching was used to create statistically similar cohorts at baseline. RESULTS: A total of 2,157 patients were initially included. The two most significant cutoffs for surgical volume were identified at seven and 17 surgical procedures, dividing the entire cohort into low-volume, middle-volume, and high-volume centers. After propensity score matching, 1,238 patients were analyzed - 619 (50.0%) in the high-volume group, 523 (42.2%) in the middle-volume group, and 96 (7.8%) in the low-volume group. Patients who underwent surgery in higher-volume institutions had progressively better 5-year disease-free survival than those who underwent surgery in lower-volume centers (92.3% vs 88.9% vs 83.8%, P=.029). No difference was noted in 5-year overall survival (95.9% vs 97.2% vs 95.2%, P=.70). Cox multivariable regression analysis showed that FIGO stage greater than IB1, presence of lymphovascular space invasion, grade greater than 1, tumor diameter greater than 20 mm, minimally invasive surgical approach, nonsquamous cell carcinoma histology, and lower-volum

Published
2023

4. Experiences, adherence and satisfaction with a combined exercise and dietary intervention for patients with ovarian cancer undergoing chemotherapy: A mixed-methods study

Author

Stelten, S, van Lonkhuijzen, L R C W, Hartman, Y A W, van Driel, W J, Winkels, R M, Kenter, G G, Buffart, L M, Hoedjes, M, Stelten, S, van Lonkhuijzen, L R C W, Hartman, Y A W, van Driel, W J, Winkels, R M, Kenter, G G, Buffart, L M, and Hoedjes, M

Abstract

Objective: This study examined experiences, adherence and satisfaction with a combined exercise and dietary intervention in patients with ovarian cancer and their healthcare professionals (HCPs) as part of the randomized PADOVA trial.Methods: A mixed-methods approach was used in 24 patients with ovarian cancer receiving first-line chemotherapy who were randomly allocated to a combined exercise and dietary intervention or usual care with counseling sessions post-treatment. Qualitative data on intervention experiences, adherence and satisfaction was collected using semi-structured interviews with patients and their HCPs (n = 18 physical therapists; n = 5 dietitians). Quantitative data on adherence and satisfaction was collected to provide context to qualitative data.Results: Exercise relative dose intensity ranged from 36 to 100% (median 72%) and patients attended 33-133% (median 100%) of the prescribed dietary counseling sessions. Patients appreciated guidance on exercise and nutrition and perceived benefits including improved physical fitness, quality of life, peer support and recovery after surgery and/or chemotherapy cycles. Both patients and HCPs were satisfied with the intervention and perceived that participation exceeded prior expectations. Median patient satisfaction score with the intervention was 8.5 out of 10. Suggestions for improving the intervention included further personalization of the number, content and scheduling of the sessions to preferences of patients and HCPs. Patients in the usual care group reported counseling sessions post-chemotherapy to be too little too late.Conclusions: Patients with ovarian cancer adhered well to the intervention. Numerous perceived benefits of the intervention were reported by patients and HCPs. Good adherence and positive experiences support successful implementation in clinical practice.

Published
2022

5. The annual recurrence risk model for tailored surveillance strategy in patients with cervical cancer

Author

Cibula, D., Dostalek, L., Jarkovsky, J., Mom, C. H., Lopez, A., Falconer, H., Fagotti, Anna, Ayhan, A., Kim, S. H., Isla Ortiz, D., Klat, J., Obermair, A., Landoni, F., Rodriguez, J., Manchanda, R., Kostun, J., dos Reis, R., Meydanli, M. M., Odetto, D., Laky, R., Zapardiel, I., Weinberger, V., Benesova, K., Borcinova, M., Pari, D., Salehi, S., Bizzarri, N., Akilli, H., Abu-Rustum, N. R., Salcedo-Hernandez, R. A., Javurkova, V., Slama, J., van Lonkhuijzen, L. R. C. W., Fagotti A. (ORCID:0000-0001-5579-335X), Cibula, D., Dostalek, L., Jarkovsky, J., Mom, C. H., Lopez, A., Falconer, H., Fagotti, Anna, Ayhan, A., Kim, S. H., Isla Ortiz, D., Klat, J., Obermair, A., Landoni, F., Rodriguez, J., Manchanda, R., Kostun, J., dos Reis, R., Meydanli, M. M., Odetto, D., Laky, R., Zapardiel, I., Weinberger, V., Benesova, K., Borcinova, M., Pari, D., Salehi, S., Bizzarri, N., Akilli, H., Abu-Rustum, N. R., Salcedo-Hernandez, R. A., Javurkova, V., Slama, J., van Lonkhuijzen, L. R. C. W., and Fagotti A. (ORCID:0000-0001-5579-335X)

Abstract

Purpose: Current guidelines for surveillance strategy in cervical cancer are rigid, recommending the same strategy for all survivors. The aim of this study was to develop a robust model allowing for individualised surveillance based on a patient's risk profile. Methods: Data of 4343 early-stage patients with cervical cancer treated between 2007 and 2016 were obtained from the international SCCAN (Surveillance in Cervical Cancer) consortium. The Cox proportional hazards model predicting disease-free survival (DFS) was developed and internally validated. The risk score, derived from regression coefficients of the model, stratified the cohort into significantly distinctive risk groups. On its basis, the annual recurrence risk model (ARRM) was calculated. Results: Five variables were included in the prognostic model: maximal pathologic tumour diameter; tumour histotype; grade; number of positive pelvic lymph nodes; and lymphovascular space invasion. Five risk groups significantly differing in prognosis were identified with a five-year DFS of 97.5%, 94.7%, 85.2% and 63.3% in increasing risk groups, whereas a two-year DFS in the highest risk group equalled 15.4%. Based on the ARRM, the annual recurrence risk in the lowest risk group was below 1% since the beginning of follow-up and declined below 1% at years three, four and >5 in the medium-risk groups. In the whole cohort, 26% of recurrences appeared at the first year of the follow-up, 48% by year two and 78% by year five. Conclusion: The ARRM represents a potent tool for tailoring the surveillance strategy in early-stage patients with cervical cancer based on the patient's risk status and respective annual recurrence risk. It can easily be used in routine clinical settings internationally.

Published
2021

6. The annual recurrence risk model for tailored surveillance strategy in patients with cervical cancer

Author

Cibula, D, Dostalek, L, Jarkovsky, J, Mom, C, Lopez, A, Falconer, H, Fagotti, A, Ayhan, A, Kim, S, Isla Ortiz, D, Klat, J, Obermair, A, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, dos Reis, R, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Benesova, K, Borcinova, M, Pari, D, Salehi, S, Bizzarri, N, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Slama, J, van Lonkhuijzen, L, Cibula D., Dostalek L., Jarkovsky J., Mom C. H., Lopez A., Falconer H., Fagotti A., Ayhan A., Kim S. H., Isla Ortiz D., Klat J., Obermair A., Landoni F., Rodriguez J., Manchanda R., Kostun J., dos Reis R., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Benesova K., Borcinova M., Pari D., Salehi S., Bizzarri N., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Slama J., van Lonkhuijzen L. R. C. W., Cibula, D, Dostalek, L, Jarkovsky, J, Mom, C, Lopez, A, Falconer, H, Fagotti, A, Ayhan, A, Kim, S, Isla Ortiz, D, Klat, J, Obermair, A, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, dos Reis, R, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Benesova, K, Borcinova, M, Pari, D, Salehi, S, Bizzarri, N, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Slama, J, van Lonkhuijzen, L, Cibula D., Dostalek L., Jarkovsky J., Mom C. H., Lopez A., Falconer H., Fagotti A., Ayhan A., Kim S. H., Isla Ortiz D., Klat J., Obermair A., Landoni F., Rodriguez J., Manchanda R., Kostun J., dos Reis R., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Benesova K., Borcinova M., Pari D., Salehi S., Bizzarri N., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Slama J., and van Lonkhuijzen L. R. C. W.

Abstract

Purpose: Current guidelines for surveillance strategy in cervical cancer are rigid, recommending the same strategy for all survivors. The aim of this study was to develop a robust model allowing for individualised surveillance based on a patient's risk profile. Methods: Data of 4343 early-stage patients with cervical cancer treated between 2007 and 2016 were obtained from the international SCCAN (Surveillance in Cervical Cancer) consortium. The Cox proportional hazards model predicting disease-free survival (DFS) was developed and internally validated. The risk score, derived from regression coefficients of the model, stratified the cohort into significantly distinctive risk groups. On its basis, the annual recurrence risk model (ARRM) was calculated. Results: Five variables were included in the prognostic model: maximal pathologic tumour diameter; tumour histotype; grade; number of positive pelvic lymph nodes; and lymphovascular space invasion. Five risk groups significantly differing in prognosis were identified with a five-year DFS of 97.5%, 94.7%, 85.2% and 63.3% in increasing risk groups, whereas a two-year DFS in the highest risk group equalled 15.4%. Based on the ARRM, the annual recurrence risk in the lowest risk group was below 1% since the beginning of follow-up and declined below 1% at years three, four and >5 in the medium-risk groups. In the whole cohort, 26% of recurrences appeared at the first year of the follow-up, 48% by year two and 78% by year five. Conclusion: The ARRM represents a potent tool for tailoring the surveillance strategy in early-stage patients with cervical cancer based on the patient's risk status and respective annual recurrence risk. It can easily be used in routine clinical settings internationally.

Published
2021

8. BETTER QUALITY OF LIFE IN BRCA MUTATION CARRIERS AFTER SALPINGECTOMY WITH DELAYED OOPHORECTOMY COMPARED TO SALPINGO-OOPHORECTOMY; FIRST RESULTS OF THE DUTCH TUBA STUDY

Author

Steenbeek, M. P., Harmsen, M. G., Hoogerbrugge, N., Arts-de Jong, M., Maas, A. H. E. M., Prins, J. B., Bulten, J., Teerenstra, S., Piek, J. M. J., van Doorn, H. C., van Beurden, M., Mourits, M. J. E., Zweemer, R. P., Gaarenstroom, K. N., Slangen, B. F. M., Vos, M. C., van Lonkhuijzen, L. R. C. W., van Mello, N. M., Apperloo, M. J., Coppus, S. F. P. J., Massuger, L. F. A. G., Hermens, R. P. M. G., de Hullu, J. A., Obstetrics and Gynaecology, and CCA - Cancer Treatment and Quality of Life

Published
2019

9. THE CLINICAL POTENTIAL OF FOXL2 C.402C > G MUTATION DETECTION IN CIRCULATING TUMOUR DNA OF PATIENTS WITH GRANULOSA CELL TUMOURS

Author

Groeneweg, J. W., Roze, J. F., Monroe, G. M., Paijens, S. T., Nijman, H. W., van Meurs, H. S., van Lonkhuijzen, L. R. C. W., Piek, J. M. J., Lok, C. A. R., Jonges, G. N., Zweemer, R. P., Obstetrics and Gynaecology, CCA - Cancer Treatment and Quality of Life, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Cardiology, Targeted Gynaecologic Oncology (TARGON), and Translational Immunology Groningen (TRIGR)

Published
2019

10. Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPO2CH): statistical analysis plan of a randomised controlled multicentre superiority trial.

Author

de Jonge, S. W., Wolfhagen, N., Zwinderman, A. H., Hollmann, M. W., Boermeester, M. A., Dijkgraaf, M. G. W., for the EPO2CH study group, Boldingh, Q. J. J., Bom, W. J., Demirkiran, A., van Geffen, O. E., Hendriks, E. R., Hering, J. P., van der Hoeven, J. A. B., Kluyver, E. B., van der Leeuw, B. M. F., van Lonkhuijzen, L. R. C. W., Posthuma, L. M., Sonneveld, D. J. A., and Scheijmans, J. C. G.

Subjects
SURGICAL site infections, ELECTIVE surgery, PERIOPERATIVE care, ABDOMINAL surgery, HEALTH programs, INTRA-abdominal infections
Abstract

Background: Surgical site infections (SSI) are frequent complications after elective abdominal surgery. We designed the Enhanced PeriOperative Care and Health Protection programme (EPO2CH) care bundle, comprising of intraoperative high fractional inspired oxygen; intraoperative goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; glucose control and treatment of hyperglycaemia (> 10 mmol L- 1) in diabetics as well as non-diabetics; and wound irrigation before closure using an aqueous antiseptic. We hypothesise that EPO2CH added to standard care reduces the incidence of SSI compared to standard care alone for elective abdominal surgery.Methods: This trial is designed as an open label, pragmatic randomised controlled parallel-group multicentre superiority trial. The primary endpoint is the incidence of SSI, defined by the Centers for Disease Control and prevention, within 30 days after surgery. The incidence of SSI is assessed using the Dutch national complication register and medical chart review. Secondary endpoints include the SSI incidence within 90 days, incidence of anastomotic leakage at 30 and 90 days, the incidence of incisional hernia within 1 year, mortality within 1 year and 5 years, quality of life, health and disability, and cost-effectiveness. Primarily, an intention-to-treat analysis will be performed to estimate the relative risk using a log binomial model. If not feasible, a logistic regression will be used to estimate the odds ratio. A per-protocol analysis will also be performed. Furthermore, the attributive effect of the distinct interventions will be explored.Discussion: The results of the EPO2CH trial will determine if the EPO2CH bundle is effective to prevent SSI incidence for patients undergoing elective abdominal surgery. Details of the statistical analysis are described in this Statistical Analysis Plan (SAP).Trial Registration: Registration number: Dutch Trial Register Trial NL5572 . Registered on March 3, 2016. SAP version: V1.0, January 8, 2020. This SAP has been written based on study protocol V10. [ABSTRACT FROM AUTHOR]

Published
2021
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11. Implementing safe motherhood: A low-cost intervention to improve the management of eclampsia in a referral hospital in Malawi

Author

Drost, E., van Lonkhuijzen, L. R. C. W., Meguid, T., Lewis, D. Landis, Zeeman, G. G., and Obstetrics and Gynaecology

Subjects
Obstetric emergency, magnesium sulphate, quality of care, safe motherhood, Online training resources, Eclampsia, pregnancy, Millennium Development Goals, female genital diseases and pregnancy complications, reproductive and urinary physiology
Abstract

We evaluated the effect of so-called monitoring and treatment charts on the management of eclampsia in a referral hospital in Malawi. Baseline characteristics, clinical management, as well as overall maternal and perinatal outcome were compared by reviewing the medical files of two groups, before and after introduction of the charts in 2006. The use of the charts has resulted in improved monitoring of women with eclampsia and may have contributed to the reduction in the planned prelabour caesarean section rate from 87% to 33%, as more women underwent induction of labour after stabilisation (P = 0.020). Overall maternal and perinatal outcomes were similar.

Published
2010

13. Body composition and peri- and postoperative complications in patients with gynaecological malignancies: A systematic review.

Author

Heus C, Stelten S, Kenter GG, Buffart LM, and van Lonkhuijzen LRCW

Abstract

Background: In general abdominal surgery, the ratio of fat to muscle mass, or body composition measures, shows a stronger association with complications than body mass index. These studies include male and female patients. Women have a different body composition than men. Therefore, findings from general abdominal surgery cannot be extrapolated to women with cancer. The aim of this systematic review is to summarise the evidence on the association between body composition and peri- and postoperative complications in patients with gynaecological cancer., Methods: Pubmed, Embase and the Cochrane Central databases were searched in June 2023. Studies were eligible if they included patients undergoing surgery for gynaecological cancer and reported on the association between body composition (muscle or fat mass) and surgical complications. The quality of the studies was assessed using the Newcastle-Ottawa quality assessment scale. A best-evidence synthesis was used to summarise the level of evidence., Results: Fifteen studies were included that assessed muscle mass (n = 9) or fat mass (n = 6). We found strong evidence that there was no association between visceral fat and length of hospital stay. We found moderate evidence that a higher amount of good quality muscle was associated with a lower risk of postoperative complications. We found moderate evidence that there was no association between muscle or fat mass (i.e., muscle- or subcutaneous fat) and postoperative complications or fat mass and intraoperative complications. There was insufficient evidence for an association between visceral fat and intraoperative or postoperative complications, and for an association between muscle mass or -quality and length of hospital stay. There was high heterogeneity in the methods used to measure body composition, hampering meta-analyses., Conclusion: The association between body composition, particularly adipose tissue and muscle quality, and complications suggests that these measures may be of interest in determining postoperative risk in women undergoing surgery for gynaecological cancer., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2024
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14. Clinical outcomes of pelvic exenteration for gynecologic malignancies.

Author

Moolenaar LR, van Rangelrooij LE, van Poelgeest MIE, van Beurden M, van Driel WJ, van Lonkhuijzen LRCW, Mom CH, and Zaal A

Subjects
Humans, Female, Retrospective Studies, Margins of Excision, Neoplasm Recurrence, Local pathology, Genital Neoplasms, Female, Pelvic Exenteration adverse effects, Pelvic Exenteration methods, Uterine Cervical Neoplasms pathology
Abstract

Objectives: The aim of this study was to analyze morbidity and survival after pelvic exenteration for gynecologic malignancies and evaluate prognostic factors influencing postoperative outcome., Methods: We retrospectively reviewed all patients who underwent a pelvic exenteration at the departments of gynecologic oncology of three tertiary care centers in the Netherlands, the Leiden University Medical Centre, the Amsterdam University Medical Centre, and the Netherlands Cancer Institute, during a 20-year period. We determined postoperative morbidity, 2- and 5-year overall survival (OS) and 2- and 5-year progression free survival (PFS), and investigated parameters influencing these outcomes., Results: A total of 90 patients were included. The most common primary tumor was cervical cancer (n = 39, 43.3%). We observed at least one complication in 83 patients (92%). Major complications were seen in 55 patients (61%). Irradiated patients had a higher risk of developing a major complication. Sixty-two (68.9%) required ≥1 readmission. Re-operation was required in 40 patients (44.4%). Median OS was 25 months and median PFS was 14 months. The 2-year OS rate was 51.1% and the 2-year PFS rate was 41.5%. Tumor size, resection margins and pelvic sidewall involvement had a negative impact on OS (HR = 2.159, HR = 2.376, and HR = 1.200, respectively). Positive resection margins and pelvic sidewall involvement resulted in decreased PFS (HR = 2.567 and HR = 3.969, respectively)., Conclusion: Postoperative complications after pelvic exenteration for gynecologic malignancies are common, especially in irradiated patients. In this study, a 2-year OS rate of 51.1% was observed. Positive resections margins, tumor size, and pelvic sidewall involvement were related to poor survival outcomes. Adequate selection of patients who will benefit from pelvic exenteration is important., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare and there is no financial interest to report. We certify that the submission is original work and is not under review at any other publication., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2023
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15. Experiences, adherence and satisfaction with a combined exercise and dietary intervention for patients with ovarian cancer undergoing chemotherapy: A mixed-methods study.

Author

Stelten S, van Lonkhuijzen LRCW, Hartman YAW, van Driel WJ, Winkels RM, Kenter GG, Buffart LM, and Hoedjes M

Subjects
Carcinoma, Ovarian Epithelial drug therapy, Female, Humans, Patient Satisfaction, Personal Satisfaction, Ovarian Neoplasms drug therapy, Quality of Life
Abstract

Objective: This study examined experiences, adherence and satisfaction with a combined exercise and dietary intervention in patients with ovarian cancer and their healthcare professionals (HCPs) as part of the randomized PADOVA trial., Methods: A mixed-methods approach was used in 24 patients with ovarian cancer receiving first-line chemotherapy who were randomly allocated to a combined exercise and dietary intervention or usual care with counseling sessions post-treatment. Qualitative data on intervention experiences, adherence and satisfaction was collected using semi-structured interviews with patients and their HCPs (n = 18 physical therapists; n = 5 dietitians). Quantitative data on adherence and satisfaction was collected to provide context to qualitative data., Results: Exercise relative dose intensity ranged from 36 to 100% (median 72%) and patients attended 33-133% (median 100%) of the prescribed dietary counseling sessions. Patients appreciated guidance on exercise and nutrition and perceived benefits including improved physical fitness, quality of life, peer support and recovery after surgery and/or chemotherapy cycles. Both patients and HCPs were satisfied with the intervention and perceived that participation exceeded prior expectations. Median patient satisfaction score with the intervention was 8.5 out of 10. Suggestions for improving the intervention included further personalization of the number, content and scheduling of the sessions to preferences of patients and HCPs. Patients in the usual care group reported counseling sessions post-chemotherapy to be too little too late., Conclusions: Patients with ovarian cancer adhered well to the intervention. Numerous perceived benefits of the intervention were reported by patients and HCPs. Good adherence and positive experiences support successful implementation in clinical practice., Competing Interests: Declaration of Competing Interest The authors have no relevant financial or non-financial interests to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2022
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16. Visceral obesity and muscle mass determined by CT scan and surgical outcome in patients with advanced ovarian cancer. A retrospective cohort study.

Author

Heus C, Smorenburg A, Stoker J, Rutten MJ, Amant FCH, and van Lonkhuijzen LRCW

Subjects
Adult, Aged, Aged, 80 and over, Body Mass Index, Cohort Studies, Cytoreduction Surgical Procedures adverse effects, Cytoreduction Surgical Procedures methods, Female, Humans, Middle Aged, Neoplasm Staging, Ovarian Neoplasms pathology, Postoperative Complications etiology, Predictive Value of Tests, Retrospective Studies, Treatment Outcome, Young Adult, Muscle, Skeletal diagnostic imaging, Obesity, Abdominal diagnostic imaging, Ovarian Neoplasms surgery
Abstract

Objective: Visceral obesity (VO) is a risk factor for developing postoperative complications in patients undergoing abdominal oncological surgery. However, in ovarian cancer patients this influence of body composition on postoperative morbidity is not well established. The aim of this study is to assess the association between body composition and complications in patients with advanced ovarian cancer undergoing cytoreductive surgery., Methods: Patients with FIGO stage 3 or 4 ovarian cancer between 2006 and 2017 were included. Visceral fat area, total skeletal mass and total fat area were measured on a single slice on the level of L3-L4 of the preoperative CT-scan. VO was defined as visceral fat ≥100cm 2 . The perioperative data were extracted retrospectively. A multivariate logistic regression analysis was performed to test the predictive value of multiple variables such as body composition, albumin levels and preoperative morbidity., Results: 298 consecutive patients out of nine referring hospitals were included. VO patients were more likely to be hypertensive (38% vs 17% p < 0.001), and to have an ASA 3 score (21% vs 10% P = 0.012). Complications occurred more often in VO patients (43% vs 21% P < 0.001). Thrombotic events were found in 4.9% of VO patients versus 0.6% of the non-visceral obese patients (p = 0.019). VO(OR: 4.37, p < 0.001), hypertension (OR:1.9, p = 0.046) and duration of surgery (OR: 1.004, p = 0.017) were predictors of post-surgical complications. Muscle mass is not a predictor of complications., Conclusion: Visceral obesity is associated with a higher occurrence of complications in patients with advanced ovarian cancer undergoing cytoreductive surgery., Competing Interests: Declaration of Competing Interest There are no conflicts of interest to disclose of all authors., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2021
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17. Socioeconomic status as an independent risk factor for severe late bowel toxicity after primary radiotherapy for cervical cancer.

Author

Laan JJ, van Lonkhuijzen LRCW, van Os RM, Tytgat KM, Dávila Fajardo R, Pieters BR, Stalpers LJA, and Westerveld GH

Subjects
Adult, Aged, Aged, 80 and over, Analysis of Variance, Female, Follow-Up Studies, Humans, Middle Aged, Retrospective Studies, Risk Factors, Social Class, Young Adult, Radiation Injuries economics, Radiation Injuries etiology, Uterine Cervical Neoplasms economics, Uterine Cervical Neoplasms radiotherapy
Abstract

Objective: To evaluate the frequency of and risk factors for severe late bowel toxicity after curative radiotherapy in women treated for locally advanced cervical cancer., Methods: Included were 515 women treated for locally advanced cervical cancer with primary radiotherapy with curative intent from 1992 to 2013. Bowel toxicity was graded according to the Common Terminology Criteria for Adverse Events. Associations between risk factors and severe late bowel toxicity were assessed using Cox proportional hazards regression models., Results: Median follow-up was 78months. Fifty-nine patients developed severe late bowel toxicity. The actuarial 3-year and 5-year severe late bowel toxicity rates were both 13%. In the multivariable analysis, factors significantly associated with severe late bowel toxicity were: smoking (HR 2.59 [1.48-4.55]), severe acute bowel toxicity (HR 2.46 [1.24-4.49]), previous major abdominal surgery (HR 2.35 [1.20-4.60]), hypertension (HR 2.33 [1.23-4.40]), parametrial boost (HR 2.18 [1.10-4.33]), low socioeconomic status (HR 2.05 [1.17-3.59]) and low BMI (HR 0.93 [0.88-0.99]). First symptoms of severe late bowel toxicity were reported after a median follow-up of 9months, but occurred up to 10years after end of treatment. Only one third of the patients with severe late bowel toxicity were referred to a gastroenterologist., Conclusions: Severe late bowel toxicity is a frequent complication of definitive radiotherapy for cervical cancer. Several independent risk factors were found which warrant further research. A standardized and structured approach in the early diagnostics and management of bowel toxicity is needed., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Published
2017
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18. Implementing safe motherhood: a low-cost intervention to improve the management of eclampsia in a referral hospital in Malawi.

Author

Drost E, van Lonkhuijzen LR, Meguid T, Landis Lewis D, and Zeeman GG

Subjects
Adolescent, Adult, Costs and Cost Analysis, Eclampsia economics, Female, Guideline Adherence, Humans, Malawi, Medical Records, Practice Guidelines as Topic, Pregnancy, Pregnancy Outcome, Professional Practice standards, Referral and Consultation economics, Young Adult, Eclampsia therapy, Hospitalization economics
Abstract

We evaluated the effect of so-called monitoring and treatment charts on the management of eclampsia in a referral hospital in Malawi. Baseline characteristics, clinical management, as well as overall maternal and perinatal outcome were compared by reviewing the medical files of two groups, before and after introduction of the charts in 2006. The use of the charts has resulted in improved monitoring of women with eclampsia and may have contributed to the reduction in the planned prelabour caesarean section rate from 87% to 33%, as more women underwent induction of labour after stabilisation (P = 0.020). Overall maternal and perinatal outcomes were similar., (© 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.)

Published
2010
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