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Background: Tinzaparin, a low-molecular weight heparin (LMWH), has shown anti-neoplastic properties in animal models and in in vitro studies of human cancer cell lines. The reduction of CA-125 levels during neoadjuvant chemotherapy (NACT) in patients with epithelial ovarian cancer (EOC) co-varies with the prognosis; the larger the decrease in CA-125, the better the prognosis. Purpose: This study aims to evaluate the potential anti-neoplastic effects of tinzaparin by investigating changes in serum CA-125 levels in advanced EOC patients who receive NACT. Material and methods: This is an open randomized multicenter pilot trial. Forty patients with EOC selected to receive NACT will be randomized 1:1 to receive daily addition of tinzaparin or no tinzaparin. The processing and treatment of the patients will otherwise follow the recommendations in the Swedish National Guidelines for Ovarian Cancer. Before every cycle of chemotherapy, preoperatively, and 3 weeks after the last cycle of chemotherapy, a panel of biomarkers, including CA-125, will be measured. Patients: Inclusion criteria are women aged 18 years or older, World Health Organization performance status 0–1, histologically confirmed high-grade serous, endometrioid or clear cell EOC, International Federation of Gynecology and Obstetrics (FIGO) stages III-IV. In addition, a CA-125 level of ≥ 250 kIE/L at diagnosis. Exclusion criteria are contraindications to LMWH, ongoing or recent treatment with unfractionated heparin, LMWH, warfarin or non-vitamin K antagonist oral anticoagulants. Interpretation: This study will make an important contribution to the knowledge of the anti-neoplastic effects of tinzaparin in EOC patients and may thus guide the planning of a future study on the impact of tinzaparin on survival in EOC., Funding Agencies|LEO Pharma AB; Medical Research Council of Southeast Sweden [FORSS-937593, FORSS-980677]; ALF grants Region Ostergotland [RO-963531, RO-966583, RO-936208]; Swedish Society of Gynecologic Oncology

Introduction: Our objective was to investigate the trajectories of anxiety, depression, emotional and social functioning in women with newly diagnosed vulvar cancer from the time of diagnosis to 12 months after treatment. A further aim was to identify risk factors for high levels of anxiety.Material and methods: PROVE (PROspective Vulvar Cancer Evaluation) is a nationwide longitudinal cohort study investigating quality of life in women with newly diagnosed vulvar cancer by the following validated patient-reported outcome measures at diagnosis, and 3 and 12 months after treatment: The Hospital Anxiety and Depression Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Vulvar module VU34. Mean scores, changes over time and associations were analyzed by generalized estimated equations and log-linear regression models, adjusted for possible confounders.Results: Between 2019 and 2021, 105 (69%) women completed the questionnaires at all three time points. At diagnosis, 42% of the women reported elevated anxiety levels, decreasing significantly to 30% during the first 12 months. Insomnia, persisting vulvar symptoms and high information needs were significantly associated with a high level of anxiety (relative risk [RR] 2.1, 95% CI 1.2-3.7 for insomnia; RR 2.8, 95% CI 1.7-4.6 for vulvar symptoms, RR 2.7, 95% CI 1.5-4.9 for information needs). We found a trend towards a higher level of anxiety in younger women (<65 years: RR 1.5, 95% CI 1.0-2.5). Participants reported a low and stable prevalence of depression (14%) and high social functioning throughout the study period.Conclusions: Women with newly diagnosed vulvar cancer report a high level of anxiety at diagnosis. Despite a significant improvement, anxiety remains widely prevalent during the first year of follow-up. Targeting insomnia, vulvar symptoms and unmet needs m, Funding Agencies|We would like to thank Johan Zetterqvist from the Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, for his invaluable statistical support. Furthermore, we thank Perihan Inekci from the Clinical Trials Office at; Department of Learning, Informatics, Management and Ethics, Karolinska Institutet

Background: To investigate if symptoms of depression, anxiety, and stress-coping capacity have an impact on the effect of telephone follow-up (TFU) on trajectories of six recovery measures after hysterectomy and influence the occurrence of unplanned telephone contacts (uTCs) and unplanned visits (uVs) to health care providers.Material and Methods: A post hoc nonrandomized analysis of participants enrolled in a randomized, four-armed, single-blinded, controlled multicenter intervention study comprising 487 women where the women were allocated 1:1:1:1 to one of four TFU models. The Swedish Postoperative Symptom Questionnaire (SPSQ) and two health-related quality of life questionnaires, the EuroQoL-5 dimension with three levels (EQ-5 D-3 L) and the Short-Form-Health Survey (SF-36) assessed the recovery measures. The six recovery measures consisted of the EQ-5D-3L health index, the SF-36 physical component summary (PCS) and mental component summary (MCS), and the maximum and average pain intensity, and symptom sum score obtained from the SPSQ. Psychological distress was evaluated by the psychometric forms, the Hospital Anxiety and Depression Scale and the Stress Coping Inventory. The occurrence of uTC and uV within the 6 weeks of follow-up was registered.Results: Preoperative anxiety, depression, and stress-coping capacity did not modify the effects of the TFU models on the trajectories of the recovery measures, although anxiety and depression were strongly associated with all six recovery measures. uTCs, but not uVs occurred more often in the women with anxiety.Conclusions: Preoperative anxiety, depression, and stress-coping capacity did not appear to influence the effects of TFU contacts on the recovery measures after hysterectomy. Preoperative anxiety seemed to increase the occurrence of uTC. Clinical Trials Registration: ClinicalTrials.gov (NCT01526668)., Funding Agencies|Medical Research Council of Southeast Sweden [FORSS-155141, FORSS-222211, FORSS-308441, FORSS-387761]; Region Ostergotland Council (ALF grants) [RO-200641, RO-276871, RO-356651, RO-448391, RO-540551, RO-607891, RO-699021, RO-794531, RO-931528, RO-936208, RO-968764]; Futurum - the Academy of Health and Care, Region Jonkoping Council [FUTURUM-487481, FUTURUM 579171]; Linkoping University

Epithelial ovarian cancer (EOC) is the gynaecological malignancy with highest mortality. Although adjuvant treatment with carboplatin and paclitaxel leads to an objective response in similar to 80% of these patients, a majority will relapse within two years. Better methods for assessing long-term treatment outcomes are needed. To address this, we established safe and efficacious doses of carboplatin and paclitaxel using IGROV-1 zebrafish-CDX models. Then fluorescently-labelled cell suspensions from 83 tumour biopsies collected at exploratory laparotomy of women with suspected EOC were generated and 37 (45%) were successfully implanted in zebrafish larvae. Among these 19 of 27 pathology-confirmed EOC samples (70%) engrafted. These zebrafish patient-derived tumour xenograft (ZTX) models were treated with carboplatin or paclitaxel and tumour growth/regression and metastatic dissemination were recorded. In a subgroup of nine patients, four ZTX models regressed during carboplatin treatment. All four corresponding patients had > 24 months PFS. Furthermore, both ZTX models established from two patients having < 24 months PFS failed to regress during carboplatin treatment. Seven of eight models seeding < 6 metastatic cells were established from patients having > 24 months PFS. In eleven of fourteen patients, FIGO stage I + II or III tumours gave rise to ZTX models seeding < 4 or > 4 metastatic cells, respectively. In conclusion, ZTX models predicted patients having > 24 or < 24 months PFS, based on response/no response to carboplatin. Furthermore, high metastatic dissemination in ZTX models correlated to shorter PFS and more advanced disease at diagnosis. These preliminary results suggest that ZTX models could become a useful prognostic tool in EOC treatment planning., Funding Agencies|VINNOVA (Swedish Governmental Agency for Innovation Systems) [2017-01444, H2020-MSCA-RISE-Crystal3, LIO-934261]; VINNOVA

Objectives: To determine whether intrathecal morphine (ITM) analgesia in abdominal surgery for presumed gynecological malignancy was associated with better self-reported sleep quality postoperatively compared with epidural analgesia (EDA), and to evaluate risk factors for bad sleep quality. Methods: A secondary analysis of a randomized open controlled trial, comparing ITM and EDA as postoperative analgesia in 80 women undergoing laparotomy under general anaesthesia in an enhanced recovery after surgery framework. A total of 38 women allocated to ITM and 39 to EDA completed the study. The Swedish Postoperative Symptoms Questionnaire assessed symptoms and sleep quality during the first postoperative week. Multiple logistic regression models evaluated risk factors. The results are presented as adjusted odds ratios with 95% CIs. Results: The sleep quality night-by-night did not differ significantly between the women who had ITM or EDA. Risk factors for bad sleep quality for night 1 were age (0.91; 0.84–0.99), operation time (1.02; 1.00–1.03), and opioid consumption (0.96; 0.91–0.99). For night 2, regular use of hypnotics preoperatively (15.81; 1.52–164.27) and opioid consumption (1.07; 1.00–1.14) were independent risk factors for bad sleep. After the second night, no risk factors were disclosed. Conclusions: ITM and EDA did not appear to affect the sleep quality postoperatively differently in women undergoing laparotomy for presumed gynecological malignancy. Risk factors for self-reported bad sleep quality varied during the first 3 days after surgery. Younger age, longer operation time, and preoperative use of hypnotics were associated with bad sleep quality, whereas the effect of opioid consumption on sleep quality varied depending on the time since surgery. These findings merit further studies. © 2023 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada, Cited by: 0Funding: Swedish Society of Medicine [SLS-404711]; Medical Research Council of South-east Sweden [FORSS-8685]; Linkping University; Region OEstergtland [LIO-356191, LIO-441781]

ObjectiveTo evaluate the association between maternal body mass index (BMI) and plasma oxytocin (OT) levels at different OT infusion rates in labor.MethodsA prospective observational study analyzing serial plasma samples in laboring women with OT infusion. The women were categorized into three groups, women with non-obesity (BMI 18.5-29.9, n = 12), obesity (BMI 30.0-34.9, n = 13), and morbid obesity (BMI = 35.0, n = 15). Plasma OT was analyzed using tandem mass spectrometry.ResultsExcept for a low positive correlation between OT levels and BMI and significantly increased plasma OT levels in women with morbid obesity at the OT infusion rate of 3.3 mU/min, no significant differences in OT levels between the BMI groups were found. Further, the inter-individual differences in OT levels were large and no dose-dependent increase of OT levels was seen.ConclusionsOther factors than plasma OT levels may be more likely to determine the clinical response of OT infusion in women with obesity. Perhaps the observed clinical need and individual response would be a better predictor of plasma OT levels than a pre-determined OT infusion rate. The OT dosage guidelines for labor augmentation should be individualized according to clinical response rather than generalized., Funding Agencies|Medical Research Council of Southeast Sweden [RO-939997]; ALF-grants, Region Ostergotland; Swedish Research Council [RO-966229]; Erasmus+ Programme of the European Union [RO-918761]; [2015-4870]; [586571]; [FORSS-909171]; [FORSS-931749]

ObjectiveTo assess detection rates and negative predictive values of sentinel node biopsy in vulvar squamous cell carcinoma with tumors >= 4 cm, multifocal tumors, and in locally recurrent disease.MethodsBetween December 2019 and December 2022, patients with vulvar squamous cell carcinoma with tumors >= 4 cm (group 1), multifocal tumors (group 2), or a first local recurrence without or with previous groin treatment (groups 3 and 4, respectively) were included in a prospective, nationwide multicenter interventional pilot study. The participants underwent a sentinel node biopsy followed by inguinofemoral lymph node dissection. Detection rates, negative predictive values, the proportion of micrometastases, and isolated tumor cells were determined separately for each group.ResultsIn all, 64 women were included, 36 women in group 1 (56%), and 17 women in group 2 (27%). Due to the small number and heterogeneity of the 11 women in groups 3 and 4, they were excluded from further analyses. In groups 1 and 2, 25 women (47%) were diagnosed with node-positive disease, and in 16 women (64%) only in the sentinel nodes. The detection rates varied between 94.1-100% per patient and 84.1-85.3% per groin. No false-negative sentinel nodes were identified, giving a negative predictive value of 100% for group 1 (95% CI 91.2% to 100%) and for group 2 (95% CI 83.9% to 100%). Of the node-positive patients, 32% had micrometastasis or isolated tumor cells only. One third of the metastases were detected by ultrastaging. In 27% of the non-mapping groins, metastases were found in the lymphadenectomy specimen, and in 75% the metastases showed extranodal growth.ConclusionIn this small cohort of patients, we provide further data that may widen the indication of the sentinel node technique to women with tumors >= 4 cm and multifocal tumors.Trial registration numberNCT04147780., Funding Agencies|Swedish Society for Gynecologic Oncology, SSGO

Introduction The primary aim of this study was to determine the incidence of patient-reported pain 1 year after hysterectomy for benign gynecological conditions in relation to occurrence of preoperative pain. The secondary aim was to analyze clinical risk factors for pain 1 year after the hysterectomy in women with and without preoperatively reported pelvic/lower abdominal pain. Material and methods This was a historical cohort study using data from the Swedish National Quality Registry for Gynecological Surgery on 16 694 benign hysterectomies. Data were analyzed using multivariable logistic regression models. Results One year after surgery, 22.4% of women with preoperative pain reported pelvic pain and 7.8% reported de novo pelvic pain. For those with preoperative pain younger age (adjusted odds ratio [aOR] 1.75, 95% confidence interval [CI] 1.38-2.23 and aOR 1.21, 95% CI 1.10-1.34 for women aged <35 and 35-44 years, respectively), not being gainfully employed (aOR 1.43, 95% CI 1.26-1.63), pelvic pain as the main symptom leading to hysterectomy (aOR 1.51, 95% CI 1.19-1.90), endometriosis (aOR 1.18, 95% CI 1.06-1.31), and laparoscopic hysterectomy (aOR 1.30, 95% CI 1.07-1.58), were clinically relevant independent risk factors for pelvic/lower abdominal pain 1 year after surgery, as were postoperative complications within 8 weeks after discharge. Meanwhile, clinically relevant independent risk factors for reporting de novo pain 1 year after surgery were younger age (aOR 2.05, 95% CI 1.08-3.86 and aOR 1.29, 95% CI 1.04-1.60 for women aged <35 and 35-44 years, respectively), and postoperative complications within 8 weeks after discharge. Conclusions The incidence of pelvic pain and de novo pain 1 year after hysterectomy was relatively high. Women with and without reported preoperative pelvic/lower abdominal pain represented clinically different populations. The risk factors for pelvic pain seemed to differ in these two populations. The differences in risk, Funding Agencies|County council of Ostergotland; Linkoping University

Purpose The study aimed to determine if planned telephone follow-up, especially when adding structured, oriented coaching, reduces the intensity of postoperative symptoms and decreases analgesics consumption after benign hysterectomy. Methods A randomized, single-blinded, four-armed, controlled multicenter trial of 525 women scheduled for hysterectomy was conducted in 5 hospitals in the southeast health region of Sweden. The women were allocated 1:1:1:1 into four follow-up models: (A) no telephone follow-up (control group); (B) one planned, structured, telephone follow-up the day after discharge; (C) as B but with additional telephone follow-up once weekly for 6 weeks; and (D) as C but with oriented coaching telephone follow-up on all occasions. Postoperative symptoms were assessed using the Swedish Postoperative Symptoms Questionnaire. Analgesic consumption was registered. Unplanned telephone contacts and visits were registered during the 6 weeks of follow-up. Results In total, 487 women completed the study. Neither pain intensity, nor symptom sum score or analgesic consumption differed between the intervention groups. Altogether, 224 (46.0%) women had unplanned telephone contacts and 203 (41.7%) had unplanned visits. Independent of intervention, the women with unplanned telephone contacts had higher pain intensity and symptom sum scores, particularly if an unplanned telephone contact was followed by a visit, or an unplanned visit was preceded by an unplanned telephone contact. Conclusion Telephone follow-up did not seem to affect recovery regarding symptoms or analgesic consumption after benign hysterectomy in an enhanced recovery after surgery (ERAS) setting. Unplanned telephone contacts and visits were associated with more postoperative symptoms, especially pain. Trial registration The study is registered in ClinicalTrial.gov: NCT01526668 retrospectively from January 27; 2012. Date of enrolment of first patient: October 11; 2011., Funding Agencies|Linkoping University; Medical Research Council of Southeast Sweden [FORSS-155141, FORSS-222211, FORSS308441, FORSS-387761]; ALF Grants Region Ostergotland [RO-276871, RO-356651, RO-448391RO 607891, RO-794531]; Futurum the Academy of Health and Care; Region Jonkoping Council [FUTURUM-487481, FUTURUM 579171]

Objective To assess the impact of lymphadenectomy and lymphoedema of the lower limbs (LLL) on health-related quality of life (HRQoL) 1 year after surgery for endometrial cancer (EC). Design Prospective longitudinal cohort multicentre study. Setting Departments of obstetrics and gynaecology at four university hospitals, six central hospitals and four county hospitals in Sweden. Population Two-hundred-and-thirty-five women with early stage EC were included; 116 with high-risk EC underwent surgery including lymphadenectomy (+LA), and 119 with low-risk EC had surgery without lymphadenectomy (-LA). Methods The generic SF-36 and EQ-5D-3L and the lymphoedema-specific LYMQOL questionnaire were used to assess HRQoL. LLL was assessed by systematic circumferential measurements of the legs enabling volume estimation, clinical evaluation and patient-reported perception of leg swelling. All assessments were carried out on four occasions; preoperatively, and 4-6 weeks, 6 months and 1 year postoperatively. Main outcome measure HRQoL scores. Results No significant differences were seen in HRQoL between the +LA and -LA groups 1 year postoperatively. Irrespective of method of determining LLL, women with LLL were significantly more affected in the LYMQOL domains Function, Appearance/body image and Physical symptoms, but not in the domain Emotion/mood, than women without LLL. No such differences were seen in the generic HRQoL or in the LYMQOL global score between the groups with and without LLL. Conclusions Lymphadenectomy did not seem to affect generic HRQoL adversely. Irrespective of the method of measuring, LLL affected the lymphoedema-specific HRQoL negatively, mainly in physical domains, but had no impact on the generic HRQoL. Tweetable abstract Lymphoedema has impact on lymphoedema-specific, but not on generic, HRQoL, 1 year after surgery for EC., Funding Agencies|Swedish Cancer Society (Cancerfonden)Swedish Cancer Society [CAN2013/620]; Medical Research Council of Southeast SwedenUK Research & Innovation (UKRI)Medical Research Council UK (MRC) [FORSS-308611, FORSS-391311, FORSS-662141, FORSS-858611]; Uppsala-Orebro Regional Research Council [LUL-349271]; Scientific Council of the Region Halland; County Council of Ostergotland; Linkoping University

Purpose: Quantitative sensory testing (QST) can be applied to quantify the sensitivity to different painful stimuli. This study aims to evaluate the association between preoperative pressure and thermal pain thresholds and trajectories of measurements of postoperative recovery (patient-reported daily maximum and average pain intensity, sum score of symptoms, and analgesic consumption) after benign hysterectomy.Patients and Methods: A prospective, longitudinal single-blinded, observational multicenter study was conducted in five hospitals in the southeast of Sweden between 2011 and 2017. A total of 406 women scheduled for abdominal or vaginal hysterectomy for benign conditions were enrolled in the study. QST measuring pressure (PPT), heat (HPT), and cold pain thresholds (CPT) were performed preoperatively. The cut-off levels for dichotomizing the pain thresholds (low/high) were set at the 25-percentile for PPT and HPT and the 75-percentile for CPT. The Swedish Postoperative Symptom Questionnaire was used to measure postoperative pain and other symptoms of discomfort (symptom sum score) on 13 occasions for six weeks postoperatively. Daily analgesic consumption of opioids and non-opioids was registered.Results: A CPT above the 75-percentile was associated with high postoperative maximum pain intensity (p = 0.04), high symptom sum score (p = 0.03) and greater consumption of non-opioids (p = 0.03). A HPT below the 25-percentile was only associated with greater consumption of non-opioids (p = 0.02). PPT was not associated with any of the outcome measures.Conclusion: CPT seemed to be predictive for postoperative pain and symptoms of discomfort after benign hysterectomy. Preoperative QST may be used to individualize the management of postoperative recovery for low pain threshold individuals., Funding Agencies|Medical Research Council of Southeast Sweden [FORSS-228581, FORSS-308471, FORSS-387681, FORSS-482051]; Region OEstergoetland Council (ALF grants) [ROE-200641, ROE-276871, ROE-35651, ROE-448391, ROE-540551, ROE-607891, ROE-699021, ROE-794531, ROE-931528, ROE-936208, ROE-968764]; Linkoeping University; Danish National Research Foundation [DNRF121]

Objective. Optimal management of the contralateral groin in patients with early-stage vulvar squamous cell carcinoma (VSCC) and a metastatic unilateral inguinal sentinel lymph node (SN) is unclear. We analyzed patients who participated in GROINSS-V I or II to determine whether treatment of the contralateral groin can safely be omitted in patients with a unilateral metastatic SN.Methods. We selected the patients with a unilateral metastatic SN from the GROINSS-V I and II databases. We determined the incidence of contralateral additional non-SN metastases in patients with unilateral SN-metastasis who underwent bilateral inguinofemoral lymphadenectomy (IFL). In those who underwent only ipsilateral groin treatment or no further treatment, we determined the incidence of contralateral groin recurrences during follow-up.Results. Of 1912 patients with early-stage VSCC, 366 had a unilateral metastatic SN. Subsequently, 244 had an IFL or no treatment of the contralateral groin. In seven patients (7/244; 2.9% [95% CI: 1.4%-5.8%]) disease was di-agnosed in the contralateral groin: five had contralateral non-SN metastasis at IFL and two developed an isolated contralateral groin recurrence after no further treatment. Five of them had a primary tumor >= 30 mm. Bilateral ra-diotherapy was administered in 122 patients, of whom one (1/122; 0.8% [95% CI: 0.1%-4.5%]) had a contralateral groin recurrence.Conclusion. The risk of contralateral lymph node metastases in patients with early-stage VSCC and a unilateral metastatic SN is low. It appears safe to limit groin treatment to unilateral IFL or inguinofemoral radiotherapy in these cases.(c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/)., On behalf of all GROINSS-V I and II participants: C.F. Levenback, R.H. Hermans, J. Bouda, A. Sharma, D. Luesley, P. Ellis, D.J. Cruickshank, T.J. Duncan, K. Kieser,C. Palle, N.M. Spirtos, D.M. O'Malley, M.M. Leitao, M. Geller, K. Dhar, V. Asher, D.H. Tobias, C. Borgfeldt, J.S. Lea,M. Lood, J. Bailey, B. Eyjolfsdottir, S. Attard-Montalto, K.S. Tewari, P. Persson, R. Manchanda, P. Jensen, L. Van Le

Background Poor survival rates in different cancer types are sometimes blamed on diagnostic and treatment delays, and it has been suggested that such delays might be related to sociodemographic factors such as education and ethnicity. We examined associations of the wait time from diagnosis to surgery and survival in endometrial cancer (EC) and explored patient and tumour factors influencing the wait time. Material and methods In this historical population-based cohort study, The Swedish Quality Registry for Gynaecologic Cancer (SQRGC) was used to identify EC patients who underwent primary surgery between 2010 and 2018. Factors associated with a wait time > 32 d were analysed with logistic regression. The 32-d time point was defined in accordance with the Swedish Standardisation Cancer Care programme. Adjusted Poisson regression analyses were used to analyse excess mortality rate ratio (EMRR). Results Out of 7366 women, 5535 waited > 32 d for surgery and 1098 > 70 d. The overall median wait time was 44 d. The factors most strongly associated with a wait time > 32 d were surgery at a university hospital (adjusted odds ratio [OR] 1.34, 95% confidence interval [CI] 1.08-1.66) followed by country of birth (OR 1.31, 95% CI 1.10-1.55) and year of diagnosis. There were no associations between wait time and histology or age. A wait time < 15 d was associated with higher mortality (adjusted EMRR 2.29,95% CI 1.36-3.84) whereas no negative survival impact was seen with a wait time of 70 d. Age, tumour stage, histology and risk group were highly associated with survival, whereas education, country of origin and hospital level did not have any impact on survival. Conclusions Surgery within the first two weeks after EC diagnosis was associated with worsened survival. A prolonged wait time did not seem to have any significant adverse effect on prognosis., Funding Agencies|Swedish Cancer SocietySwedish Cancer Society; Scientific Council of the Region Halland

Background: Research focusing on patients’ perceptions of the quality of gynecological cancer care is needed. Objective: To adapt the Quality from the Patient’s Perspective instrument for use in gynecological cancer care (QPP-GynCa) and describe patients’ perceptions of their quality of care in terms of the care received and the subjective importance of the aspects of care. Methods: A cross-sectional study 6–8 months after diagnosis was conducted, involving 1511 patients (response rate of 50.4%) included in the Swedish quality registry for gynecologic cancer. Results: The exploratory factor analysis (n = 1431) resulted in the QPP-GynCa with a 5-factor structure and an eigenvalue of ≥1, explaining 73.1% of the total scale variance. The final 27-item version of the QPP-GynCa consisted of 18 items with 8 additional single items and 1 global single item. The Cronbach’s alpha was acceptable for most factors (>.80). Subjective importance scores were higher than corresponding quality of care scores for care received (P ≤ .01)in all dimensions, factors, and items. Conclusions: The QPP-GynCa instrument reflects all 4 dimensions of the theoretical model of quality of care and achieved good validity as a reliable instrument in assessing the quality of gynecological cancer care. Implication for Practice: Information related to self-care, aspects of sexuality, and reducing patient waiting times need improvement. What Is Foundational: This study contributes to a better understanding of quality of gynecological cancer treatment and care. The validated QPP-GynCa instrument will be a platform for more research on how this group of patients experience their received care, as well as importance of each aspect of care.

Introduction Minimally invasive methods to reduce menorrhagia were introduced in the 1980s and 1990s. Transcervical endometrial resection (TCRE) and endometrial ablation (EA) are two of the most frequently used methods. As none of them can guarantee a complete removal of the endometrium, there are concerns that the remaining endometrium may develop to endometrial cancer (EC) later in life. The primary aim was to analyze the long-term incidence of EC after TCRE and EA in a nationwide population. The secondary aim was to assess the two treatment modalities separately. Material and Methods The Swedish National Patient Registry and National Quality Registry for Gynecological Surgery were used for identification of women who had TCRE or EA performed between 1997-2017. The cohort was followed from the first TCRE or EA until hysterectomy, diagnosis of EC, or death. Follow-up data were retrieved from the National Cancer Registry and the National Death Registry. Expected incidence for EC in Swedish women was calculated using Swedish data retrieved from the NORDCAN project after having taken into account differences of age and follow-up time. Cumulative incidence of EC after TCRE and EA, was calculated. A standardized incidence ratio was calculated based on the expected and observed incidence, stratified by age and year of diagnosis. Results In total, 17 296 women (mean age 45.1 years) underwent TCRE (n = 8626) or EA (n = 8670). Excluded were 3121 who had a hysterectomy for benign causes during follow up. During a median follow-up time of 7.1 years (interquartile range 3.1-13.3 years) the numbers of EC were 25 (0.3%) after TCRE and 2 (0.02%) after EA, respectively. The observed incidence was significantly lower than expected (population-based estimate) after EA but not after TCRE, giving a standardized incidence ratio of 0.13 (95% confidence interval [CI] 0.03-0.53) after EA and 1.27 (95% CI 0.86-1.88) after TCRE. Median times to EC were 3.0 and 8.3 years after TCRE and EA, r, Funding Agencies|Swedish Cancer Society

Background: The objective of this trial was to analyze the effect of follow-up programs using standard follow-up protocol and structured coaching on recovery after hysterectomy in an enhanced recovery after surgery setting. Materials and Methods: A randomized, four-armed, single-blinded, controlled multicenter trial comprising 487 women was conducted at five hospitals in the southeast region of Sweden. The women were allocated (1:1:1:1) to Group A: no planned follow-up contact; Group B: a single, planned, structured, broadly kept, follow-up telephone contact with the research nurse the day after discharge; Group C: planned, structured, broadly kept follow-up telephone contact with the research nurse the day after discharge and then once weekly for 6 weeks; and Group D: as Group C, but with planned, structured, coaching telephone contact. Recovery was assessed by the health-related quality of life (HRQoL) questionnaires EuroQoL-5 Dimension with three levels (EQ-5D-3L) and Short-Form-Health Survey with 36 items (SF-36) and duration of sick leave. Results: Neither the recovery of HRQoL as measured by the EQ-5D-3L and the SF-36 nor the duration of sick leave (mean 26.8-28.1 days) differed significantly between the four intervention groups. Irrespective of mode of follow-up contact used, the women had recovered to their baseline EQ-5D-3L health index 4 weeks after surgery. The occurrence of unplanned telephone contact was significantly lower (by nearly 30%) in the women who had structured coaching. Conclusion: Follow-up contact, including coaching, did not seem to expedite the postoperative recovery in HRQoL or reduce the sick leave after hysterectomy, but the coaching seemed to reduce unplanned telephone contact with the health care services. ClinicalTrial.gov (NCT01526668)., Funding Agencies|Medical Research Council of Southeast Sweden [FORSS-155141, FORSS-222211, FORSS-308441, FORSS-387761]; Futurum-the Academy of Health and Care, Region Jonkoping Council [FUTURUM-487481, FUTURUM 579171]; Region Ostergotland Council; Linkoping University

PURPOSE The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (<= 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity., Funding Agencies|Dutch Cancer Society (KWF Kankerbestrijding)KWF Kankerbestrijding; NRG Oncology

Introduction: Deep myometrial invasion (>= 50%) is a prognostic factor for lymph node metastases and decreased survival in endometrial cancer. There is no consensus regarding which pre/intraoperative diagnostic method should be preferred. Our aim was to explore the pattern of diagnostic methods for myometrial invasion assessment in Sweden and to evaluate differences among magnetic resonance imaging (MRI), transvaginal sonography, frozen section, and gross examination in clinical practice. Material and methods: This is a nationwide historical cohort study; women with endometrial cancer with data on assessment of myometrial invasion and FIGO stage I-III registered in the Swedish Quality Registry for Gynecologic Cancer (SQRGC) between 2017 and 2019 were eligible. Data on age, histology, FIGO stage, method, and results of myometrial invasion assessment, pathology results, and hospital level were collected from the SQRGC. The final assessment by the pathologist was considered the reference standard. Results: In the study population of 1401 women, 32% (n = 448) had myometrial invasion of 50% of more. The methods reported for myometrial invasion assessment were transvaginal sonography in 59%, MRI in 28%, gross examination in 8% and frozen section in 5% of cases. Only minor differences were found for age and FIGO stage when comparing methods applied for myometrial invasion assessment. The sensitivity, specificity, and accuracy to find myometrial invasion of 50% or more with transvaginal sonography were 65.6%, 80.3%, and 75.8%, for MRI they were 76.9%, 71.9%, and 73.8%, for gross examination they were 71.9%, 93.6%, and 87.3%, and for frozen section they were 90.0%, 92.7%, and 92.0%, respectively. Conclusions: In Sweden, the assessment of deep myometrial invasion is most often performed with transvaginal sonography, but the sensitivity is lower than for the other diagnostic methods. In clinical practice, the accuracy is moderate for transvaginal sonography and MRI.

Objective To evaluate oxytocin use for augmentation of labour in relation to body mass index (BMI) on admission to the labour ward, focusing on cumulative oxytocin dose and maximum rate of oxytocin infusion during the first stage of labour. Design Prospective observational study. Setting Seven hospitals in Sweden. Participants 1097 nulliparous women with singleton cephalic presentation pregnancy, >= 37 weeks of gestation, spontaneous onset of labour and treatment with oxytocin infusion for labour augmentation. The study population was classified into three BMI subgroups on admission to the labour ward: normal weight (18.5-24.9), overweight (25.0-29.9) and obese (>= 30.0). The cumulative oxytocin dose was measured from the start of oxytocin infusion until the neonate was born. Primary outcome Cumulative oxytocin dose. Secondary outcome Maximum rate of oxytocin infusion during the active phase of first stage of labour. Results The mean cumulative oxytocin dose increased in the BMI groups (normal weight 2278 mU, overweight 3108 mU and obese 4082 mU (p<0.0001)). However, when adjusted for the confounders (cervical dilatation when oxytocin infusion was started, fetal birth weight, epidural analgesia), the significant difference was no longer seen. The maximum oxytocin infusion rate during the first stage of labour differed significantly in the BMI groups when adjusted for the confounding factors individually but not when adjusted for all three factors simultaneously. In addition, the maximum oxytocin infusion rate was significantly higher in women with emergency caesarean section compared with women with vaginal delivery. Conclusions Women with increasing BMI with augmentation of labour received a higher cumulative oxytocin dose and had a higher maximum oxytocin infusion rate during first stage of labour, however, when adjusted for relevant confounders, the difference was no longer seen. In the future, the guidelines for augmentation of labour with o, Funding Agencies|Medical Research Council of Southeast Sweden (FORSS) [FORSS-756621]; County Council of Ostergotland; Linkoping University, Sweden

Knowledge concerning the impact of preoperative planning, patient information and patient factors on the outcome of benign hysterectomy is incomplete. This systematic review summarizes the current knowledge on the effect of preoperative planning and of preoperative patient factors on the outcome of benign hysterectomy. The PubMed/PubMed Central/MEDLINE, Scopus, Web of Science, TRIP Medical Database, Prospero and the Cochrane Library databases were searched. Inclusion criteria were prospective trials, hysterectomy for benign disease, systematic preoperative assessment, and article in English. Eighteen articles were included and categorized according to their main aims: use of a preoperative checklist, preoperative decision-making, preoperative information, and the effect on the outcome of surgery of factors that concerns patients preoperatively. Focused and well directed preoperative assessment and thoroughness in the preoperative decision-making was associated with positive postoperative outcomes. The use of a checklist reduced the overall rate of hysterectomy and increased the use of minimally invasive surgery. Women were often inadequately informed before hysterectomy about the possible side effects after surgery. Preoperative anxiety and preoperative pain were associated with postoperative pain and lower quality of life. The indication for surgery had an impact on the reported quality of life postoperatively. The extent of preoperative planning seemed to affect the outcome of surgery. Preoperative patient factors influenced the postoperative recovery. Prehabilitation measures need further development and should be integrated in the preoperative planning. Prospective studies are warranted to evaluate and improve the preoperative planning in a systematic setting before performing hysterectomy for benign disease., Funding Agencies|Region Ostergotland and Linkoping University

Objectives To compare total costs for hospital stay and post-operative recovery between robotic and abdominal hysterectomy in the treatment of early-stage endometrial cancer provided in an enhanced recovery after surgery (ERAS) setting. Costs were evaluated in relation to health impact, taking a societal perspective. Methods Cost analysis was based on data from an open randomized controlled trial in an ERAS setting at a Swedish tertiary referral university hospital: 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included; 25 women were allocated to robotic and 25 to abdominal hysterectomy. We compared the total time in the operating theater, procedure costs, post-operative care, length of hospital stay, readmissions, informal care, and sick leave as well as the health-related quality of life until 6 weeks after surgery. The comparison was made by using the EuroQoL group form with five dimensions and three levels (EQ-5D). The primary outcome measure was total cost; secondary outcomes were quality-adjusted life-years (QALYs) and cost per QALY. The costs were calculated in Swedish Krona (SEK). Results Age (median (IQR) 68 (63-72) vs 67 (59-75) years), duration of hospital stay (ie, time to discharge criteria were met) (median (IQR) 36 (36-36) vs 36 (36-54) hours), and sick leave (median (IQR) 25 (17-30) vs 31 (36-54) days) did not differ between the robotic and abdominal group. Time of surgery was significantly longer in the robotic group than in the abdominal group (median (IQR) 70 (60-90) vs 56 (49-84) min; p<0.05). The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery. Total costs were 20% higher for the robotic procedure (SEK71 634 vs SEK59 319). The total cost per QALY gained for women in the robotic group was slightly under SEK700 000. Conclusions Robotic hysterectomy used in an ERAS setting in the treatment of early, Funding Agencies|Medical Research Council of South East Sweden; Linkoping University; Region Ostergotland

The aim of this study was to analyse the dynamics of tissue damage and inflammatory response markers perioperatively and whether these differ between women operated with robotic and abdominal hysterectomy in treating early-stage endometrial cancer. At a Swedish university hospital fifty women with early-stage low-risk endometrial cancer were allocated to robotic or abdominal hysterectomy in a randomiszed controlled trial. Blood samples reflecting inflammatory responses (high sensitivity CRP, white blood cells (WBC), thrombocytes, IL-6, cortisol) and tissue damage (creatine kinase (CK), high-mobility group box 1 protein (HMGB1)) were collected one week preoperatively, just before surgery, postoperatively at two, 24 and 48hours, and one and six weeks postoperatively. High sensitivity CRP (p=0.03), WBC (p<0.01), IL-6 (p=0.03) and CK (p=0.03) were significantly lower in the robotic group, but fast transitory. Cortisol returned to baseline two hours after robotic hysterectomy but remained elevated in the abdominal group comparable to the preoperative high levels for both groups just before surgery (p<0.0001). Thrombocytes and HMGB1 were not affected by the mode of surgery. Postoperative inflammatory response and tissue damage were lower after robotic hysterectomy compared to abdominal hysterectomy. A significant remaining cortisol elevation two hours after surgery may reflect a higher stress response in the abdominal group., Funding Agencies|Medical Research Council of South East Sweden [FORSS-222421]; Linkoping University; County Council of Ostergotland [LIO200641, 276871, 356651, 448391]

Background: The aim of this study was to validate a translated Swedish version of the lymphoedema-specific quality of life questionnaire (LYMQOL) in a cohort of Swedish cancer patients with secondary lymphoedema of the limbs after cancer treatment. Material and methods: We recruited 102 patients with lymphoedema of the arms or legs after cancer treatment who were visiting lymphoedema therapists at the departments of oncology at the university hospitals in Linköping and Umeå. The LYMQOL questionnaires were translated forward and backward from English to Swedish. Content and face validity were evaluated. The construct validity was assessed by comparing the LYMQOL with the Short Form Health Survey (SF-36) and the perceived degree of lymphoedema of the limbs, respectively. Reliability was determined through test-retest. The internal consistency was assessed by determining Cronbach’s alpha and by factor analysis. Results: The content and face validity assessments showed that LYMQOL was an easy, clear and not too long questionnaire to use for patients with lymphoedema. Construct validity was high in both versions when compared with the SF-36. The association between the degrees of perceived lymphoedema and the LYMQOL was only significant in the domains Function and Body Image in the arm version, whereas all domains in the leg version were significant. The reliability was good for the arm version (intra-class-correlation coefficients 0.53–0.87) and very good for the leg version (intra-class-correlation coefficients 0.78–0.90). The internal consistency was acceptable to excellent, with Cronbach’s alpha values between 0.79–0.93 (arm-version) and 0.87–0.94 (leg-version). The factor analysis confirmed the usefulness of the four domains in the LYMQOL versions. Conclusions: This study confirmed the validity of the Swedish version of LYMQOL and demonstrated that LYMQOL may be a simple and useful tool for use in clinical practice and scientific conte, Funding Agencies|Swedish Cancer SocietySwedish Cancer Society [CAN 2013/620]; Linkoping University; County Council of Ostergotland