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1.
Acta Obstet Gynecol Scand ; 103(2): 368-377, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38031442

ABSTRACT

INTRODUCTION: The Medtronic Hugo™ Robot-assisted Surgery (RAS) system was recently approved for clinical use. We explored the safety and feasibility of this system for endometriosis surgery. The primary outcome was safe case completion without major surgical complications (Clavien-Dindo grade ≤2) and no conversion to open surgery or laparoscopy. MATERIAL AND METHODS: Surgeries for endometriosis performed at the Department of Gynecology, Rigshospitalet, on the Medtronic Hugo™ RAS system were included. Two experienced robotic surgeons performed all surgeries with their usual robotic team. The variables included were patient demographics, peri- and postoperative data, complications and 30-day readmission rate. We used the IDEAL framework 1/2a for surgical innovation in this descriptive study. RESULTS: The first 12 patients were included. All cases were completed without intraoperative complications or conversion. Four patients experienced Clavien-Dindo grade 1 postoperative complications. No patients were re-admitted within 30 days. Median docking time (17 minutes), console time (87.5 minutes), blood loss (40 mL) and length of hospital stay (1 day) were acceptable compared with previous literature. CONCLUSIONS: In this pilot study, we found the Medtronic Hugo™ RAS system safe and feasible for robot-assisted surgery for endometriosis. The advent of new robotic systems is welcomed to accelerate the development of technology that will advance surgical care for patients across the globe.


Subject(s)
Endometriosis , Laparoscopy , Robotic Surgical Procedures , Robotics , Female , Humans , Endometriosis/surgery , Pilot Projects , Laparoscopy/adverse effects
3.
Front Glob Womens Health ; 4: 1102006, 2023.
Article in English | MEDLINE | ID: mdl-36994241

ABSTRACT

Objectives: This study aims to translate and cross-culturally adapt the standard version of the World Endometriosis Research Foundation (WERF) EPHect Endometriosis Patient Questionnaire (EPQ) into Danish and to ensure equivalence of a Danish electronic version. Methods: The translation, cultural adaption, and electronic migration followed recommendations from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Critical Path Institute. Ten women with endometriosis were enrolled for cognitive debriefing of the paper version (pEPQ) after translation and back translation. The questionnaire was then migrated into an electronic version (eEPQ) and subsequently tested for usability and measurement equivalence by five women with endometriosis. Results: Cross-cultural alterations were needed for medical terms, response options for ethnicity, the educational system, and measurement units. Thirteen questions were altered after back translation, while 21 underwent minor changes after cognitive debriefing. After testing the eEPQ, 13 questions were altered. Questions tested for measurement equivalence across the two modes of administration were found comparable. The median time-to-complete the pEPQ and eEPQ was 62 min (range: 29-110) and 63 min (range: 31-88), respectively. General comments included the questionnaire being relevant but long and repetitive. Conclusions: We find the the Danish pEPQ and eEPQ similar and comparable to the original English instrument. However, attention must be drawn to questions regarding measurement units, ethnicity, and educational systems before cross-country comparison. The Danish pEPQ and eEPQ are suitable for obtaining subjective data on women with endometriosis.

4.
Fertil Steril ; 119(5): 826-835, 2023 05.
Article in English | MEDLINE | ID: mdl-36608920

ABSTRACT

OBJECTIVE: To study whether endometriosis is associated with pregnancy loss and recurrent pregnancy loss (RPL). DESIGN: Nationwide historical cohort study with a nested case-control analysis. SETTING: National health registers. PATIENT(S): A total of 29,563 women born between 1957 and 1997 were identified in the national health registers, diagnosed with endometriosis between 1977 and 2017, and age-matched 1:10 with 295,630 women without endometriosis. The number of pregnancy losses was assessed, and data were analyzed with conditional logistic regression. INTERVENTION(S): Endometriosis (International Classification of Diseases, 8th Revision, 62530-62539, and International Classification of Diseases, 10th Revision, DN80.0-9). MAIN OUTCOME MEASURE(S): The primary outcomes of interest were the numbers of pregnancy losses categorized as 0, 1, 2, and ≥ 3 losses, unadjusted and adjusted for gravidity, and RPL. The secondary outcome measures were the predefined types of pregnancy losses. Pregnancy loss was defined as the spontaneous demise of a pregnancy until 22 weeks of gestation. Primary RPL was defined as 3 or more consecutive pregnancy losses with no prior live birth or stillbirth, and secondary RPL was defined as 1 or more births followed by 3 or more consecutive losses. RESULT(S): A total of 18.9%, 3.9%, and 2.1% of ever-pregnant women with endometriosis had 1, 2, and ≥ 3 pregnancy losses compared with 17.3%, 3.5%, and 1.5% of the women without endometriosis, corresponding to the odds ratios of 1.13 (95% confidence interval, 1.09-1.17), 1.18 (1.10-1.26), and 1.44 (1.31-1.59), respectively. When adjusted also for gravidity, the corresponding results were 1.37 (95% confidence interval, 1.32-1.42), 1.75 (1.62-1.89), and 2.57 (2.31-2.85), respectively. The following predefined subgroups of RPL were positively associated with endometriosis: primary; secondary; secondary after giving birth to a boy; after a complicated delivery; and ≥ 3 pregnancy losses before the age of 30 years. Six endometriosis subgroup analyses found an association between endometriosis and pregnancy loss. These analyses were women diagnosed in the 4 decades between 1977 and 2017, women with adenomyosis, and women with adenomyosis only. CONCLUSION(S): This nationwide cohort study found endometriosis to be associated with pregnancy loss and RPL, and the association strengthened with an increasing number of losses.


Subject(s)
Abortion, Habitual , Abortion, Induced , Adenomyosis , Endometriosis , Male , Pregnancy , Female , Humans , Adult , Cohort Studies , Endometriosis/diagnosis , Endometriosis/epidemiology , Endometriosis/complications , Adenomyosis/complications , Abortion, Habitual/diagnosis
5.
Hum Reprod Open ; 2022(2): hoac015, 2022.
Article in English | MEDLINE | ID: mdl-35441092

ABSTRACT

STUDY QUESTION: What is the microbiome profile across different body sites in relation to the normal menstrual cycle (with and without hormonal contraception), recurrent pregnancy loss (RPL) (before and during pregnancy, pregnancy loss or birth) and endometriosis (before, during and after surgery)? How do these profiles interact with genetics, environmental exposures, immunological and endocrine biomarkers? WHAT IS KNOWN ALREADY: The microbiome is a key factor influencing human health and disease in areas as diverse as immune functioning, gastrointestinal disease and mental and metabolic disorders. There is mounting evidence to suggest that the reproductive microbiome may be influential in general and reproductive health, fertility and pregnancy outcomes. STUDY DESIGN SIZE DURATION: This is a prospective, longitudinal, observational study using a systems biology approach in three cohorts totalling 920 participants. Since microbiome profiles by shot-gun sequencing have never been investigated in healthy controls during varying phases of the menstrual cycle, patients with RPL and patients with endometriosis, no formal sample size calculation can be performed. The study period is from 2017 to 2024 and allows for longitudinal profiling of study participants to enable deeper understanding of the role of the microbiome and of host-microbe interactions in reproductive health. PARTICIPANTS/MATERIALS SETTING METHODS: Participants in each cohort are as follows: Part 1 MiMens-150 healthy women with or without hormonal contraception; Part 2 MiRPL-200 couples with RPL, 50 healthy couples with prior uncomplicated pregnancy and 150 newborns; Part 3 MiEndo-120 patients with endometriosis requiring surgery with or without hormonal treatment. Microbiome profiles from saliva, faeces, rectal mucosa, vaginal fluid and endometrium will be studied, as well as the Omics profile, endocrine disrupting chemicals and endocrine and immune factors in blood, hair, saliva and urine. Pregnancy loss products, seminal microbiome, HLA types, endometriotic tissue and genetic risk and comprehensive questionnaire data will also be studied, where appropriate. Correlations with mental and physical health will be evaluated. STUDY FUNDING/COMPETING INTERESTS: This work is supported by funding from Ferring Pharmaceuticals ([#MiHSN01] to H.S.N., M.C.K., M.E.M., L.E.V., L.E., I.S.-K., F.B., L.W.H., E.F. and M.H.), Rigshospitalet's Research Funds ([#E-22614-01 and #E-22614-02] to M.C.K. and [#E-22222-06] to S.B.), Niels and Desiree Yde's Foundation (S.B., endocrine analyses [#2015-2784]), the Musikforlæggerne Agnes and Knut Mørk's Foundation (S.B., endocrine and immune analyses [#35108-001]) and Oda and Hans Svenningsen's Foundation ([#F-22614-08] to H.S.N.). Medical writing assistance with this manuscript was provided by Caroline Loat, PhD, and funded by Ferring Pharmaceuticals. H.S.N. reports personal fees from Ferring Pharmaceuticals, Merck Denmark A/S, Ibsa Nordic, Astra Zeneca and Cook Medical outside the submitted work. K.W. is a full-time employee of Ferring Pharmaceuticals. No other conflicts are reported. TRIAL REGISTRATION NUMBER: N/A. TRIAL REGISTRATION DATE: N/A. DATE OF FIRST PATIENT'S ENROLMENT: N/A.

6.
BMJ Case Rep ; 14(8)2021 Aug 26.
Article in English | MEDLINE | ID: mdl-34446516

ABSTRACT

We outline a case of vaginal endometriosis in scar tissue located in the distal part of the anterior vaginal wall close to the urethra following repeated urogynaecological surgery. Our case presents a 45-year-old woman diagnosed with pelvic endometriosis in her youth. She underwent several vaginal surgeries due to pelvic organ prolapse, symptoms of stress incontinence and decreased urinary flow. One year after her most recent vaginal surgery, she developed a tender lump in the lower part of the anterior vaginal wall. A urethral diverticulum was suspected, but a diagnostic puncture and biopsy unexpectedly showed histologically verified endometriosis. As the cyst recurred, surgical excision of all visible endometriosis tissue was performed. After 3 years of follow-up, the patient remained without recurrence. This case illustrates the risk of atypical implantation of endometriosis related to repeated urogynaecological surgery and that treatment requires surgery with thorough removal of all visible tissues.


Subject(s)
Endometriosis , Pelvic Organ Prolapse , Urinary Incontinence, Stress , Vaginal Diseases , Adolescent , Endometriosis/diagnosis , Endometriosis/surgery , Female , Humans , Middle Aged , Neoplasm Recurrence, Local , Urinary Incontinence, Stress/etiology , Urinary Incontinence, Stress/surgery , Vaginal Diseases/etiology , Vaginal Diseases/surgery
7.
Ann Hum Biol ; 47(2): 173-180, 2020 Mar.
Article in English | MEDLINE | ID: mdl-32151170

ABSTRACT

Background: Body size in adult life is likely associated with risks of endometriosis and adenomyosis, yet little is known about associations with body size earlier in life.Aim: To examine whether birth weight, childhood body mass index (BMI) and height are associated with risks of endometriosis and adenomyosis.Subjects and methods: From the Copenhagen School Health Records Register, 171,447 girls born 1930-1996, with measured weights and heights at ages 7-13 were included. Outcomes were obtained from health registers. Cox regressions were performed to estimate hazard ratios (HR) and 95% confidence intervals (CI).Results: During follow-up, 2149 endometriosis cases and 1410 adenomyosis cases were diagnosed. Childhood BMI was inversely associated with endometriosis (HR = 0.92 [95% CI: 0.88-0.96] per z-score at age 7). In contrast, childhood height was positively associated with endometriosis (HR = 1.09 [95% CI: 1.05-1.14] per z-score at age 7). Associations with childhood body size did not differ by endometriosis location. Childhood BMI and height had limited associations with adenomyosis. Birth weight was not associated with endometriosis or adenomyosis.Conclusion: Lean and tall girls are more often diagnosed with endometriosis, but not adenomyosis. These findings suggest that indicators of endometriosis risk are already apparent at early ages.


Subject(s)
Adenomyosis/epidemiology , Birth Weight , Body Height , Body Mass Index , Endometriosis/epidemiology , Adenomyosis/etiology , Adolescent , Adult , Aged , Aged, 80 and over , Child , Cohort Studies , Denmark/epidemiology , Endometriosis/etiology , Female , Humans , Infant, Newborn , Middle Aged , Risk Factors , Young Adult
8.
Ann Surg ; 271(1): 106-113, 2020 01.
Article in English | MEDLINE | ID: mdl-29923873

ABSTRACT

OBJECTIVE: To study musculoskeletal workload in experienced surgeons during laparoscopic surgery (LS) compared with robotic assisted laparoscopy (RALS). BACKGROUND: 70-90% of surgeons who regularly perform LS report musculoskeletal symptoms, mainly in neck and shoulders. Data regarding the potential ergonomic benefits of RALS in a clinical setting is very limited. METHODS: Twelve surgeons with advanced experience in both LS and RALS each performed 2 hysterectomies on the same day. LS was performed standing, RALS sitting, the latter allowing forearm and head support. Bipolar surface electromyogram (EMG) was recorded from several muscles and was expressed relative to EMG during maximum contractions (%EMGmax). Gaps per minute plus static (p0.1), mean (p0.5), and peak (p0.9) muscle activation were calculated. Perceived exertion was rated before and just after each surgery. RESULTS: Neck muscle activity (p0.1 4.7 vs. 3.0%EMGmax, p0.5 7.4 vs. 5.3%EMGmax, p0.9 11.6 vs. 8.2%EMGmax, all P < 0.05) and static shoulder muscle activity (p0.1 5.7 vs. 2.8%EMGmax, P < 0.05) were higher for LS than for RALS. Both a higher level of gaps during RALS and a lower rating of perceived exertion, also for the legs, after RALS supported these observations. However, low back muscle activity was higher for RALS. CONCLUSIONS: RALS is significantly less physically demanding than LS, and also feels less strenuous for the surgeons. However, for both types of surgeries, there still is room for improvement of working conditions. To further optimize these, we suggest a scheme to regularly observe and advise the surgeons.


Subject(s)
Burnout, Professional/prevention & control , Clinical Competence , Ergonomics/methods , Laparoscopy/methods , Muscle, Skeletal/physiopathology , Robotic Surgical Procedures/methods , Surgeons/standards , Adult , Aged , Arm/physiology , Burnout, Professional/physiopathology , Cross-Sectional Studies , Electromyography , Female , Humans , Male , Middle Aged
9.
Acta Obstet Gynecol Scand ; 96(6): 751-760, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28181672

ABSTRACT

INTRODUCTION: The objective of this study was to assess obstetrical complications and neonatal outcomes in women with endometriosis as compared with women without endometriosis. MATERIAL AND METHODS: National cohort including all delivering women and their newborns in Denmark 1997-2014. Data were extracted from the Danish Health Register and the Medical Birth Register. Logistic regression analysis provided odds ratios (OR) with 95% confidence intervals (CI). Sub-analyses were made for primiparous women with a singleton pregnancy and for women with endometriosis who underwent gynecological surgery before pregnancy. RESULTS: In 19 331 deliveries, women with endometriosis had a higher risk of severe preeclampsia (OR 1.7, 95% CI 1.5-2.0), hemorrhage in pregnancy (OR 2.3, 95% CI 2.0-2.5), placental abruption (OR 2.0, 95% CI 1.7-2.3), placenta previa (OR 3.9, 95% CI 3.5-4.3), premature rupture of membranes (OR 1.7, 95% CI 1.5-1.8), and retained placenta (OR 3.1, 95% CI 1.4-6.6). The neonates had increased risks of preterm birth before 28 weeks (OR 3.1, 95% CI 2.7-3.6), being small for gestational age (OR 1.5, 95% CI 1.4-1.6), being diagnosed with congenital malformations (OR 1.3, 95% CI 1.3-1.4), and neonatal death (OR 1.8, 95% CI 1.4-2.1). Results were similar in primiparous women with a singleton pregnancy. Gynecological surgery for endometriosis before pregnancy carried a further increased risk. CONCLUSION: Women with endometriosis had a significantly higher risk of several complications, such as preeclampsia and placental complications in pregnancy and at delivery. The newborns had increased risk of being delivered preterm, having congenital malformations, and having a higher neonatal death rate. Pregnant women with endometriosis require increased antenatal surveillance.


Subject(s)
Endometriosis/complications , Infant, Small for Gestational Age , Pregnancy Complications/epidemiology , Premature Birth/epidemiology , Causality , Cesarean Section/statistics & numerical data , Endometriosis/epidemiology , Endometriosis/pathology , Female , Fetal Membranes, Premature Rupture/epidemiology , Humans , Infant, Newborn , Placenta Accreta/epidemiology , Placenta Previa/epidemiology , Postpartum Hemorrhage/epidemiology , Pregnancy , Pregnancy Complications/etiology , Pregnancy Outcome , Risk Factors
10.
Ugeskr Laeger ; 176(49)2014 Dec 01.
Article in Danish | MEDLINE | ID: mdl-25497855

ABSTRACT

Approximately 5-10% of the women in the reproductive age are afflicted with endometriosis and many become pregnant after fertility treatment. Women with endometriosis seem to have an increased risk of placental complications, bleeding in pregnancy and during labour as well as possible increased risk of pre-eclampsia, preterm birth and low birthweight. Large epidemiological studies are needed to clarify the magnitude of these risks in order to define the appropriate level of proactive management of pregnant women with endometriosis.


Subject(s)
Endometriosis/complications , Obstetric Labor Complications/etiology , Endometriosis/pathology , Female , Humans , Pregnancy , Risk Factors
11.
Ugeskr Laeger ; 176(47)2014 Nov 17.
Article in Danish | MEDLINE | ID: mdl-25430535

ABSTRACT

Spontaneous haemoperitoneum in pregnancy has been associated with endometriosis. More women with endometriosis get pregnant due to improved fertility treatment and little is known of their risk of obstetrical complications. We report a case of a pregnant woman with a history of endometriosis who was admitted in gestational week 28 with spontaneous haemoperitoneum. We performed an emergency caesarean section and found multiple varicosities on the surface of uterus with active bleeding. Further knowledge on complications in pregnant women with endometriosis is needed.


Subject(s)
Endometriosis/complications , Hemoperitoneum/etiology , Adult , Cesarean Section , Critical Illness , Endometriosis/pathology , Female , Humans , Obstetric Labor Complications/etiology , Pregnancy , Pregnancy Trimester, Second , Uterus/pathology
12.
Acta Obstet Gynecol Scand ; 93(5): 483-9, 2014 May.
Article in English | MEDLINE | ID: mdl-24617701

ABSTRACT

OBJECTIVE: To assess the reproductive long-term prognosis of women with and without endometriosis, to explore changes over time, and to quantify the contribution of artificial reproductive techniques. DESIGN: Cohort study. SETTING: Denmark 1977-2009. SAMPLE: Data retrieved from four national registries. Among 15-49-year-old women during the period 1977-82, 24 667 were diagnosed with endometriosis and 98 668 (1:4) women without endometriosis were age-matched. METHODS: To assess long-term reproductive prognosis, all pregnancy outcomes were identified among the women with and without endometriosis until the end of 2009. To explore changes over time, the endometriosis cohorts were followed for 15 years from the years 1980, 1986, 1992 and 1998, with the corresponding control cohorts. All pregnancy outcomes were categorized into naturally or artificially conceived pregnancies. MAIN OUTCOME MEASURES: Births, miscarriages, induced abortions, ectopic pregnancies and hydatidiform moles. RESULTS: Compared with women without endometriosis, women with endometriosis had a lowered relative risk for childbirth of 0.93 (95% confidence interval 0.92-0.95), for miscarriages the relative risk was 1.2 (95% confidence interval 1.2-1.3), ectopic pregnancies were almost twice as many (relative risk 1.9, 95% confidence interval 1.8-2.1), while frequencies of induced abortions were equivalent. The chances for childbirth increased over time from 0.82 to 0.92 (p < 0.001) with successive cohorts, but this was restricted to pregnancies from assisted reproduction. CONCLUSION: Women with endometriosis have slightly fewer children, but this lessened over time due to artificially conceived pregnancies. The risk for miscarriages and ectopic pregnancies was increased compared with women without the disease.


Subject(s)
Abortion, Induced/statistics & numerical data , Abortion, Spontaneous/epidemiology , Endometriosis/epidemiology , Hydatidiform Mole/epidemiology , Live Birth/epidemiology , Pregnancy, Ectopic/epidemiology , Uterine Diseases/epidemiology , Adolescent , Adult , Case-Control Studies , Denmark , Female , Humans , Middle Aged , Pregnancy , Prognosis , Reproductive Techniques, Assisted/statistics & numerical data , Time Factors , Young Adult
13.
Eur J Obstet Gynecol Reprod Biol ; 176: 31-3, 2014 May.
Article in English | MEDLINE | ID: mdl-24630302

ABSTRACT

OBJECTIVE: To draw attention to the rare condition of endometriosis in the bladder. This is correlated with symptoms not normally connected to endometriosis and therefore often remains underdiagnosed for years. DESIGN AND SETTING: Retrospective study in a university teaching hospital, one of two referral centres in Denmark for surgical treatment of stage III and IV endometriosis. POPULATION: Thirty-one women with deep infiltrating bladder endometriosis. METHODS: All women presenting in the Department of Obstetrics and Gynaecology with deep infiltrating bladder endometriosis between March 2002 and March 2011. We included only patients with symptomatic full-thickness bladder detrusor endometriosis and mucosal involvement. All patients had had bladder symptoms for two to seven years. MAIN OUTCOME MEASURES: Symptoms after surgery and recurrence rate. RESULTS: The main preoperative symptom was urinary frequency. All patients had significant relief of symptoms after operation, and none had recurrence of the bladder endometriosis judged by ultrasound or reported symptoms. Twenty-six (87%) patients had endometriosis in another location as well. Eight had nodules in the recto-vaginal septum. Complete surgical excision of all associated endometriotic lesions was carried out during the same surgical procedure. During the mean follow-up period of 59 months no long-term complications were diagnosed. CONCLUSION: Bladder endometriosis should be considered in patients who present with irritative urological symptoms with aggravation during menstruation or in patients with a history of endometriosis. When patients have symptoms we recommend surgical treatment in cases where medical treatment fails.


Subject(s)
Endometriosis/pathology , Urinary Bladder Diseases/pathology , Urinary Bladder/surgery , Denmark , Endometriosis/diagnostic imaging , Endometriosis/surgery , Female , Humans , Retrospective Studies , Ultrasonography , Urinary Bladder/diagnostic imaging
14.
Acta Obstet Gynecol Scand ; 93(1): 20-31, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24011403

ABSTRACT

BACKGROUND: Endometriosis is known to harbor characteristics substantiating its possible role as a precursor of ovarian cancer. OBJECTIVE: To assess the quality of the literature regarding the association between endometriosis and ovarian cancer and to estimate the extent of this relation. METHODS: An electronic literature search was conducted in PubMed and 1112 articles dealing with the relation between endometriosis and ovarian cancer were identified. Original articles based on case-control studies, cohort studies and cross-sectional studies were included. Studies consisting of populations with self-reported endometriosis were excluded, as were articles with fewer than 20 cases of ovarian cancer. Twenty-eight studies underwent detailed quality assessments based on the checklists developed by the Scottish Intercollegiate Guidelines Network (SIGN). Meta-analyses were conducted on selected subgroups of ovarian cancer with coexisting endometriosis. RESULTS: None of the 28 studies was given the highest possible rating using the SIGN checklists. The risk of ovarian cancer in women with endometriosis was reported to be a standardized incidence ratio of 1.43-8.95, a rate ratio of 1.6-2.88, an odds ratio of 1.34, with a prevalence of ovarian cancer in 2.0-17.0% of women with endometriosis. Conversely, the prevalence of endometriosis in women with ovarian cancer ranged from 3.4 to 52.6%. Meta-analysis results were weakened by heterogeneity. CONCLUSION: There is sufficient evidence to conclude that there is an increased risk of developing clear-cell and endometrioid epithelial ovarian cancer for women with histologically verified endometriosis. Nonetheless, prospective cohort studies assessing the relation between endometriosis and ovarian cancer will increase knowledge in this field.


Subject(s)
Endometriosis/complications , Ovarian Neoplasms/etiology , Endometriosis/epidemiology , Endometriosis/pathology , Female , Humans , Incidence , Ovarian Neoplasms/epidemiology , Ovarian Neoplasms/pathology , Prevalence , Risk
15.
Gynecol Oncol ; 127(2): 379-83, 2012 Nov.
Article in English | MEDLINE | ID: mdl-22835718

ABSTRACT

OBJECTIVE: Diagnostic factors are needed to improve the currently used serum CA125 and risk of malignancy index (RMI) in differentiating ovarian cancer (OC) from other pelvic masses, thereby achieving precise and fast referral to a tertiary center and correct selection for further diagnostics. The aim was to evaluate serum Human Epididymis protein 4 (HE4) and the risk of ovarian malignancy algorithm (ROMA) for these purposes. METHODS: Serum from 1218 patients in the prospective ongoing pelvic mass study was collected prior to diagnosis. The HE4 and CA125 data were registered and evaluated separately and combined in ROMA and compared to RMI. RESULTS: 809 benign tumors, 79 borderline ovarian tumors, 252 OC (64 early and 188 late stage), 9 non-epithelial ovarian tumors and 69 non-ovarian cancers were evaluated. Differentiating between OC and benign disease the specificity was 62.2 (CA125), 63.2 (HE4), 76.5 (ROMA) and 81.5 (RMI) at a set sensitivity of 94.4 which corresponds to RMI=200. The areas under the curve (AUC) were 0.854 (CA125), 0.864 (HE4), 0,897 (ROMA) and 0.905 (RMI) for benign vs. early stage OC. For premenopausal benign vs. OC AUC were 0.925 (CA125), 0.905 (HE4), 0.909 (ROMA) and 0.945 (RMI). CONCLUSION: HE4 and ROMA helps differentiating OC from other pelvic masses, even in early stage OC. ROMA performs equally well as the ultrasound depending RMI and might be valuable as a first line biomarker for selecting high risk patients for referral to a tertiary center and further diagnostics. Further improvements of HE4 and ROMA in differentiating pelvic masses are still needed, especially regarding premenopausal women.


Subject(s)
Algorithms , Biomarkers, Tumor/blood , CA-125 Antigen/blood , Decision Support Techniques , Membrane Proteins/blood , Neoplasms, Glandular and Epithelial/diagnosis , Ovarian Neoplasms/diagnosis , Pelvic Neoplasms/diagnosis , Proteins/metabolism , Adolescent , Adult , Aged , Aged, 80 and over , Carcinoma, Ovarian Epithelial , Diagnosis, Differential , Female , Humans , Middle Aged , Neoplasms, Glandular and Epithelial/blood , Ovarian Neoplasms/blood , Pelvic Neoplasms/blood , Prospective Studies , Risk Assessment , Sensitivity and Specificity , WAP Four-Disulfide Core Domain Protein 2 , Young Adult
16.
Acta Obstet Gynecol Scand ; 91(4): 496-502, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22229703

ABSTRACT

OBJECTIVE: Risk of malignancy index (RMI), based on a serum cancer antigen 125 level, ultrasound findings and menopausal status, is used to discriminate ovarian cancer from benign pelvic mass. In Denmark, patients with pelvic mass and RMI ≥200 are referred to tertiary gynecologic oncology centers according to the national guidelines for ovarian cancer treatment. The guidelines include recalculation of RMI at the tertiary center and, if indicated, positron emission tomography/computed tomography and fast-track surgery by specialists in cancer surgery. The aim of this study was to validate the use of RMI ≥200 as a tool for preoperative identification of ovarian cancer at a tertiary center. DESIGN: Prospective observational study. SETTING: A tertiary center in Copenhagen, Denmark. POPULATION: One thousand one hundred and fifty-nine women with pelvic mass. METHODS: The RMI was calculated after ultrasound examination and blood sampling for serum cancer antigen 125 analysis within two weeks before surgery. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive values were calculated to evaluate the ability of RMI to distinguish between ovarian cancer and benign pelvic mass. RESULTS: There were 778 women diagnosed with benign pelvic mass, while 251 had ovarian cancer and 74 had borderline ovarian tumor. Fifty-six women were diagnosed with other forms of cancer. Sensitivity and specificity for ovarian cancer vs. benign pelvic mass for RMI ≥200 were 92 and 82%, respectively. Corresponding positive and negative predictive values were 62 and 97%. CONCLUSIONS: Risk of malignancy index ≥200 is a reliable tool for identifying patients with ovarian cancer pelvic masses at a tertiary centre to select patients for further preoperative examinations.


Subject(s)
Decision Support Techniques , Ovarian Neoplasms/diagnosis , Adult , Aged , Aged, 80 and over , CA-125 Antigen/blood , Diagnosis, Differential , Female , Genital Diseases, Female/diagnosis , Humans , Menopause , Middle Aged , Ovarian Neoplasms/blood , Ovarian Neoplasms/diagnostic imaging , Ovarian Neoplasms/surgery , Practice Guidelines as Topic , Predictive Value of Tests , Prospective Studies , ROC Curve , Risk Assessment , Sensitivity and Specificity , Ultrasonography
17.
Gynecol Oncol ; 123(2): 308-13, 2011 Nov.
Article in English | MEDLINE | ID: mdl-21855971

ABSTRACT

BACKGROUND: Previous reports have shown that the proteomic markers apolipoprotein A1, hepcidin, transferrin, inter-alpha trypsin IV internal fragment, transthyretin, connective-tissue activating protein 3 and beta-2 microglobulin may discriminate between a benign pelvic mass and ovarian cancer (OC). The aim was to determine if these serum proteomic biomarkers alone as well as in combination with age and serum CA125, could be helpful in triage of women with a pelvic mass. METHODS: We included prospectively 144 patients diagnosed with (OC), 40 with a borderline tumor and 469 with a benign tumor. Surface-enhanced laser desorption/ionization time of flight-mass spectrometry was used for analyses. The Danish Index (DK-Index) based on the proteomic data, age and CA125 was developed using logistic regression models. RESULTS: Multivariate logistic regression analysis demonstrated that the selected proteomic markers, CA125 and age were independent predictors of OC and the combination of these is proposed as the DK-index. A sensitivity (SN) of 99% had a specificity (SP) of 57% for DK-index and 49% for CA125. At a SN of 95%, the SP increased to 81% for DK-index compared to 68% for CA125 alone. For stage I+II the SP was 58% for DK-index and 49% for CA125. For stage III+IV the corresponding values were 94% and 86% respectively. CONCLUSIONS: The DK-index warrants further evaluation in independent cohorts.


Subject(s)
Biomarkers, Tumor/blood , Neoplasm Proteins/blood , Ovarian Neoplasms/diagnosis , Proteomics , Adult , Aged , Aged, 80 and over , CA-125 Antigen/blood , Female , Humans , Logistic Models , Middle Aged , Odds Ratio , Ovarian Neoplasms/blood , Sensitivity and Specificity
18.
Ugeskr Laeger ; 172(33): 2226-31, 2010 Aug 16.
Article in Danish | MEDLINE | ID: mdl-20727289

ABSTRACT

Rarely, but with increasing frequency, we detect pregnancies within the uterine scar of a prior Caesarean section. These ectopic pregnancies entail a risk of severe bleeding and uterine rupture, and thus constitute a threat to the pregnant woman's life, underlining the necessity of awareness about these complications. Vaginal bleeding and/or mild to moderate lower abdominal pain are symptoms seen in half of the women. The diagnosis is made by sonography and criteria for these are listed. We here present the most recent studies on treatment strategies, follow-up and future fertility.


Subject(s)
Cesarean Section , Cicatrix , Pregnancy, Ectopic , Cesarean Section/adverse effects , Cicatrix/complications , Diagnosis, Differential , Female , Humans , Pregnancy , Pregnancy, Ectopic/diagnostic imaging , Pregnancy, Ectopic/etiology , Pregnancy, Ectopic/therapy , Risk Factors , Ultrasonography , Uterine Rupture/etiology
19.
Eur J Obstet Gynecol Reprod Biol ; 144(1): 48-53, 2009 May.
Article in English | MEDLINE | ID: mdl-19261371

ABSTRACT

OBJECTIVE: The key enzyme in the biosynthesis of estradiol, aromatase, has been demonstrated within endometriosis. Combined administration of aromatase inhibitor and GnRH-agonist may efficiently suppress estrogen biosynthesis through a combined pituitary, ovarian, peripheral and "in situ" action. The aim of this study was to test the concept of combined down-regulation prior to IVF in patients with endometriomas. STUDY DESIGN: Prospective pilot study in a university-based tertiary fertility clinic including 20 infertile patients with endometriomas undergoing IVF/ICSI. The patients received goserelin 3.6mg sc on treatment Days 1, 28 and 56, and one daily tablet of anastrozole 1mg from Day 1 to Day 69. Controlled ovarian stimulation was initiated from Day 70. Outcome measures were change in endometriomal volume and serum CA125 during down-regulation, standard IVF parameters including pregnancy and delivery rate, and endocrine response. The paired T test and Wilcoxon Signed Rank test were used to analyse paired differences. RESULTS: During the combined down-regulation, the endometriomal volume and the serum CA125 level decreased by 29% (3-39%) and 61% (21-74%), respectively (median (95%CI), P=0.007 and P=0.001). In the IVF/ICSI cycle, the number of oocytes retrieved was 7.5 (6.0-10.0) and the fertilization rate was 0.78 (0.38-1.0). Nine patients (45%) conceived, five (25%) had a clinical pregnancy, and three (15%) delivered healthy children (two singletons and one twin). CONCLUSIONS: Prolonged combined anastrozole and goserelin down-regulation significantly reduces endometriomal volume and serum CA125, and is compatible with IVF pregnancy and delivery. However, a high pregnancy loss was noted.


Subject(s)
Aromatase Inhibitors/therapeutic use , Endometriosis/drug therapy , Estrogens/metabolism , Fertilization in Vitro , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Nitriles/therapeutic use , Triazoles/therapeutic use , Uterine Diseases/drug therapy , Adult , Anastrozole , Aromatase Inhibitors/adverse effects , Aromatase Inhibitors/pharmacology , CA-125 Antigen/blood , Down-Regulation/drug effects , Drug Therapy, Combination , Endometriosis/blood , Endometriosis/pathology , Female , Goserelin/pharmacology , Humans , Nitriles/adverse effects , Nitriles/pharmacology , Pilot Projects , Pregnancy , Pregnancy Outcome , Prospective Studies , Triazoles/adverse effects , Triazoles/pharmacology , Uterine Diseases/blood , Uterine Diseases/pathology
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