Publications by authors named "Martin Rudnicki"

37 Publications

Is abdominal hysterectomy still the surgery of choice in sub-Saharan Africa?

Acta Obstet Gynecol Scand 2021 Jan 18. Epub 2021 Jan 18.

Department of Obstetrics and Gynecology, Kilimanjaro Christian Medical Center, Moshi, Tanzania.

A trend toward minimally invasive surgery is increasing worldwide. However, reports on the extent and the role of vaginal or laparoscopic hysterectomy in benign gynecologic surgery in sub-Saharan Africa are scarce. Our commentary aims to highlight the existing gaps and potential barriers to implementation of vaginal or laparoscopic hysterectomy and suggests how to introduce and expand minimally invasive gynecologic surgery in this region. Little documentation exists in the literature to account for the role of minimally invasive surgery in the sub-Saharan Africa. Hysterectomy for benign reasons is commonly performed by the abdominal approach. This approach is accompanied by significant complications, prolonged hospitalization, and longer recovery duration. Our commentary highlights the importance of investigating region-specific barriers to the practice of minimally invasive gynecologic surgery in sub-Saharan Africa.
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http://dx.doi.org/10.1111/aogs.14087DOI Listing
January 2021

Combined transcervical endometrial resection and levonorgestrel device treatment compared to transcervical endometrial resection for abnormal uterine bleed.

Acta Obstet Gynecol Scand 2020 11 20;99(11):1554-1560. Epub 2020 Jul 20.

Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.

Introduction: Transcervical resection of the endometrium (TCRE) is a first-line surgical treatment of abnormal uterine bleeding. However, many women experience unsuccessful results, causing hysterectomy in up 17% of cases. The aim of this study was to describe the odds of hysterectomy in women with abnormal uterine bleeding, treated with TCRE and levonorgestrel intrauterine contraceptive device (TCRE + LNG-IUCD) or TCRE alone. The secondary aim was to analyze the rate of amenorrhea.

Material And Methods: Designed as a retrospective cohort study, and conducted at Odense University Hospital, Denmark, the study included women with abnormal uterine bleeding, who underwent TCRE from January 2013 to December 2015. The decision of treatment with respect to LNG-IUCD was at the woman's discretion. Data were collected from medical records and a self-reported retrospective bleeding-pattern questionnaire. A multivariate regression model was used, enabling adjustment for potential and identified confounders.

Results: Out of 432 women, 276 (62%) consented to inclusion and of these, 16 (4%) were excluded. In total 88 (34%) received combined treatment and 172 (66%) received TCRE alone. Ten women (11%) treated with TCRE + LNG-IUCD underwent hysterectomy, compared with 27 (16%) treated with TCRE alone (OR = 0.69, 95% CI 0.28-1.56; P = .34). Multivariate analysis disclosed a significant effect of TCRE + LNG-IUCD (OR = 0.35, 95% CI 0.13-0.97; P = .04) on hysterectomy. The presence of fibromas was shown to increase the odds of treatment failure, resulting in hysterectomy (OR 2.69, 95% CI 1.15-6.31; P = .02). Furthermore, the incidence of amenorrhea was 59% in the TCRE + LNG-IUCD group and 36% in the TCRE alone group (OR = 2.56, 95% CI 1.46-4.49; P < .01).

Conclusions: The study showed significantly lower odds of hysterectomy in the TCRE + LNG-IUCD group when adjusted for confounders. Combination treatment improves the bleeding patterns significantly compared with monotherapy with TCRE.
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http://dx.doi.org/10.1111/aogs.13949DOI Listing
November 2020

Robot assisted surgery during the COVID-19 pandemic, especially for gynecological cancer: a statement of the Society of European Robotic Gynaecological Surgery (SERGS).

J Gynecol Oncol 2020 05 3;31(3):e59. Epub 2020 Apr 3.

Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.

All surgery performed in an epicenter of the coronavirus disease 2019 (COVID-19) pandemic, irrespective of the known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) status of the patient, should be regarded as high risk and protection of the surgical team at the bedside should be at the highest level. Robot assisted surgery (RAS) may help to reduce hospital stay for patients that urgently need complex-oncological-surgery, thus making room for COVID-19 patients. In comparison to open or conventional laparoscopic surgery, RAS potentially reduces not only contamination with body fluids and surgical gasses of the surgical area but also the number of directly exposed medical staff. A prerequisite is that general surgical precautions under COVID-19 circumstances must be taken, with the addition of prevention of gas leakage: • Use highest protection level III for bedside assistant, but level II for console surgeon. • Reduce the number of staff at the operation room. • Ensure safe and effective gas evacuation. • Reduce the intra-abdominal pressure to 8 mmHg or below. • Minimize electrocautery power and avoid use of ultrasonic sealing devices. • Surgeons should avoid contact outside theater (both in and out of the hospital).
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http://dx.doi.org/10.3802/jgo.2020.31.e59DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7189073PMC
May 2020

Is robot-assisted laparoscopy safe for surgical treatment of cervical cancer?

Acta Obstet Gynecol Scand 2020 01;99(1):5-6

Minimal Invasive Surgery, Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.

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http://dx.doi.org/10.1111/aogs.13766DOI Listing
January 2020

Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence: a randomized controlled trial.

Int Urogynecol J 2020 08 27;31(8):1545-1550. Epub 2019 Nov 27.

Department of Obstetrics and Gynecology, Skane University Hospital, Lund University, Klinikgatan 12, 221 85, Lund, Sweden.

Introduction And Hypothesis: The objective was to compare the effect of antibiotics versus no antibiotics prophylaxis per-operatively on the frequency of urinary tract infection (UTI) following mid-urethral sling application to treat stress or mixed urinary incontinence.

Methods: This study was designed as a multicenter prospective randomized trial. Women were included from eight centers in three countries. Women were aged under 60 years and had objectively verified stress urinary incontinence. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either antibiotics or no antibiotics. UTI was defined in accordance with the Centers for Disease Control (CDC) criteria for symptomatic UTI. Women were followed up at 3, 12, and 36 months. This was part of a trial comparing subjective cure rate in relation to application of Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings.

Results: The main outcome was to evaluate if per-operative antibiotics had any impact on UTI following sling surgery. In total, 305 women were randomized (158 [52%] to antibiotics and 147 [48%] to no antibiotics). Demographic data disclosed no differences between the two groups. The trial did not show any difference between the two groups regarding the frequency of postoperative UTI. Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs. Per-operative antibiotics had no influence on the frequency of mesh erosions or any other complication.

Conclusions: Our trial does not suggest any beneficial effect of per-operative antibiotics on the risk of post-operative UTIs.
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http://dx.doi.org/10.1007/s00192-019-04156-9DOI Listing
August 2020

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial.

Int Urogynecol J 2019 09 20;30(9):1465-1473. Epub 2019 Jun 20.

Department of Obstetrics and Gynecology, Skane University Hospital, Lund, Sweden.

Introduction And Hypothesis: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence.

Methods: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years.

Results: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS.

Conclusions: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.
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http://dx.doi.org/10.1007/s00192-019-04004-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6706362PMC
September 2019

Two-dimensional (2D) versus three-dimensional (3D) laparoscopy for vaginal cuff closure by surgeons-in-training: a randomized controlled trial.

Surg Endosc 2020 03 6;34(3):1237-1243. Epub 2019 Jun 6.

Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology, Brigham and Women's Hospital, 75 Francis St, Boston, MA, 02115, USA.

Background: Objective evidence is lacking as to the benefit of the addition of 3D vision to conventional laparoscopy in Gynecologic surgery. This study aims to compare 3-D visual system to traditional 2-D laparoscopic visualization for the laparoscopic closure of the vaginal cuff during total laparoscopic hysterectomy by surgeons-in-training [defined as senior OBGYN resident or Minimally Invasive Gynecologic Surgery (MIGS) fellow].

Methods: 51 patients undergoing total laparoscopic hysterectomy at two tertiary care academic hospitals were randomized to two-dimensional or three-dimensional vision system with cuff closure performed by surgeons-in-training. The primary outcome was the time taken for vaginal cuff closure. Secondary outcomes included peri-operative outcomes and assessment of surgeon's perception of ease of cuff closure.

Results: 27 (52.9%) cases were allocated to cuff closure with the 2D system and 24 (47.1%) cases to closure with the 3D vision system. Patient baseline characteristics were similar between the vision systems. Mean vaginal cuff closure time was not significantly different between 2D and 3D vision (10.1 min for 2D versus 12 min for 3D, p = 0.31). An additional 24 s was added to cuff closure time with each 1 kg/m increase in BMI, after controlling for potential confounders (p = 0.003). There was no difference in the surgeon rating of ease of cuff closure between 2D and 3D. Peri-operative outcomes are similar among the two groups.

Conclusion: We did not demonstrate any benefits of 3D vision system over conventional 2D for the task of laparoscopic vaginal cuff suturing performed by surgeons-in-training. RCT Registration Number NCT02192606 https://clinicaltrials.gov/ct2/show/NCT02192606 (July 17, 2014).
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http://dx.doi.org/10.1007/s00464-019-06886-9DOI Listing
March 2020

Feeling lucky: hierarchies of suffering and stories of endometrial cancer in a Danish context.

Sociol Health Illn 2019 06 10;41(5):950-964. Epub 2019 Feb 10.

Research Unit of General Practice, Department of Public Health, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

Illness stories are a prime analytical way of understanding patient perspectives on cancer. Nevertheless, limited studies have focused on stories of endometrial cancer. An ethnographic study including participant observation and interviews among 18 Danish women with endometrial cancer was conducted to examine prevalent stories and the ways the women responded to them. In this article, the analysis focuses on two exemplary cases, which present a line of issues related to the kinds of experiences that suffering includes. Findings illustrate that feelings of luck were central to the experience of being diagnosed, treated and cured, which was related to the way health professionals framed endometrial cancer as favourable through notions of curable/incurable, trivial and gentle/invasive and brutal, and aggressive/non-aggressive. Drawing upon the concept of a 'hierarchy of suffering', we exemplify how women tended to scale own experiences of suffering against others', leading some to believe they were not in a legitimate position to draw attention to themselves nor seek help and support, despite adverse physical, psychosocial effects. Thus, feelings of being lucky were intertwined with a sense of ambivalence. We conclude by discussing how suffering arises within a moral context, suggesting that the ways we speak of cancer may make some experiences unspeakable. This calls for increased clinical attention to more diverse narratives of cancer.
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http://dx.doi.org/10.1111/1467-9566.12875DOI Listing
June 2019

Hysterectomy-Who should be trained to do it?

Acta Obstet Gynecol Scand 2019 06 27;98(6):814. Epub 2019 Feb 27.

OLVG locatie Oost, Amsterdam, the Netherlands.

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http://dx.doi.org/10.1111/aogs.13571DOI Listing
June 2019

Hysterectomy-Should all residents learn to perform it?

Acta Obstet Gynecol Scand 2019 01;98(1):5-6

Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis (OLVG, Our Lady's Guest House Hospital), Amsterdam, The Netherlands.

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http://dx.doi.org/10.1111/aogs.13507DOI Listing
January 2019

"But this is a good cancer:" Patient perceptions of endometrial cancer in Denmark.

J Clin Nurs 2019 Jan 1;28(1-2):245-256. Epub 2018 Aug 1.

Research Unit of General Practice, Department of Public Health, Faculty of Health Sciences, University of Southern Denmark, Odense C, Denmark.

Aims And Objectives: To explore endometrial cancer patients' perceptions of the disease and the influence of favourable prognoses on their experiences.

Background: Endometrial cancer is associated with favourable prognoses, which may imply that patients experience distress to a lesser extent than other cancer patients with less positive treatment outcomes. However, most people with cancer report reduced quality of life and, despite endometrial cancer being prevalent worldwide, experiences of the disease have been little explored.

Design: Ethnographic fieldwork with participant observations and interviews.

Methods: Observations during clinical consultations at two Danish hospitals and interviews with women with endometrial cancer (n = 18) over a period of 6 months. The article adheres to the COREQ guidelines for reporting qualitative research.

Results: We identify how patients consider cancer in general very likely to be fatal, while clinicians in contrast characterise endometrial cancer specifically as "good" because of favourable prognoses. We employ the concept of bricolage to illustrate how bits and pieces of biomedical knowledge and statistical evidence become intertwined with patients' past experiences and subjective ways of knowing, suggesting that patients' perceptions of endometrial cancer as a disease are somewhat dynamic.

Conclusions: Public stories and everyday life experiences of cancer provide a central framework for illness perceptions. As a result, patients retain the idea of a close connection between cancer and death, while also adopting the notion of endometrial cancer as "good". This influenced how women responded to treatment and care. Framing endometrial cancer as "good" is not always helpful, as the impact of a cancer diagnosis per se is rarely favourable.

Relevance To Clinical Practice: In providing women with endometrial cancer with optimal support through diagnosis and treatment, clinicians should attend to the complexity of patients' illness understandings and be aware that assuring patients of a good prognosis not always has the expected impact.
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http://dx.doi.org/10.1111/jocn.14615DOI Listing
January 2019

Questionnaire-based evaluation of sexual life after laparoscopic surgery for endometriosis: a systematic review of prospective studies.

Acta Obstet Gynecol Scand 2018 Sep 29;97(9):1091-1104. Epub 2018 May 29.

Department of Obstetrics & Gynecology, Odense University Hospital, Odense, Denmark.

Introduction: Endometriosis is a benign disease that affects women of reproductive age. Laparoscopic excision of endometriotic implants is considered one of the most effective therapeutic options. The disease and its treatment can have a major impact on psychosexual well-being but this is often overlooked as most studies focus on pain instead of sexuality in a holistic approach. The aim of this study was to review the current literature regarding the effect of laparoscopic surgery for endometriosis on quality of sexual life (QoSL).

Material And Methods: Following the "Preferred Reporting Items for Systematic Reviews and Meta-Analyses" guidelines we conducted a systematic review that involved searching PubMed and Embase databases for prospective studies evaluating the effect of laparoscopic surgery for endometriosis on QoSL, using validated questionnaires.

Results: Of 357 papers, 17 were selected for full text evaluation. Twelve studies using seven different questionnaires fulfilled the inclusion criteria. All studies reported improvements in QoSL following laparoscopic surgery for endometriosis. A meta-analysis could not be performed due to substantial heterogeneity among the included studies arising from differences in questionnaires, follow-up duration, stages of endometriosis, use of hormonal treatment, and missing data.

Conclusions: Laparoscopic excision of endometriosis can improve QoSL. However, there is a need for randomized controlled trials based on a new validated questionnaire regarding specifically QoSL in association with endometriosis. As sexual functioning is a complex phenomenon driven by multiple physical, psychological and social factors, QoSL should be holistically evaluated by a team of different healthcare providers, implementing treatment programs that are individualized to each woman.
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http://dx.doi.org/10.1111/aogs.13369DOI Listing
September 2018

[Uterine fibroids].

Ugeskr Laeger 2017 Oct;179(43)

Uterine fibroids are common, and only women with symptoms need treatment. Hysterectomy has been the most common treatment, but current management strategies offer a wide variety of treatment options ranging from medical, radiological to surgical treatment. The treatment needs to be individualized to each patient according to symptoms, age, number and position of fibroids and wish for future fertility.
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October 2017

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial.

Acta Obstet Gynecol Scand 2017 Nov 15;96(11):1347-1356. Epub 2017 Sep 15.

Department of Obstetrics and Gynecology, Skåne University Hospital, Lund University, Lund, Sweden.

Introduction: The primary aim of this study was to compare the objective and subjective outcomes and short-term complication rates of an adjustable single-incision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS). The secondary aim was to report pain perception and complications at the one-year follow up.

Material And Methods: The study was designed as a multicenter prospective randomized trial where women were included from eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials.gov: NCT01754558. A total of 305 women less than 60 years old with verified stress urinary incontinence were included. All women were randomized to SIMS (Ajust ; n = 155) or SMUS (TVT, TVT-O or TOT; n = 150) and were evaluated by stress test and bladder diary before and after surgery and symptoms related to incontinence using ICIQ-SF, PISQ-12 and PGI-S and PGI-I. Objective cure was defined as no leakage during a stress test and subjective cure defined as no leakage stated in the bladder diary or no indication of urinary leakage in the ICIQ-SF. Furthermore, mesh exposure and dyspareunia were recorded.

Results: In total, 280 women [141 (91%) in the SIMS and 139 (94%) in the SMUS groups] participated in the one-year follow up. No difference between the groups was observed regarding objective and subjective outcomes. VAS score disclosed a lower postoperative pain perception in the SIMS group than in the SMUS group.

Conclusions: Ajust appears to be as efficient as SMUS regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period.
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http://dx.doi.org/10.1111/aogs.13205DOI Listing
November 2017

Predictors and reasons for help-seeking behavior among women with urinary incontinence.

Int Urogynecol J 2018 04 5;29(4):521-530. Epub 2017 Aug 5.

Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.

Introduction And Hypothesis: The aim of the study was to evaluate the predictors and reasons for help-seeking behavior among women with urinary incontinence (UI) in Germany and Denmark.

Methods: This international postal survey was conducted in 2014. In each country, 4,000 women of at least 18 years of age were randomly selected. The questionnaires included validated items regarding help-seeking behavior and the ICIQ-UI SF. UI was defined as any involuntary loss of urine. Binary logistic regression analysis was used to assess factors predicting help-seeking behavior. Reasons for seeking or not seeking help were evaluated in terms of the severity of UI and as the most frequently reported.

Results: Of 1,063 Danish women with UI, 25.3% had consulted a physician compared with 31.4% of 786 German women with UI (p = 0.004). The severity and duration of UI, and actively seeking information regarding UI, were significant independent predictors of help-seeking behavior. Women with slight/moderate UI did not seek help because they did not consider UI as a problem, whereas of women with severe/very severe UI, German women reported that other illnesses were more important and Danish women reported that they did not have enough resources to consult a physician.

Conclusions: Only a small proportion of women with UI had consulted a physician, and the driving forces for help-seeking behavior were severity and duration of UI and actively seeking information regarding UI. Public information campaigns might enhance consultation rates providing that passively receiving and actively seeking information have the same effects on help-seeking behavior. We show for the first time that reasons for not consulting a physician for UI vary depending on the severity of the UI.
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http://dx.doi.org/10.1007/s00192-017-3434-0DOI Listing
April 2018

Systematic review of the limited evidence for different surgical techniques at benign hysterectomy: A clinical guideline initiated by the Danish Health Authority.

Eur J Obstet Gynecol Reprod Biol 2017 Sep 21;216:169-177. Epub 2017 Jul 21.

Department of Obstetrics and Gynecology Aarhus University Hospital, Aarhus, Denmark.

Hysterectomy for benign gynecological conditions is a common operation that has developed extensively through the last 20 years. Methods and surgical techniques vary throughout the regions in Denmark as well as internationally. Consequently, the Danish Health Authority initiated a national clinical guideline on the subject based on a systematic review of the literature. A guideline panel of seven gynecologists formulated the clinical questions for the guideline. A search specialist performed the comprehensive literature search. The guideline panel reviewed the literature and rated the quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Finally, the panel weighted the evidence and formulated the clinical recommendations. Based on the limited available literature and the corresponding quality of evidence according to GRADE, the guideline panel gave the following recommendations: ↓ Subtotal hysterectomy should only be preferred over total hysterectomy after careful consideration because there are documented disadvantages such as persistent cyclic vaginal bleeding (⊕ΟΟΟ). ↑ Consider vaginal hysterectomy rather than conventional laparoscopic hysterectomy for non-prolapsed uteri when feasible (⊕ΟΟΟ). ↓ Robot-assisted laparoscopic hysterectomy should only be preferred over conventional laparoscopic hysterectomy after careful consideration because the beneficial effect is uncertain and because of the longer operating time (⊕⊕ΟΟ). ↑ Consider concomitant bilateral salpingectomy at the time of hysterectomy if the procedure is not considered to increase the risk of complications significantly (⊕ΟΟΟ). ↑ Consider vaginal vault suspension to the cardinal and the uterosacral ligaments when performing hysterectomy for non-prolapsed uteri (⊕ΟΟΟ). Though supporting evidence is missing, the guideline panel emphasizes that it is good practice not to morcellate uteri with presumed fibroids inside the peritoneal cavity (√). The recommendations serve as professional advice in specific clinical situations. The implementation of the guideline in Denmark will be monitored through the national Danish Hysterectomy and Hysteroscopy Database.
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http://dx.doi.org/10.1016/j.ejogrb.2017.07.012DOI Listing
September 2017

When endometriosis is the barrier for fertility.

Acta Obstet Gynecol Scand 2017 06;96(6):621-622

Center for Fetal Medicine, Karolinska University Hospital, Stockholm, Sweden.

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http://dx.doi.org/10.1111/aogs.13155DOI Listing
June 2017

Progesterone resistance in endometriosis: origins, consequences and interventions.

Acta Obstet Gynecol Scand 2017 Jun;96(6):623-632

Department of Obstetrics and Gynecology, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Endometriosis is a common cause of pelvic pain and affects up to 10% of women of reproductive age. Aberrant progesterone signaling in the endometrium plays a significant role in impaired decidualization and establishment of ectopic endometrial implants. Eutopic endometrial cells from women with endometriosis fail to downregulate genes needed for decidualization, such as those involved in cell cycle regulation, leading to unbridled proliferation. Several causes of progesterone resistance in the endometrium have been postulated, including congenital "preconditioning", whereby the in utero environment renders infants susceptible to neonatal uterine bleeding and endometriosis. Progesterone action is crucial to decreasing inflammation in the endometrium, and deviant progesterone signaling results in a proinflammatory phenotype. Conversely, chronic inflammation can induce a progesterone-resistant state. Repetitive retrograde endometrial shedding begets chronic peritoneal inflammation, which further exacerbates progesterone resistance. Genetic causes of progesterone resistance include progesterone receptor gene polymorphisms, altered microRNA expression, and epigenetic modifications to progesterone receptors and their targets. Environmental toxins such as dioxin play a possible role in the genesis of endometriosis by permitting an inflammatory milieu. A consequence of impaired progesterone action is that hormonal therapy is rendered ineffective for a subset of women with endometriosis. Synthetic progestins, such as dienogest, may overcome this phenomenon by increasing progesterone receptor expression and decreasing proinflammatory cytokines. Other modalities include high dose depot formulations of progestins, medicated intrauterine devices and the likely advent of oral GnRH antagonists. Unearthing root causes of progesterone inaction in endometriosis will aid in the development of novel therapeutics geared toward prevention and treatment.
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http://dx.doi.org/10.1111/aogs.13156DOI Listing
June 2017

Surgery versus conservative management of endometriomas in subfertile women. A systematic review.

Acta Obstet Gynecol Scand 2017 Jun;96(6):727-735

Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.

Introduction: Endometriomas are present in up to 44% of all women with endometriosis and have a detrimental effect on fertility. However, it is controversial whether endometriomas should be surgically removed before assisted reproduction technology. Our purpose was to evaluate whether surgical stripping of endometriomas in subfertile women improves the chance of a live birth. Secondary outcomes were impact on ovarian reserve and pain.

Material And Methods: We conducted a systematic review and meta-analysis with results reported in accordance to the PRISMA guidelines. A summary of findings table was developed using GRADE. We searched Medline and Embase. Two reviewers performed the screening.

Results: Of 686 manuscripts, we included one randomized controlled trial and nine retrospective cohort studies, mostly of low quality. The odds ratio for live birth after surgery [compared with conservative management before in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)] was 0.87 (95% CI 0.64-1.18, six studies, I  = 3%; ⨁◯◯◯, VERY LOW quality). The mean difference of antral follicle count was -2.09 (95% CI -4.84 to 0.67, four studies). No difference was observed regarding antral follicle count between the two groups (MD -2.09, 95% CI -4.84 to 0.67, four studies, ⨁◯◯◯, VERY LOW quality). Pain outcome was not reported in the included studies.

Conclusion: The very low quality evidence suggests no difference in odds ratio of live birth between women who underwent surgery for endometriomas before IVF/ICSI compared with conservative management. Further high quality studies are needed, but due to a lack of convincing evidence favoring surgery, we recommend considering conservative treatment if the only indication is subfertility.
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http://dx.doi.org/10.1111/aogs.13154DOI Listing
June 2017

Prevalence of urinary incontinence among women and analysis of potential risk factors in Germany and Denmark.

Acta Obstet Gynecol Scand 2017 Aug 20;96(8):939-948. Epub 2017 May 20.

Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.

Introduction: Urinary incontinence (UI) is a prevalent condition that interferes with women's health-related quality of life. Prevalence rates from earlier studies are wide-ranging, due to heterogeneity in methodology, definition of UI and the populations included. We aimed to determine the prevalence of UI and associated risk factors in Germany and Denmark using the same methodology, definition and population.

Material And Methods: A postal survey was conducted in two regions in Germany and Denmark, including 8000 women aged 18+ years. UI was defined as any complaint of involuntary loss of urine. The questionnaire contained socio-demographic questions and the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF).

Results: The response rate in Germany and Denmark was 46.2 and 66.6% (p < 0.001) and the prevalence rate of UI was 48.3 and 46.4% (p = 0.188), respectively. Stress urinary incontinence dominated among younger women, and urgency urinary incontinence and mixed urinary incontinence among women 80+ years in Germany and Denmark, respectively. The subgroup of women with body mass index (BMI) ≥35 had the highest prevalence of UI (67.3%). The subgroup of women with BMI <35 were more likely to have stress urinary incontinence, and the subgroup of women with BMI ≥35 were more likely to have mixed urinary incontinence. UI was significantly associated with age as with BMI, vaginal delivery, chronic obstructive pulmonary disease, and having at least one co-morbidity.

Conclusions: Prevalence rates in the two regions in Germany and Denmark were similar, despite significantly different response rates. This difference may reflect various attitudes towards answering a questionnaire, but the response rate on questions concerning UI seemed consistent.
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http://dx.doi.org/10.1111/aogs.13149DOI Listing
August 2017

Influence of Body Mass Index on Tumor Pathology and Survival in Uterine Cancer: A Danish Register Study.

Int J Gynecol Cancer 2017 02;27(2):281-288

*Department of Obstetrics and Gynecology, Odense University Hospital, Svendborg; †Research Centre for Prevention and Health, Capital Region of Denmark, Glostrup; and §Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Objective: To evaluate the influence of body mass index (BMI) on endometrial tumor pathology, stage and complication rate and to identify individual prognostic factors, such as BMI, in types I and II endometrial cancer.

Design: Register study included all Danish women who underwent surgery for uterine cancer or atypical endometrial hyperplasia (International Classification of Diseases-10 codes D070, DC549) 2005 to 2012 (n = 6003).

Main Outcome Measures: Impact of BMI on type I and II endometrial cancer survival.

Materials And Methods: Danish Gynecological Cancer Database data on women with type I and II endometrial cancer were retrieved. Kaplan-Meier plot was used to illustrate differences in survival in relation to BMI. Log-rank test was used to demonstrate difference between the curves. Cox regression hazard model was used to estimate hazard ratios (HR) of the effect of BMI on overall survival.

Results: Four thousand three hundred thirty women were included. Women with type I cancer had a significantly better overall survival compared with those with type II cancer. Low BMI was associated with increased mortality in type I (HR, 2.07; 95% confidence interval [CI], 1.20-3.55), whereas in type II both low (HR, 1.68; 95% CI, 1.03-2.74) and high BMI (BMI, 30-35: HR, 1.54; 95% CI, 1.01-2.26 and BMI >40: HR, 2.15; 95% CI, 1.12-4.11) were significantly associated with increased mortality.

Conclusion: Abnormal BMI is associated with increased mortality in subtypes of endometrial cancer. Underweight was associated with increased overall mortality in both types I and II, whereas obesity only disclosed a significant impact on overall mortality in type II.
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http://dx.doi.org/10.1097/IGC.0000000000000874DOI Listing
February 2017

Quality of life after Uphold™ Vaginal Support System surgery for apical pelvic organ prolapse-A prospective multicenter study.

Eur J Obstet Gynecol Reprod Biol 2017 Jan 14;208:86-90. Epub 2016 Nov 14.

University of Helsinki and Helsinki University Central Hospital, Department of Obstetrics and Gynecology, Finland; Folkhälsan Research Center, Helsinki, Finland.

Objective: To study the effects on quality of life in women operated for apical pelvic organ prolapse using the Vaginal Uphold™ System.

Study Design: In this prospective cohort study, women (n=207) with symptomatic apical prolapse, with or without cystocele, were operated using the Uphold™ Vaginal Support System. Follow-up for quality of life was performed at 12 months after surgery, and assessed by the PFDI-20, and PFIQ-7, and sexual function by the PISQ-12. We used odds ratios (ORs) with 95% confidence intervals (CIs) for outcome association analyses using logistic regression.

Results: At one-year follow-up majority of women experienced an overall postoperative improvement in quality of life (p<0.001). One year after surgery Uphold™ operation alone increased the risk for prolapse related bother as compared to Uphold™ combined with anterior colporraphy (POP-IQ-7; OR 2.1; 95% CI 1.01-4.3). The frequency of dyspareunia decreased postoperatively (p=0.004), however, after one-year, overall sexual function deteriorated significantly (p<0.001). The worsening in sexual function scores was mainly attributed to the partner related domain, whereas the behavioral-emotive and physical domains showed no significant changes.

Conclusion: Apical prolapse repair using Uphold™ improved quality of life among our patients but worsened overall sexual function postoperatively.
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http://dx.doi.org/10.1016/j.ejogrb.2016.11.011DOI Listing
January 2017

Laparoscopic surgery for early endometrial cancer.

Acta Obstet Gynecol Scand 2016 Aug 30;95(8):894-900. Epub 2016 May 30.

Department of Obstetrics and Gynecology, Zealand University Hospital, Roskilde, Denmark.

Introduction: The purpose of the present study was to evaluate learning curves and short-term outcomes following laparoscopic surgery for early endometrial cancer in women of different body mass index (BMI) classes.

Material And Methods: Data from 227 women planned for laparoscopic surgery for presumed stage I endometrial cancer were collected retrospectively from a Danish gynecologic oncology unit. Surgery included laparoscopic hysterectomy and bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy (PLA).

Results: Median length of operations was 60 min (range, 30-197) and 120 min (range, 60-230), depending on whether PLA was included. The median pelvic lymph node yield was 18 (range, 7-42). For staging with PLA there was a learning curve when measured as operative time as well as lymph node yield, and a level of proficiency was not reached after 40 operations. The women had a perioperative complication rate of 4.5% and a median hospital stay of one night. Postoperative complication rate was 12%, comprising vaginal cuff hematoma (3.1%), vaginal cuff rupture (0.9%), trocar hernia (1.3%), ureter lesion (0.4%), bowel lesion (0.4%), reoperation (0.9%) and other complications (4.5%). All peri- and postoperative outcomes were independent of BMI classes.

Conclusions: Our data suggest that laparoscopic surgery for early endometrial cancer is feasible and safe. With increasing surgeon's experience there is a significant decrease in operative time and increase in the number of lymph nodes harvested. In experienced hands, either operative time, complications or length of stay are not affected by increasing BMI, even when women are morbidly obese.
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http://dx.doi.org/10.1111/aogs.12908DOI Listing
August 2016

Management of abortion complications at a rural hospital in Uganda: a quality assessment by a partially completed criterion-based audit.

BMC Womens Health 2015 Sep 20;15:76. Epub 2015 Sep 20.

Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.

Background: Complications of unsafe abortion are a major contributor to maternal deaths in developing countries. This study aimed to evaluate the clinical assessment for life-threatening complications and the following management in women admitted with complications from abortions at a rural hospital in Uganda.

Methods: A partially completed criterion-based audit was conducted comparing actual to optimal care. The audit criteria cover initial clinical assessment of vital signs and management of common severe complications such as sepsis and haemorrhage. Sepsis shall be managed by immediate evacuation of the uterus and antibiotics in relation to and after surgical management. Shock by aggressive rehydration followed by evacuation. In total 238 women admitted between January 2007 and April 2012 were included. Complications were categorized as incomplete, threatened, inevitable, missed or septic abortion and by trimester. Actual management was compared to the audit criteria and presented by descriptive statistics.

Results: Fifty six per cent of the women were in second trimester. Abortion complications were distributed as follows: 53 % incomplete abortions, 28 % threatened abortions, 12 % inevitable abortions, 4 % missed abortions and 3 % septic abortions. Only one of 238 cases met all criteria of optimal clinical assessment and management. Thus, vital signs were measured in 3 %, antibiotic criteria was met in 59 % of the cases, intravenous fluid resuscitation was administered to 35 % of women with hypotension and pain was managed in 87 % of the cases. Sharp curettage was used in 69 % of those surgically evacuated and manual vacuum aspiration in 14 %. In total 3 % of the abortions were categorized as unsafe. Two of eight women with septic abortion had evacuation performed during admission-day, one woman died due to septic abortion and one from severe haemorrhage.

Conclusions: Guidelines were not followed and suboptimal assessment or management was observed in all but one case. This was especially due to missing documentation of vital signs necessary to diagnose life-threatening complications, poor fluid resuscitation at signs of shock, and delayed evacuation of septic abortion.
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http://dx.doi.org/10.1186/s12905-015-0233-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576397PMC
September 2015

A novel DICER1 mutation identified in a female with ovarian Sertoli-Leydig cell tumor and multinodular goiter: a case report.

J Med Case Rep 2014 Apr 3;8:112. Epub 2014 Apr 3.

Center for Genomic Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Introduction: Germ-line mutations in the micro-ribonucleic acid processing gene DICER1 have been shown to predispose to a subset of benign tumors susceptible to malignant transformation, including ovarian Sertoli-Leydig cell tumor, nontoxic multinodular goiter, multilocular cystic nephroma and pleuropulmonary blastoma, which can occur in children and young adults. This may be due to reduced Dcr-1 homolog expression in carriers of germline mutations, which causes impairment of micro-ribonucleic acid processing and deregulates the growth and differentiation of target cells, leading to an increased risk of tumorigenesis. Many carriers of germ-line DICER1 mutations remain unaffected, but development of tumors within carriers is associated with varying prognoses.

Case Presentation: Despite the Dcr-1 homolog syndrome phenotype being incompletely defined, a DICER1 mutation was suspected when a girl (case 1 patient) of Danish ethnicity presented with both an ovarian Sertoli-Leydig cell tumor and a multinodular goiter at the age of 13 years. In addition, family history included a male sibling (case 2 patient) who also had a multinodular goiter and had undergone a hemithyroidectomy at the age of 14 years. Subsequent DICER1 screening of the girl identified two novel mutations in exon 21 - a nonsense (c.3647C>A, p.Ser1216*) and a missense (c.3649T>A, p.Tyr1217Asn) mutation. The siblings had inherited the mutations from their father and paternal grandfather, which both currently were asymptomatic, indicating reduced penetrance of the nonsense mutation. Analysis of the parents revealed that the mutations were present in cis, making the contribution of the missense mutation less significant.

Conclusion: We report a novel pathogenic DICER1 mutation (p.Ser1216*) in a Danish family associated with ovarian Sertoli-Leydig cell tumor and a multinodular goiter. A multinodular goiter was diagnosed in the siblings during childhood. Clinicians should be aware of a potential germ-line DICER1 mutation when evaluating multinodular goiter in young patients with or without a family history of thyroid diseases.
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http://dx.doi.org/10.1186/1752-1947-8-112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4234993PMC
April 2014

Assessing HER2 amplification by IHC, FISH, and real-time polymerase chain reaction analysis (real-time PCR) following LCM in formalin-fixed paraffin embedded tissue from 40 women with ovarian cancer.

APMIS 2012 Dec 26;120(12):1000-7. Epub 2012 Jun 26.

Department of Clinical Biochemistry, Hillerød Hospital University of Copenhagen, 3400 Hillerød, Denmark.

We compare HER2 receptor amplification analysis by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and real-time polymerase chain reaction (real-time PCR) DNA copy-number assay following laser capture microdissection (LCM) in formalin-fixed paraffin embedded tissue from 40 women with verified ovarian cancer. We speculate that LCM should result in a more accurate assessment of HER2 amplification in our real-time PCR assay compared with IHC and FISH. HER2 overexpression measured by IHC, FISH, or real-time PCR was found in 5.0%, 5.0%, and 22.5%, respectively. HER2 negative results measured by IHC, FISH, or real-time PCR were found in 95%, 92.5%, and 60.0%, respectively. Analysis failed for IHC, FISH, or real-time PCR in 0%, 2.5%, or 17.5% of cases. Concordance between IHC and FISH, IHC and real-time PCR, or FISH and real-time PCR were 89.7%, 72.7%, or 78.1%, respectively. Only few ovarian cancer patients were HER2 overexpressed measured by IHC or FISH and thus could be eligible for antibody-based therapy with trastuzumab (Herceptin). Interestingly, we find an increased number of HER2 positive patients by real-time PCR analysis on microdissected cancer cells, suggesting a number of HER2 positive patients not detected by current methods. Thus, the concept of quantitative measurement of HER2 on microdissected cancer cells should be explored further.
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http://dx.doi.org/10.1111/j.1600-0463.2012.02929.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533780PMC
December 2012

Clinical outcome after hydrothermal ablation treatment of menorrhagia in patients with and without submucous myomas.

J Minim Invasive Gynecol 2012 Mar-Apr;19(2):212-6. Epub 2012 Jan 31.

Department of Obstetrics and Gynaecology, Roskilde University Hospital, Roskilde, Denmark.

Study Objective: To analyze the long-term efficacy of hydrothermal ablation (HTA) in women with a normal uterine cavity and submucous uterine myomas.

Design: Retrospective study (Canadian Task Force classification II-2).

Setting: Roskilde University Hospital surgical daycare unit.

Patients: One hundred sixty-six consecutive patients with abnormal uterine bleeding who underwent HTA from 2004 to 2008. All patients were asked to fill out a specific questionnaire that included questions related to postoperative bleeding patterns, complications, and satisfaction with the procedure. One hundred thirty-six patients (81.9%) completed the questionnaire, including 33 women (24.3%) with submucous myomas.

Intervention: The HTA procedure was performed in accordance with previous descriptions.

Measurements And Main Results: Mean (SD; 95% CI) follow-up was 33 (10.5; 25.5-31.8) months. Amenorrhea was achieved in 57 women with myomas (55.3%) and 17 women (51.5%) without myomas (p = .47). Postoperative light bleeding was reported in 26 women with myomas (25.2%) and 6 women (18.2%) without myomas. During follow-up, 13 women with myomas (12.6%) underwent hysterectomy, compared with 6 women without myomas (18.2%). Postoperatively, the mean (SD; 95% CI) number of days per month with bleeding was reduced in both groups, from 13.62 (7.90; 11.87-15.37) to 1.34 (2.32; 0.84-1.84) days in the group with myomas, and from 14.78 (8.81; 10.97-18.59), to 1.88 (4.38; 0.12-3.65) without myomas. Similarly, both groups reported improved quality of life: 74.8% and 72.7%, respectively (p = .59). Compared with patients with myomas 3 cm or smaller, patients with myomas larger than 3 cm demonstrated a significantly higher rate of severe bleeding postoperatively (p = .02).

Conclusion: Our results demonstrate that HTA is associated with a high rate of amenorrhea in patients with or without submucous myomas. However, a significantly lower effect may be observed in patients with myomas larger than 3 cm.
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http://dx.doi.org/10.1016/j.jmig.2011.12.011DOI Listing
July 2012

Porcine skin collagen implants for anterior vaginal wall prolapse: a randomised prospective controlled study.

Int Urogynecol J 2010 May 18;21(5):529-34. Epub 2010 Feb 18.

Department of Obstetrics and Gynaecology, Roskilde University Hospital, Roskilde, Denmark.

Introduction And Hypothesis: The effect of a Pelvicol graft compared with a conventional anterior vaginal repair was evaluated in this randomised controlled study.

Methods: Only patients with a stage II or higher (Ba >or= -1) defect were included.

Results: Thirty-one patients were allocated to a conventional anterior repair; 30 to Pelvicol graft. At 12 months follow-up, four patients among controls (15%) and two in the graft group (7%) had objective recurrence. Among controls, the difference at 3 months follow-up in Ba was 6.0 cm when compared with the position of Ba prior to surgery. In the graft group, the difference was 7.0 cm (P < 0.05). This difference was still present at 12 months follow-up (6.0 vs. 7.0 cm; P < 0.05).

Conclusions: The implantation of a Pelvicol graft does not improve the POP-Q stage.
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http://dx.doi.org/10.1007/s00192-009-1018-3DOI Listing
May 2010

Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh.

Neurourol Urodyn 2010 Apr;29(4):527-31

Division of Obstetrics and Gynaecology, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.

Aims: To investigate the urodynamic effects of anterior vaginal wall prolapse surgery using either trocar guided transvaginal mesh or colporraphy.

Methods: A prospective, randomized multicenter trial enrolling 50 patients: 27 underwent anterior colporrhaphy and 23 anterior trocar guided transvaginal mesh. Urodynamic assessment was performed pre- and two months postoperatively.

Results: De novo stress urinary incontinence was significantly more common after trocar guided transvaginal mesh surgery compared to colporraphy. In comparison to baseline urodynamics, transvaginal mesh surgery resulted in a significant decrease in maximal urethral closing pressures (MUCP) whereas conventional anterior colporraphy had no significant effect on urodynamic parameters.

Conclusion: Trocar guided transvaginal mesh of anterior vaginal wall prolapse results in a lowering of MUCPs and increases the risk for de novo stress urinary incontinence compared to colporraphy.
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http://dx.doi.org/10.1002/nau.20811DOI Listing
April 2010