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INTRODUCTION: Pain experience, physical reaction, image quality and adverse events during Gel Instillation Sonohysterography (GIS) can differ using gels with different compositions. As a result, patient satisfaction can also be affected. The effect of two instillation gels, Endosgel versus ExEmgel, using both the Visual Analogue Scale (VAS) and a Continuous Pain Score Meter (CPSM) was therefore compared. METHODS: This single centre double blind randomised controlled trial included 80 women planned for outpatient GIS, diagnosed with abnormal intrauterine bleeding or fertility disorders and suspicion on an intrauterine abnormality. Patients were randomly allocated to the instillation of Endosgel containing chlorhexidine or ExEmgel without chlorhexidine. Primary outcome was reported pain during the procedure using VAS. Secondary outcomes included pain score measured using CPSM, satisfaction to the procedure and preference at 3 weeks and 3 months after the procedure and image quality. A cost benefit analysis was also performed. RESULTS: The reported median VAS concerning pain during gel instillation was comparable in the Endosgel and ExEmgel group, 2.50 (IQR 0.00-5.00) and 2.00 (IQR 0.00-5.75) respectively (p = 0.69). The median VAS of the entire procedure was also similar: both 2.00 (IQR 0.00-5.00) (p = 0.86). CPSM-scores were not significantly different either. Both groups were similar in image quality (p = 0.83) and patient's satisfaction (p = 0.36). CONCLUSION: Concerning the pain experienced during a GIS procedure and patients' satisfaction, the ExEmgel was not proven to be superior to the Endosgel. Our advice is to use the gel that is available at the lowest costs, as the image quality is the same for both Endosgel and ExEmgel.
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Introduction: Over the past decade, digital education has seen widespread adoption, particularly accentuated during the COVID-19 pandemic. The post-COVID era has further emphasized the advantages of digital education in terms of cost, availability, and sustainability. However, concerns regarding the efficacy of digital education, particularly in skills-based learning and the absence of social interaction, have been raised. This paper will look at the added value of international, face-to-face, skills-based courses. Method: This study evaluates the potential added value of face-to-face international skills courses using the European "Gynecology Experts Training for Upcoming Professionals" (GET-UP) course. Focus group discussions were conducted with participants and faculty members to explore beliefs, attitudes, and perceptions regarding face-to-face learning. Qualitative analysis was performed using thematic analysis to identify domains of added value. Results: The GET-UP course, conducted over 4 days with a diverse European faculty and participants, highlighted several added-value domains. Themes including diversity, role models, preparation, live interaction, and community emerged from the analysis, emphasizing the significance of face-to-face interaction in enriching the learning experience beyond attaining learning goals. Discussion: The study underscores the importance of face-to-face interaction in educational settings, offering insights into diverse teaching methods, role modeling opportunities, enhanced preparation, live interactions, and fostering a sense of community. While digital education continues to evolve with interactive features, this study suggests that the inherent pressure and dynamics of face-to-face learning provide unique benefits that may not be easily replicated in digital environments. Future research should investigate and validate these findings further to inform educational practices effectively.
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INTRODUCTION: After incomplete healing of the uterine cesarean section scar, a niche can be observed; 24% of the women develop large niches with a residual myometrial thickness <3 mm. In these cases a laparoscopic resection is possible. The effect of this new treatment on fertility outcome is not known yet. This paper describes reproductive outcomes 2 years after a laparoscopic niche resection and compares women with or without secondary infertility at baseline. MATERIAL AND METHODS: A prospective cohort study was performed, with consecutive inclusion of women between 2011 and 2019. Women with a niche in the uterine cesarean scar, with a residual myometrial thickness of <3 mm and with a desire to become pregnant, were scheduled to undergo a laparoscopic niche resection because of one or more of the following problems (1) postmenstrual spotting; (2) midcycle intrauterine fluid accumulation diagnosed during the fertility workup or (3) difficulties with a previous embryo transfer and preferring a surgical therapy. The study is registered in the ISRCTN register (ref. no. ISRCTN02271575) on April 23, 2013. RESULTS: There were 133 (62%) women included with a desire to become pregnant, 88 with secondary infertility. In all, 83 had an ongoing pregnancy at the 2-year follow-up. The ongoing pregnancy rate in patients with previous fertility problems was 60.2% compared with 66.7% in patients without infertility (odds ratio [OR] 0.68, 95% confidence interval [CI] 0.32-1.7). The OR for live births was 0.57 (95% CI 0.02-1.2). Overall, 8.3% of the pregnancies resulted in miscarriages by the 2-year follow-up. CONCLUSIONS: The reproductive outcomes in women with and without previous fertility problems undergoing resection of a large niche are very promising and quite comparable in both groups. These results suggest, but do not prove, a beneficial effect of this therapy for these indications. The results support the design of future randomized controlled trials to evaluate the effect of niche resection vs expectant management to assess its additional value in women with or without fertility problems who desire pregnancy.
Subject(s)
Infertility , Laparoscopy , Female , Humans , Pregnancy , Cesarean Section/adverse effects , Cicatrix/etiology , Follow-Up Studies , Infertility/etiology , Laparoscopy/methods , Myometrium/pathology , Prospective StudiesABSTRACT
BACKGROUND: Intrauterine adhesions (IUAs) are one of the main reproductive system diseases in women worldwide. Fusion between the injured opposing walls leads to partial-to-complete obliteration of the cavity and/or cervical canal. The main clinical manifestations in case of IUAs are menstrual disturbances, cyclic pain and reproductive disorders. The reproductive outcomes of women with IUAs remain limited and inefficient compared to women without IUAs, even after adhesiolysis. An exact understanding of the underlying mechanisms and processes to explain the compromised reproductive performance and outcomes in case of IUAs are lacking. METHODS: A systematic literature review of MEDLINE-PubMed (1966 to January 2022) and EMBASE (1974 to January 2022) was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they reported underlying causes, related mechanisms and processes to explain the association between IUAs and impaired reproductive performance, pregnancy and obstetric complications. RESULTS: After an extensive review of the literature, 58 articles were identified reporting underlying mechanisms to explain the association between IUAs and impaired fertility. Intrauterine scarring influences the process of fertilization, reproductive performance and ultimately reproductive outcome. IUAs can disturb the cervico-utero-tubal sperm transport and result in an avascular and unresponsive endometrium with decreased receptivity and thickness. Abnormal decidualization and abnormal trophoblastic infiltration leads to placental attachment disorders. Moreover, the risk for premature delivery, intrauterine fetal growth restriction and fetal anomalies is increased in case of IUAs. CONCLUSION: The impact of IUAs on reproductive performance, even after adhesiolysis, is becoming more apparent. The postulated mechanisms to explain the association are related to sperm transport, embryo implantation and placentation. Prevention, by preserving the basal layer of the endometrium is essential. Effective and evidence-based strategies for the prevention of endometrial injury and formation of IUAs, are urgently needed.
Subject(s)
Hysteroscopy , Uterine Diseases , Male , Female , Pregnancy , Humans , Hysteroscopy/adverse effects , Placenta , Semen , Uterine Diseases/complications , Tissue Adhesions/complicationsABSTRACT
STUDY QUESTION: Are the long-term reproductive outcomes following recurrent dilatation and curettage (D&C) for miscarriage in women with identified and treated intrauterine adhesions (IUAs) comparable to women without IUAs. SUMMARY ANSWER: Reproductive outcomes in women with identified and treated IUAs following recurrent D&C for miscarriage are impaired compared to women without IUAs; fewer ongoing pregnancies and live births are achieved with a prolonged time to a live birth. WHAT IS KNOWN ALREADY: The Prevention of Adhesions Post Abortion (PAPA) study showed that application of auto-crosslinked hyaluronic acid (ACP) gel, an absorbable barrier in women undergoing recurrent D&C for miscarriage resulted in a lower rate of IUAs, 13% versus 31% (relative risk 0.43, 95% CI 0.22 to 0.83), lower mean adhesion score and significant less moderate to severe IUAs. It is unclear what the impact is of IUAs on long-term reproductive performance. STUDY DESIGN, SIZE, DURATION: This was a follow-up of the PAPA study, a multicenter randomized controlled trial evaluating the application of ACP gel in women undergoing recurrent D&C for miscarriage. All included women received a diagnostic hysteroscopy 8-12 weeks after randomization to evaluate the uterine cavity and for adhesiolysis if IUAs were present. Here, we present the reproductive outcomes in women with identified and treated IUAs versus women without IUAs, 46 months after randomization. PARTICIPANTS/MATERIALS, SETTING, METHODS: Between December 2011 and July 2015, 152 women with a first-trimester miscarriage with at least one previous D&C, were randomized for D&C alone or D&C with immediate intrauterine application of ACP gel. Participants were approached at least 30 months after randomization to evaluate reproductive performance, obstetric and neonatal outcomes and cycle characteristics. Additionally, the medical files of all participants were reviewed. Main outcome was ongoing pregnancy. Outcomes of subsequent pregnancies, time to conception and time to live birth were also recorded. MAIN RESULTS AND THE ROLE OF CHANCE: In women pursuing a pregnancy, 14/24 (58%) ongoing pregnancies were recorded in women with identified and treated IUAs versus 80/89 (90%) ongoing pregnancies in women without IUAs odds ratio (OR) 0.18 (95% CI 0.06 to 0.50, P-value <0.001). Documented live birth was also lower in women with IUAs; 13/24 (54%) with versus 75/89 (84%) without IUAs, OR 0.22 (95% CI: 0.08 to-0.59, P-value 0.004). The median time to conception was 7 months in women with identified and treated IUAs versus 5 months in women without IUAs (hazard ratio (HR) 0.84 (95% CI 0.54 to 1.33)) and time to conception leading to a live birth 15 months versus 5.0 months (HR 0.54 (95% CI: 0.30 to 0.97)). In women with identified and treated IUAs, premature deliveries were recorded in 3/16 (19%) versus 4/88 (5%) in women without IUAs, P-value 0.01. Complications were recorded in respectively 12/16 (75%) versus 26/88 (30%), P-value 0.001. No differences were recorded in mean birth weight between the groups. LIMITATIONS, REASONS FOR CAUTION: In the original PAPA study, randomization was applied for ACP gel application. Comparing women with and without IUAs is not in line with the randomization and therefore confounding of the results cannot be excluded. IUAs, if visible during routine hysteroscopy after randomization were removed as part of the study protocol; the influence of IUAs on reproductive outcome may therefore be underestimated. Women undergoing a recurrent D&C for miscarriage were included, a specific group likely to generate clinically significant adhesions. The findings should therefore not be generalized to all women undergoing D&C for miscarriage. WIDER IMPLICATIONS OF THE FINDINGS: As IUAs have an impact on reproductive performance, even after hysteroscopic adhesiolysis, primary prevention is essential. Expectative and medical management should therefore be considered as serious alternatives for D&C in women with a miscarriage. In case D&C is necessary, application of ACP gel should be considered. STUDY FUNDING/COMPETING INTEREST(S): The original PAPA study (NTR 3120) was an investigator initiated study that was funded by the Foundation for scientific investigation in Obstetrics and Gynaecology of the Saint Lucas Andreas Hospital (currently renamed OLVG Oost), SWOGA. The syringes containing ACP gel were received from Anika Therapeutics, the manufacturer of Hyalobarrier® Gel Endo. The current follow-up study was also an investigator-initiated study without funding. The funder and sponsor had no role in the design of this follow-up study, data collection, data analysis, data interpretation, trial design, patient recruitment, writing of the report or any aspect pertinent to the study. ABH, RAL, JAFH and JWRT have no conflict to declare. HAMB reports being a member of safety board research Womed. TRIAL REGISTRATION NUMBER: Netherlands Trial Register NTR 3120.
Subject(s)
Abortion, Spontaneous , Uterine Diseases , Abortion, Spontaneous/surgery , Dilatation and Curettage/adverse effects , Female , Follow-Up Studies , Humans , Infant, Newborn , Netherlands , Pregnancy , Pregnancy Rate , Uterine Diseases/surgeryABSTRACT
OBJECTIVE: To compare pain measured with a new electronic device - the Continuous Pain Score Meter (CPSM) - and the Verbal Rating Scale (VRS) during gynaecological procedures in an outpatient setting, and to correlate these outcomes with baseline anxiety and patient (in)tolerance to the procedure. STUDY DESIGN: This prospective cohort study was undertaken in two centres: a university hospital and a large teaching hospital in The Netherlands. Patients undergoing an outpatient hysteroscopy, colposcopy or ovum pick-up procedure for in-vitro fertilization in one of the two participating hospitals with availability of the CPSM were included. Pain was measured by both the CPSM and the VRS. Patient tolerance to the procedure was reported. Various outcomes of the CPSM were compared with those of the VRS and related to baseline anxiety scores. RESULTS: Ninety-one of 108 included patients (84 %) used the CPSM correctly during the procedure, and it was possible to analyse the CPSM scores for 87 women (81 %). The CPSM scores were all linearly related to the VRS. The peak pain score on the CPSM (CPSM-PPS) had the strongest correlation with the VRS score for all three procedures. Higher CPSM-PPS was related to patient (in)tolerance to the procedure (p = 0.03-0.002). Anxiety at baseline was not correlated with pain perception, except for VRS during colposcopy (r = 0.39, p = 0.016). CONCLUSION: The majority of patients were able to use the CPSM correctly, resulting in detailed information on pain perception for each individual pain stimulus during three outpatient gynaecological procedures. The CPSM-PPS had the strongest correlation with the VRS score and patient (in)tolerance to the procedure.
Subject(s)
Gynecology , Electronics , Female , Humans , Netherlands , Pain Measurement , Pregnancy , Prospective StudiesABSTRACT
OBJECTIVE: To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes. DESIGN: Follow-up of a prospective randomized trial. SETTING: University and university-affiliated teaching hospitals. PATIENT(S): Women with a miscarriage at <14 weeks' gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8-12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed. INTERVENTION(S): Participants received a questionnaire 30 months after treatment. MAIN OUTCOME MEASURE(S): Ongoing pregnancy and outcome of subsequent pregnancies. RESULT(S): Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively. CONCLUSION(S): Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs. DUTCH CLINICAL TRIAL REGISTRY NUMBER: NTR 3120.
Subject(s)
Abortion, Spontaneous/therapy , Dilatation and Curettage , Polysaccharides/administration & dosage , Uterine Diseases/prevention & control , Adult , Dilatation and Curettage/adverse effects , Female , Follow-Up Studies , Gels , Humans , Infant, Newborn , Live Birth , Netherlands , Pregnancy , Pregnancy Rate , Randomized Controlled Trials as Topic , Time Factors , Time-to-Pregnancy , Tissue Adhesions , Uterine Diseases/diagnosis , Uterine Diseases/etiologyABSTRACT
OBJECTIVE: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance. DESIGN: Multicenter prospective randomized trial. SETTING: One university and seven university-affiliated teaching hospitals. PATIENT(S): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed. INTERVENTION(S): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome. MAIN OUTCOME MEASURE(S): Reproductive outcomes during the 12 months after the D&C procedure. RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71% (46/64) and 59.7% (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively. CONCLUSION(S): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.
Subject(s)
Abortion, Spontaneous/drug therapy , Abortion, Spontaneous/surgery , Dilatation and Curettage , Hyaluronic Acid/therapeutic use , Pregnancy Rate , Vaginal Creams, Foams, and Jellies/therapeutic use , Adult , Combined Modality Therapy , Dilatation and Curettage/adverse effects , Dilatation and Curettage/statistics & numerical data , Female , Follow-Up Studies , Humans , Infertility, Female/epidemiology , Infertility, Female/etiology , Netherlands/epidemiology , Pregnancy , Prevalence , Time Factors , Treatment Outcome , Young AdultABSTRACT
Contrast-enhanced ultrasound (CEUS) is an innovative ultrasound technique capable of visualizing both the macro- and microvasculature of tissues. In this prospective pilot study, we evaluated the feasibility of using CEUS to visualize the microvasculature of uterine fibroids and compared CEUS with conventional ultrasound. Four women with fibroids underwent gray-scale ultrasound, sonoelastography and power/color Doppler scans followed by CEUS examination. Analysis of CEUS images revealed initial perfusion of the peripheral rim, that is, a pseudo-capsule, followed by enhancement of the entire lesion through vessels traveling from the exterior to the interior of the fibroid. The pseudo-capsules exhibited slight hyper-enhancement, making a clear delineation of the fibroids possible. The centers of three fibroids exhibited areas lacking vascularization, information not obtainable with the other imaging techniques. CEUS is a feasible technique for imaging and quantifying the microvasculature of fibroids. In comparison with conventional ultrasound imaging modalities, CEUS can provide additional diagnostic information based on the microvasculature.
Subject(s)
Contrast Media , Image Enhancement/methods , Leiomyoma/diagnostic imaging , Ultrasonography/methods , Uterine Neoplasms/diagnostic imaging , Adult , Feasibility Studies , Female , Humans , Leiomyoma/blood supply , Microvessels , Middle Aged , Pilot Projects , Prospective Studies , Uterine Neoplasms/blood supply , Uterus/blood supply , Uterus/diagnostic imagingABSTRACT
The aims of this prospective diagnostic evaluation study were (i) to estimate the inter-observer agreement and reproducibility of real-time sonoelastography and real-time gray-scale ultrasound in the measurement of uterine and fibroid volumes; (ii) to evaluate the agreement between real-time gray-scale ultrasound, sonoelastography and magnetic resonance imaging with respect to these outcomes; and (iii) to evaluate the diagnostic accuracy of sonoelastography in the diagnosis of uterine pathology on stored sonoelastography and gray-scale cine loops. Women without a history of uterine pathology and with the diagnosis intrauterine fibroids or adenomyosis were included. All participants underwent gray-scale ultrasound, sonoelastography and magnetic resonance imaging. Compression sonoelastography was found to have high inter-observer and inter-method agreement for the measurement of uterine and fibroid volumes. The addition of sonoelastography to gray-scale ultrasound seems to be useful in the differentiation between fibroids, adenomyosis and normal uteri as reflected by an increase in accuracy and diagnostic agreement.
Subject(s)
Adenomyosis/diagnostic imaging , Elasticity Imaging Techniques/methods , Leiomyoma/diagnostic imaging , Magnetic Resonance Imaging/methods , Uterine Neoplasms/diagnostic imaging , Adult , Female , Humans , Prospective Studies , Reproducibility of Results , Uterus/diagnostic imagingABSTRACT
OBJECTIVE: To evaluate the implementation and effectiveness of an internet-based perioperative care programme for patients following gynaecological surgery for benign disease. DESIGN: Stepped-wedge cluster randomised controlled trial. SETTING: Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS: 433 employed women aged 18-65 years scheduled for hysterectomy and/or laparoscopic adnexal surgery. INTERVENTIONS: An internet-based care programme was sequentially rolled out using a multifaceted implementation strategy. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or the care programme (n=227). The care programme included an e-health intervention equipping patients with tailored personalised convalescence advice. MAIN OUTCOME MEASURES: The primary outcome was duration until full sustainable return to work (RTW). The degree of implementation of the care programme was evaluated at the level of the patient, healthcare provider and organisation by indicators measuring internet-based actions by patients and providers. RESULTS: Median time until RTW was 49 days (IQR 27-76) in the intervention group and 62 days (42-85) in the control group. A piecewise Cox model was fitted to take into account non-proportionality of hazards. In the first 85 days after surgery, patients receiving the intervention returned to work faster than patients in the control group (HR 2.66, 95% CI 1.88 to 3.77), but this effect was reversed in the small group of patients that did not reach RTW within this period (0.28, 0.17 to 0.46). Indicators showed that the implementation of the care programme was most successful at the level of the patient (82.8%) and professional (81.7%). CONCLUSIONS: Implementation of an internet-based care programme has a large potential to lead to accelerated recovery and improved RTW rates following different types of gynaecological surgeries. TRIAL REGISTRATION NUMBER: NTR2933; Results.
Subject(s)
Convalescence , Gynecologic Surgical Procedures/rehabilitation , Internet , Perioperative Care/methods , Return to Work/statistics & numerical data , Adult , Cross-Over Studies , Female , Humans , Middle Aged , Netherlands , Postoperative Period , Proportional Hazards ModelsABSTRACT
OBJECTIVES: To evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients. DESIGN: Economic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up. SETTING: Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS: 433 employed women aged 18-65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery. INTERVENTION: The intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227). MAIN OUTCOME MEASURES: The primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery. RESULTS: At 12 months, there were no statistically significant differences in total societal costs (-647; 95% CI -2116 to 753) and duration until RTW (-4.1; 95% CI -10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of 56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of 0 per day earlier RTW, which increased to 0.97 at a WTP of 76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs. CONCLUSIONS: Considering that on average the costs of a day of sickness absence are 230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery. TRIAL REGISTRATION NUMBER: NTR2933; Results.
Subject(s)
Hysterectomy/rehabilitation , Internet , Perioperative Care/economics , Return to Work/statistics & numerical data , Sick Leave/economics , Adult , Cost-Benefit Analysis , Female , Humans , Hysterectomy/economics , Laparoscopy , Male , Middle Aged , Netherlands , Quality of Life , Quality-Adjusted Life Years , Regression Analysis , Treatment OutcomeABSTRACT
OBJECTIVES: To investigate the accuracy and reliability of 3-dimensional (3D) transvaginal sonography in classifying submucous fibroids using the International Federation of Gynecology and Obstetrics PALM-COEIN (polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified) classification and protrusion (percent) compared to 2-dimensional (2D) transvaginal sonography, 2D saline infusion sonography, and 3D saline infusion sonography, using hysteroscopy as a reference test. METHODS: A prospective cohort pilot study was performed among 14 consecutive patients undergoing hysteroscopic surgery, preceded by routine sonography (2D transvaginal sonography, 2D saline infusion sonography, 3D transvaginal sonography, and 3D saline infusion sonography). RESULTS: The intraclass correlation coefficient (ICC) for 2D transvaginal sonography versus hysteroscopy was 0.69 (95% confidence interval [CI], 0.06, 0.90) compared to 0.94 (95% CI, 0.83, 0.98) for 2D saline infusion sonography. The ICCs for 3D transvaginal sonography versus hysteroscopy were 0.69 (95% CI, 0.03, 0.90 [investigator A]) and 0.55 (95% CI, -0.48, 0.86 [investigator B]). The ICCs for 3D saline infusion sonography versus hysteroscopy were 0.94 (95% CI, 0.81, 0.98 [investigator A]) and 0.87 (95% CI, 0.60, 0.96 [investigator B]). Interobserver agreement of 3D transvaginal sonography was 0.81 (95% CI, 0.43, 0.94) compared to 0.86 (95% CI, 0.56, 0.96) for 3D saline infusion sonography. CONCLUSIONS: In these preliminary data, 3D transvaginal sonography was not as accurate as 2D or 3D saline infusion sonography and was not more accurate than 2D transvaginal sonography. There was moderate interobserver agreement for 3D transvaginal sonography. There might be room for improvement, as 3D transvaginal sonography is more accurate when endometrial thickness increases. Further study is warranted to evaluate in which patients saline infusion sonography eventually can be obviated.
Subject(s)
Imaging, Three-Dimensional/methods , Leiomyoma/diagnostic imaging , Ultrasonography/methods , Uterine Neoplasms/diagnostic imaging , Adult , Cohort Studies , Female , Humans , Middle Aged , Pilot Projects , Prospective Studies , Reproducibility of Results , Uterus/diagnostic imagingABSTRACT
AIM: To study changes in a ceasarean section (CS) scar during the first year after a CS using gel installation sonography (GIS). METHODS: Proof-of-concept study, prospective cohort study. Twenty women who delivered by their first CS were evaluated by both transvaginal sonography and GIS 2 months and 1 year after CS. A niche was defined as an anechogenic space at the uterine caesarean scar with a depth >2 mm. The primary outcome was any change in the thickness of the residual myometrium (RMT) as evaluated by GIS. RESULTS: Mean RMT changed in time from 11.9 mm at 2 months to 6.5 mm at 12 months after the CS (p < 0.001). Niche prevalence did not change. The adjacent myometrium (AM) reduced from 15 to 12.4 mm (p = 0.04). The ratio between RMT and AM with GIS decreased from 0.80 at 2 months to 0.54 at 12 months (p = 0.002). CONCLUSION: RMT thickness, the adjacent myometium and the ratio between the RMT and AM reduces from 2 to 12 months after a CS. The prevalence did not change. This needs to be taken into account when deciding on the timing of niche measurement and the interpretation of the RMT.
Subject(s)
Cesarean Section , Cicatrix/diagnostic imaging , Myometrium/diagnostic imaging , Adult , Female , Humans , Longitudinal Studies , Pregnancy , Proof of Concept Study , Prospective Studies , UltrasonographyABSTRACT
BACKGROUND: Increased awareness of leiomyosarcoma (LMS) risk during myomectomy or hysterectomy is essential. Objective and correct reasoning should prevail on any decision regarding the extent and type of surgery to employ. The anticipated risk of a sarcoma after myoma or uterus morcellation is low, and the frequency of leiomyosarcoma especially in women below the age of 40 is very rare. The prevalence data has a wide range and is therefore not reliable. The European Society of Gynaecological Endoscopy (ESGE) initiated a survey among its members looking into the frequency of morcellated leiomyosarcoma after endoscopic surgery.The ESGE Central office sent 3422 members a structured electronic questionnaire with multiple answer choices for each question. After 3 months, the answers were classified with a unique number in the EXCEL spread sheet. Statistical analysis was done using the SPSS v.18. RESULTS: Out of 3422 members, 294 (8.6%) gynaecologists replied to the questionnaire; however, only 240 perform myomectomies by laparoscopy and hysteroscopy and hysterectomies by laparoscopy. The reported experience in performing laparoscopic myomectomy, hysteroscopic myomectomy, laparoscopic hysterectomy (LH), and laparoscopic subtotal hysterectomy (LSH) on an average was 10.8 (1-32) years. The vast majority of 67.1% had over 5 years of practice in laparoscopic surgery. The total number of 221 leiomyosarcoma was reported among 429,777 minimally invasive surgeries (laparoscopic and hysteroscopic myomectomies and LH and LSH), performed by all doctors in their lifetime. The overall reported sarcoma risk of all types of endoscopic myoma surgeries has been estimated to be 1.5% of operations which is very rare. Categorizing by type, 57 (0.06%) LMS were operated by laparoscopic myomectomy and 54 (0.07%) by hysteroscopic myomectomy, while 38 (0.13%) leiomyosarcoma operated by laparoscopic subtotal hysterectomy and 72 (0.31%) by laparoscopic hysterectomy. The probability of a sarcoma after morcellation to be falsely diagnosed by histopathology as a benign tumour and later identified as a sarcoma in a later examination has been reported and calculated to be 0.2%. The low risk of a sarcoma is also reflected by the small number of surgeries, where only 32 doctors reported that they operated once, 29 twice, and 18 operated on 3-10 sarcomas by laparoscopy during their lifetime. CONCLUSION: The survey demonstrated that myomectomy by hysteroscopy or laparoscopy has similar risks of sarcoma with an estimated incidence of 0.07%, much lower than that by laparoscopic hysterectomy and subtotal hysterectomy. Hence, for young patients with myoma infertility problem and low risk for LMS, myomectomy by MIS can be the first option of treatment. The fact that only 12.5% (216/1728) of uterine sarcoma cases are operated laparoscopically demonstrates the surgeons' awareness and alertness about LMS and the potential of spreading sarcomatous cells after myoma/uterus power morcellation.
ABSTRACT
The research objective of the current systematic literature review is to classify the laparoscopic niche repair according to the IDEAL framework of 'innovation stages' and to recommend the required research setting to facilitate safe and properly timed implementation of the technique. In doing so, we are also able to evaluate the practical applicability of the IDEAL framework. A systematic search of the available literature on laparoscopic niche repair was performed in PubMed, Embase, and the Wiley/Cochrane library. Articles were classified according to the IDEAL framework and recommendations were given on additional required research before the technique can be safely implemented. Practical applicability of the IDEAL framework was also evaluated. Introduction of laparoscopic niche repair matches Idea (1) and Development (2a), according to the stages of IDEAL framework, although most studies are retrospective and complications have not been registered structurally in a considerable number of the articles. As feasibility and safety have been more or less established and surgery has been further developed we enter stage 2b (Exploration) and need prospective trials preferably comparing the effectiveness of laparoscopic niche repair to expectant management, the current standard care. Available studies were classified with the use of the IDEAL framework, achieving an overall IDEAL stage to be 2a Development. As clinical outcomes, though poorly registered, have been substantially improved, laparoscopic niche repair needs to be carried forward by more advanced study designs.
Subject(s)
Gynecologic Surgical Procedures/methods , Inventions , Laparoscopy/methods , Female , HumansABSTRACT
OBJECTIVE: To study the prevalence of hysteroscopically evaluated disruptions of the integrity of the uterine wall ('niches') in women with and without a previous cesarean section. STUDY DESIGN: A prospective cohort study was performed in a teaching hospital in the Netherlands. Women seeking hysteroscopic sterilization were included. A hysteroscopic evaluation of the anterior wall of the uterus and cervix to identify the existence of disruptions (niches) was performed in a standard manner. Primary outcome was the presence of a uterine niche, defined as any visible defect, disruption, or concavity (gap) in the anterior wall. Secondary outcome was to develop a registration form of niche features for hysteroscopic evaluation. RESULTS: In total, 713 women were included, 603 without and 110 with a previous cesarean section. In women with a previous cesarean Section 83 (75%) niches were observed using hysteroscopy. Anterior wall disruptions were not observed in women without a cesarean section. The following niche features were identified and incorporated in a registration form: polyps, cysts, myometrium defect, fibrotic tissue, (abnormal) vascular pattern, lateral branches, mucus production inside the defect, and bleeding. CONCLUSION: In a prospective cohort study among women undergoing hysteroscopic sterilization, a uterine niche could be detected by hysteroscopy in 75% of women with a previous cesarean section.
Subject(s)
Cesarean Section/adverse effects , Cicatrix/etiology , Uterus/injuries , Adult , Cicatrix/pathology , Female , Humans , Hysteroscopy , Prospective Studies , Uterus/pathologyABSTRACT
BACKGROUND: Focal abnormalities most commonly acquired within the uterine cavity include endometrial polyps (arising from the endometrium) and submucous fibroids (arising from the myometrium). These benign abnormalities can cause several problems, including abnormal uterine bleeding (AUB) and subfertility. Two-dimensional saline infusion sonography (2D SIS) is a minimally invasive test that can be used to diagnose these pathologies, but it is less accurate than hysteroscopy, which is a more invasive procedure by which an endoscope allows direct visualisation of the uterine cavity. Three-dimensional (3D) SIS appears to enhance sonographic visualisation within the uterine cavity, thereby offering a potentially more accurate minimally invasive diagnostic test. OBJECTIVES: Primary objectives ⢠To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test. ⢠To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test. In this case, any abnormality on either modality was regarded as a positive result ('OR' approach). Secondary objectives ⢠To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference.⢠To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference. SEARCH METHODS: We searched the following databases: Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PubMed, Cochrane Gynaecology and Fertility Group (CGF) Specialised Register and CGFG Diagnostic Test Accuracy (DTA) Specialised Register, clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Screening reference lists of appropriate studies was also performed. We screened for eligibility all studies identified from inception until March 2016. We performed searches with no date or language restrictions. SELECTION CRITERIA: The population of interest consisted of premenopausal women with AUB or subfertility and postmenopausal women with AUB. Diagnostic test accuracy studies, randomised controlled trials (RCTs) and prospective cohort studies were eligible for inclusion if they evaluated the accuracy of both 2D SIS and 3D SIS for the diagnosis of acquired intracavitary abnormalities with hysteroscopy used as the reference standard. In light of the lack of data for 3D SIS, we also included studies that evaluated the accuracy of 3D SIS alone. DATA COLLECTION AND ANALYSIS: Two review authors read all potentially eligible references after performing a first screening by title and abstract (LLN and FJRH). They independently extracted data to construct 2×2 tables from eligible studies and assessed studies for methodological quality using the QUADAS-2 tool (revised tool for quality assessment of diagnostic accuracy studies). To describe and visually present results, we produced in RevMan forest plots showing pairs of sensitivity and specificity together with 95% confidence intervals from each study, as well as raw receiver operating characteristic (ROC) plots. We displayed paired analyses in an ROC plot by linking sensitivity-specificity pairs from each study by using a dashed line. To compare 3D SIS versus 2D SIS, we restricted analyses to studies that provided 2×2 tables for both tests and used the bivariate meta-analysis of sensitivity and specificity. MAIN RESULTS: Thirteen studies (1053 women) reported the accuracy of 3D SIS for focal uterine abnormalities; 11 of these (846 women) were suitable for meta-analysis, and eight reported accuracy according to the type of focal abnormality. The design of the included studies seems applicable. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, we considered the overall quality of the evidence as low. The summary estimate (11 studies reporting absence or presence of abnormality at 3D SIS) for sensitivity was 94.5% (95% confidence interval (CI) 90.6% to 96.9%) and for specificity 99.4% (95% CI 96.2% to 99.9%). Meta-analysis of the eight studies (N = 716) directly comparing 2D SIS versus 3D SIS showed summary sensitivity of 96.9% (95% CI 91.9% to 98.8%) and summary specificity of 99.5% (95% CI 96.1% to 100%) for 3D SIS. For 2D SIS, summary sensitivity was 90.9% (95% CI 81.2% to 95.8%) and summary specificity was 96.3% (95% CI 86.1% to 99.1%). The difference in accuracy between 2D SIS and 3D SIS was non-significant (P values of 0.07 for sensitivity and 0.10 for specificity). AUTHORS' CONCLUSIONS: Low-quality evidence suggests that 3D SIS may be very accurate in detecting intracavitary abnormalities. Meta-analysis revealed no statistically significant differences between 2D SIS and 3D SIS. Summary sensitivity and summary specificity are higher for 3D SIS, but margins of improvement are limited because 2D SIS is already very accurate. When the technology and appropriate expertise are available, 3D SIS offers an alternative to 2D SIS. Both 2D SIS and 3D SIS should be considered alternatives to diagnostic hysteroscopy when intracavitary pathology is suspected in subfertile women and in those with abnormal uterine bleeding.
Subject(s)
Endometrium/diagnostic imaging , Leiomyoma/diagnostic imaging , Polyps/diagnostic imaging , Sodium Chloride/administration & dosage , Ultrasonography, Interventional/methods , Uterine Diseases/diagnostic imaging , Female , Humans , Hysteroscopy/standards , Observational Studies as Topic , Prospective Studies , ROC Curve , Randomized Controlled Trials as Topic , Reference Standards , Sensitivity and Specificity , Solutions/administration & dosage , Ultrasonography, Interventional/standards , Uterine Hemorrhage/etiologyABSTRACT
OBJECTIVE: To examine whether intrauterine application of auto-crosslinked hyaluronic acid (ACP) gel, after dilatation and curettage (D&C), reduces the incidence of intrauterine adhesions (IUAs). DESIGN: Multicenter; women and assessors blinded prospective randomized trial. SETTING: University and university-affiliated teaching hospitals. PATIENT(S): A total of 152 women with a miscarriage of <14 weeks with at least one previous D&C for miscarriage or termination of pregnancy. INTERVENTION(S): Women were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A follow-up diagnostic hysteroscopy was scheduled 8-12 weeks after the D&C procedure. MAIN OUTCOME MEASURE(S): The primary outcome was the number of women with IUAs and the secondary outcome was the severity of IUAs. RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The IUAs were observed in 10 (13.0%) and 22 women (30.6%), respectively (relative risk, 0.43; 95% confidence interval 0.22-0.83). Mean adhesion score and the amount of moderate-to-severe IUAs were significantly lower in the intervention group according to the American Fertility Society (AFS) and European Society of Gynecological Endoscopy classifications systems of adhesions. CONCLUSION(S): Intrauterine application of ACP gel after D&C for miscarriage in women with at least one previous D&C seems to reduce the incidence and severity of IUAs but does not eliminate the process of adhesion formation completely. Future studies are needed to confirm our findings and to evaluate the effect of ACP gel on fertility and reproductive outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.