scholarly journals Computed tomographic colonography compared with colonoscopy or barium enema for diagnosis of colorectal cancer in older symptomatic patients: two multicentre randomised trials with economic evaluation (the SIGGAR trials)

2015 ◽  
Vol 19 (54) ◽  
pp. 1-134 ◽  
Author(s):  
Steve Halligan ◽  
Edward Dadswell ◽  
Kate Wooldrage ◽  
Jane Wardle ◽  
Christian von Wagner ◽  
...  

BackgroundComputed tomographic colonography (CTC) is a relatively new diagnostic test that may be superior to existing alternatives to investigate the large bowel.ObjectivesTo compare the diagnostic efficacy, acceptability, safety and cost-effectiveness of CTC with barium enema (BE) or colonoscopy.DesignParallel randomised trials: BE compared with CTC and colonoscopy compared with CTC (randomisation 2 : 1, respectively).SettingA total of 21 NHS hospitals.ParticipantsPatients aged ≥ 55 years with symptoms suggestive of colorectal cancer (CRC).InterventionsCTC, BE and colonoscopy.Main outcome measuresFor the trial of CTC compared with BE, the primary outcome was the detection rate of CRC and large polyps (≥ 10 mm), with the proportion of patients referred for additional colonic investigation as a secondary outcome. For the trial of CTC compared with colonoscopy, the primary outcome was the proportion of patients referred for additional colonic investigation, with the detection rate of CRC and large polyps as a secondary outcome. Secondary outcomes for both trials were miss rates for cancer (via registry data), all-cause mortality, serious adverse events, patient acceptability, extracolonic pathology and cost-effectiveness.ResultsA total of 8484 patients were registered and 5384 were randomised and analysed (BE trial: 2527 BE, 1277 CTC; colonoscopy trial: 1047 colonoscopy, 533 CTC). Detection rates in the BE trial were 7.3% (93/1277) for CTC, compared with 5.6% (141/2527) for BE (p = 0.0390). The difference was due to better detection of large polyps by CTC (3.6% vs. 2.2%;p = 0.0098), with no significant difference for cancer (3.7% vs. 3.4%;p = 0.66). Significantly more patients having CTC underwent additional investigation (23.5% vs. 18.3%;p = 0.0003). At the 3-year follow-up, the miss rate for CRC was 6.7% for CTC (three missed cancers) and 14.1% for BE (12 missed cancers). Significantly more patients randomised to CTC than to colonoscopy underwent additional investigation (30% vs. 8.2%;p < 0.0001). There was no significant difference in detection rates for cancer or large polyps (10.7% for CTC vs. 11.4% for colonoscopy;p = 0.69), with no difference when cancers (p = 0.94) and large polyps (p = 0.53) were analysed separately. At the 3-year follow-up, the miss rate for cancer was nil for colonoscopy and 3.4% for CTC (one missed cancer). Adverse events were uncommon for all procedures. In 1042 of 1748 (59.6%) CTC examinations, at least one extracolonic finding was reported, and this proportion increased with age (p < 0.0001). A total of 149 patients (8.5%) were subsequently investigated, and extracolonic neoplasia was diagnosed in 79 patients (4.5%) and malignancy in 29 (1.7%). In the short term, CTC was significantly more acceptable to patients than BE or colonoscopy. Total costs for CTC and colonoscopy were finely balanced, but CTC was associated with higher health-care costs than BE. The cost per large polyp or cancer detected was £4235 (95% confidence interval £395 to £9656).ConclusionsCTC is superior to BE for detection of cancers and large polyps in symptomatic patients. CTC and colonoscopy detect a similar proportion of large polyps and cancers and their costs are also similar. CTC precipitates significantly more additional investigations than either BE or colonoscopy, and evidence-based referral criteria are needed. Further work is recommended to clarify the extent to which patients initially referred for colonoscopy or BE undergo subsequent abdominopelvic imaging, for example by computed tomography, which will have a significant impact on health economic estimates.Trial registrationCurrent Controlled Trials ISRCTN95152621.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 54. See the NIHR Journals Library website for further project information. Funding was also provided by the UK Department of Health, which stipulated a randomised controlled design but had no involvement in the collection, analysis or interpretation of data, in writing the report, or in the decision to submit for publication. This was also the case for manufacturers who donated equipment for the study (Bracco UK Ltd, High Wycombe, UK; Viatronix Inc., Stony Brook, NY, USA; Medicsight plc, London, UK; Barco Ltd, Bracknell, UK).

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kil-yong Lee ◽  
Jaeim Lee ◽  
Youn Young Park ◽  
Seong Taek Oh

Abstract Background Routine colonoscopy is recommended to determine the coexistence of colon cancer after medical treatment for colon diverticulitis. However, in the case of uncomplicated diverticulitis diagnosed by computed tomography, the clinical relevance of routine follow-up colonoscopy has recently been debated. Yet, the role of follow-up colonoscopy for right colon diverticulitis, which tends to develop at a younger age than left colon diverticulitis, has not been specifically evaluated. Therefore, we aimed to evaluate the incidence of right colon cancer or colonic adenomatous polyps, detected by routine colonoscopy, after conservative management of acute uncomplicated right colon diverticulitis. Methods Patients with uncomplicated right colon diverticulitis (modified Hinchey stage Ia) diagnosed by computed tomography imaging, between 2011 and 2017, and who underwent follow-up colonoscopy surveillance after treatment were included. The primary outcome was the incidence of colon cancer, with the detection rate of adenoma being the secondary outcome. Information for analysis was retrieved retrospectively from patients’ medical records. Results The study group included 330 consecutive patients, with a mean age of 41.9 years, and 51.9% being men. For the primary outcome, the rate of colon cancer on follow-up colonoscopy was 0.3% (1/330 cases). The rate of adenoma detection was 20.9% (69/330 cases) and advanced adenoma (> 10 mm in diameter; or exhibiting a > 25% villous component or severe dysplasia), including colon cancer, was observed in 9 patients (2.7%). Conclusions In patients with acute uncomplicated right colonic diverticulitis, routine colonoscopy after conservative treatment may be necessary because although the colon cancer detection rate is low, it is possible to detect advanced colon adenoma.


Vaccines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1139
Author(s):  
Xiaoguang Li ◽  
Chao Liang ◽  
Xiumei Xiao

This study investigated the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies following inoculation with the coronavirus disease (COVID-19) vaccine. From June to July 2021, 127 participants who had completed COVID-19 vaccination (inactivated SARS-CoV-2 vaccine, 64; CoronaVac, 61; CanSino, 2) were recruited and tested using SARS-CoV-2 neutralizing antibody kits. The positive detection rate (inhibition of neutralizing antibodies ≥ 30%) was calculated and stratified according to population characteristics and inoculation time. The positive rate of neutralizing antibody was 47.22% (17/36) in men and 53.85% (49/91) in women, and 54.55% (24/44) in BMI ≥ 24 and 50.60% (42/83) in BMI < 24. Age was stratified as 20–29, 30–39, 40–49, and ≥50; positive detection rates of SARS-CoV-2 neutralizing antibodies were observed in 60.00% (24/40), 50.00% (21/42), 48.39% (15/31), and 42.86% (6/14), respectively, but with no significant difference (x2 = 1.724, p = 0.632). Among 127 vaccinated participants, 66 (51.97%) were positive. The positive detection rate was 63.93% (39/61) with CoronaVac and 42.19% (27/64) with the inactivated SARS-CoV-2 vaccine (significance x2 = 5.927, p = 0.015). Multivariate analysis revealed a significant difference in vaccination times, with average vaccination weeks in the positive and negative groups of 11.57 ± 6.48 and 17.87 ± 9.17, respectively (t= −4.501, p < 0.001). The positive neutralizing antibody rate was 100.00%, 60.00%, 58.33%, 55.56%, 43.14%, 28.57%, and 0.00% at 2–4, 5–8, 9–12, 13–16,17–20, 21–24, and >24 weeks, respectively (x2 = 18.030, p = 0.006). Neutralizing antibodies were detected after COVID-19 inoculation, with differences relating to inoculation timing. This study provides a reference for vaccine evaluation and follow-up immunization strengthening.


2020 ◽  
Vol 08 (12) ◽  
pp. E1732-E1740
Author(s):  
Alexander J. Eckardt ◽  
Joan Kheder ◽  
Anjali Basil ◽  
Taryn Silverstein ◽  
Krunal Patel ◽  
...  

Abstract Background and study aims Training future endoscopists is essential to meet rising demands for screening and surveillance colonoscopies. Studies have shown conflicting results regarding the influence of trainees on adenoma detection rates (ADR). It is unclear whether trainee participation during screening adversely affects ADR at subsequent surveillance and whether it alters surveillance recommendations. Patients and methods A retrospective analysis of average-risk screening colonoscopies and surveillance exams over a subsequent 10-year period was performed. The initial inclusion criteria were met by 5208 screening and 2285 surveillance exams. Patients with poor preparation were excluded. The final analysis included 7106 procedures, including 4922 screening colonoscopies and 2184 surveillance exams. Data were collected from pathology and endoscopy electronic databases. The primary outcome was the ADR with and without trainee participation. Surveillance recommendations were analyzed as a secondary outcome. Results Trainees participated in 1131 (23 %) screening and in 232 (11 %) surveillance exams. ADR did not significantly differ (P = 0.19) for screening exams with trainee participation (19.5 %) or those without (21.4 %). ADRs were higher at surveillance exams with (22.4 %) and without (27.5 %) trainee participation. ADR at surveillance was not adversely affected by trainee participation during the previous colonoscopy. Shorter surveillance intervals were given more frequently if trainees participated during the initial screening procedure (P = 0.0001). Conclusions ADR did not significantly differ in screening or surveillance colonoscopies with or without trainee participation. ADR at surveillance was not adversely affected by trainee participation during the previous screening exam. However, trainee participation may result in shorter surveillance recommendations.


Author(s):  
Felix Dietlein ◽  
Peter Mueller ◽  
Carsten Kobe ◽  
Heike Endepols ◽  
Melanie Hohberg ◽  
...  

Abstract Purpose PSMA imaging is frequently used for monitoring of androgen deprivation therapy (ADT) in prostate cancer. In a previous study, [18F]-JK-PSMA-7 exhibited favorable properties for tumor localization after biochemical recurrence. In this retrospective study, we evaluated the performance of [18F]-JK-PSMA-7 under ADT. Procedures We examined the performance of [18F]-JK-PSMA-7 in 70 patients (first cohort) with increasing or detectable PSA values under ADT (PSA < 2 ng/ml for 21/70 patients). We further analyzed 58 independent patients with PSA levels < 2 ng/ml under ADT, who were imaged with [68Ga]PSMA-11 or [18F]DCFPyL (second cohort). Finally, we compared detection rates between [18F]-JK-PSMA-7, [68Ga]PSMA-11, and [18F]DCFPyL. Results In the first cohort, we detected [18F]-JK-PSMA-7-positive lesions in 63/70 patients. In patients with PSA levels ≥ 2 ng/ml, the detection rate was 100 % (49/49). In patients with PSA < 2 ng/ml, the detection rate was significantly lower (66.7 %, 14/21, p = 9.7 × 10−5) and dropped from 85.7 % (12/14, PSA levels between 0.3 and 2.0 ng/ml) to 28.6 % (2/7) for PSA levels < 0.3 ng/ml (p = 1.73 × 10−2). In the second cohort (PSA < 2 ng/ml), the detection rate was 79.3 % (46/58) for [68Ga]PSMA-11 or [18F]DCFPyL. Again, the detection rate was significantly higher (p = 1.1 × 10−2) for patients with PSA levels between 0.3 and 2.0 ng/ml (87.0 %, 40/46) relative to those with PSA levels < 0.3 ng/ml (50 %, 6/12). No significant difference was found between [18F]-JK-PSMA-7 and [68Ga]PSMA-11 or [18F]DCFPyL in patients with PSA levels < 2 ng/ml (p = 0.4295). Conclusion [18F]-JK-PSMA-7 PET showed a high detection rate in patients with PSA levels ≥ 0.3 ng/ml under ADT. The lower PSA threshold of 0.3 ng/ml for high detection rates was consistent across the three PSMA ligands. Thus, PSMA imaging is suitable for clinical follow-up of patients with increasing PSA levels under ADT.


2021 ◽  
pp. neurintsurg-2021-017341
Author(s):  
Devin V Bageac ◽  
Blake S Gershon ◽  
Jan Vargas ◽  
Maxim Mokin ◽  
Zeguang Ren ◽  
...  

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.MethodsThis is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.ResultsEach study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.


2021 ◽  
Vol 10 (10) ◽  
pp. 2054
Author(s):  
Gerasimos Kopsinis ◽  
Dimitrios Tsoukanas ◽  
Dimitra Kopsini ◽  
Theodoros Filippopoulos

Conjunctival wound healing determines success after filtration surgery and the quest for better antifibrotic agents remains active. This study compares intracameral bevacizumab to sub-Tenon’s mitomycin C (MMC) in trabeculectomy. Primary open-angle or exfoliative glaucoma patients were randomized to either bevacizumab (n = 50 eyes) or MMC (n = 50 eyes). The primary outcome measure was complete success, defined as Intraocular Pressure (IOP) > 5 mmHg and ≤ 21 mmHg with a minimum 20% reduction from baseline without medications. Average IOP and glaucoma medications decreased significantly in both groups at all follow-up points compared to baseline (p < 0.001), without significant difference between groups at 3 years (IOP: bevacizumab group from 29 ± 9.4 to 15 ± 3.4 mmHg, MMC group from 28.3 ± 8.7 to 15.4 ± 3.8 mmHg, p = 0.60; Medications: bevacizumab group from 3.5 ± 0.9 to 0.5 ± 1, MMC group from 3.6 ± 0.7 to 0.6 ± 1.1, p = 0.70). Complete success, although similar between groups at 3 years (66% vs. 64%), was significantly higher for bevacizumab at months 6 and 12 (96% vs. 82%, p = 0.03; 88% vs. 72%, p = 0.04, respectively) with fewer patients requiring medications at months 6, 9 and 12 (4% vs. 18%, p = 0.03; 6% vs. 20%, p = 0.04; 8% vs. 24%, p = 0.03, respectively). Complication rates were similar between groups. In conclusion, intracameral bevacizumab appears to provide similar long-term efficacy and safety results as sub-Tenon’s MMC after trabeculectomy.


2021 ◽  
Vol 25 (77) ◽  
pp. 1-190
Author(s):  
Kamlesh Khunti ◽  
Simon Griffin ◽  
Alan Brennan ◽  
Helen Dallosso ◽  
Melanie Davies ◽  
...  

Background Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. Objectives To investigate whether or not Walking Away from Diabetes (Walking Away) – a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes – leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Design Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Setting Primary care and the community. Participants Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Interventions Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. Main outcome measures The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. Results A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval –290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval –282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Limitations Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Conclusions Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future work Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Trial registration Current Controlled Trials ISRCTN83465245. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.


Author(s):  
Maurizio Del Monte ◽  
Stefano Cipollari ◽  
Francesco Del Giudice ◽  
Martina Pecoraro ◽  
Marco Bicchetti ◽  
...  

Objectives: To compare the detection rates of overall prostate cancer (PCa) and clinically significant PCa (csPCa) and the median percentage of cancer per biopsy core between MRI-guided In-bore and MRI-TRUS fusion-targeted biopsy (TBx). Methods: In this retrospective study, 223 patients who underwent prostate multiparametric MRI (mpMRI) and subsequent MR-directed biopsy were included. For PCa and csPCa detection rate (DR), contingency tables were tested via the Pearson’s chi-squared to explore the variance of the outcome distribution. The percentage of cancer per biopsy core was tested with a two-tailed Mann-Withney test. Results: One hundred and seventeen and 106 patients underwent MRI-TRUS fusion or MRI In-bore TBx, respectively. 402 MRI biopsy targets were identified, of which 206 (51.2%) were biopsied with the MRI-TRUS TBx and 196 (48.8%) with the MRI In-bore TBx technique. Per-patient PCa and csPCa detection rates were 140/223 (62.8%) and 97/223 (43.5%), respectively. PCa-DR was 73/117 (62.4%) and 67/106 (63.2%) for MRI-TRUS and MRI In-Bore TBx (p = 0.9), while csPCa detection rate reached 50/117 (42.7%) and 47/106 (44.3%), respectively (p = 0.81). The median per-patient percentage of malignant tissue within biopsy cores was 50% (IQR: 27–65%) for PCa and 60% (IQR: 35–68%) for csPCa, with a statistically significant difference between the techniques. Conclusion No statistically significant difference in the detection rate of MRI In-bore and MRI-TRUS fusion TBx was found. MRI In-bore TBx showed higher per-core percentage of malignant cells. Advances in knowledge MRI In-bore biopsy might impact risk stratification and patient management considering the higher per-core percentage of malignant cells, especially for patients eligible for active surveillance or focal therapy.


2021 ◽  
Author(s):  
Shuyi Liang ◽  
Zhifeng Li ◽  
Nan Zhang ◽  
Xiaochen Wang ◽  
Jianli Hu

Abstract Background Severe fever with thrombocytopenia syndrome (SFTS) is a novel infectious disease caused by severe fever with thrombocytopenia syndrome virus (SFTSV). Currently, SFTS is endemic to some areas in China, and wild animals are considered to play important roles in the circulation of SFTSV in the environment. Wild animals monitoring for SFTSV has been fulfilled since 2014 in Jiangsu Province. We studied the results of the detection to provide basic data for better diagnosis of wild animals. Methods This research was conducted in Jiangsu Province from 2014 to 2019. Sera of wild animals (Rodents, pheasants and hedgehogs) were collected to detect SFTSV both RNA and total antibodies by qRT-PCR and enzyme-linked immunosorbent assay. Statistical analysis was performed by using SPSS 25.0 (Chicago, IL, USA).Results A total of 95.8% (1298/1355) of the specimens had the same SFTSV RNA and total antibodies detection results. However, there was a significant difference between the detection rates of SFTSV RNA and total antibodies, and the detection consistency was very poor. The detection rate of SFTSV total antibodies was highest in hedgehogs(19.54%).Conclusions SFTSV total antibodies testing was preferred method during wild animals surveillance. Also, hedgehog could be a competent reservoir for SFTSV.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
E Karataş ◽  
B E Temiz ◽  
S Mumusoglu ◽  
H Yarali ◽  
G Bozdag

Abstract Study question Does utilization of dienogest make any impact on the size of cyst and Anti-Müllerian Hormone (AMH) concentration in patients with endometrioma throughout 12-months? Summary answer Although dienogest makes a gradual reduction in the size of endometrioma cyst throughout 12-months, a significant drop in AMH serum concentration was also noticed. What is known already According to recent studies, pre-operative serum AMH levels might be illusively increased with parallel to the size of endometrioma which will be a misleading factor while deciding to operate the patient via cystectomy. Although dienogest is one of the medical options that might be commenced in patients with endometrioma cyst, there is limited data about its effect on the size of the endometrioma and hence serum AMH concentration throughout 12 months of follow up. Study design, size, duration The current observational cohort study was conducted among patients with endometrioma those treated with dienogest from January 2017 to January 2020. The primary outcome was alteration in diameter of endometrioma cyst at 6th and 12th months of treatment. Secondary outcome was alteration in serum AMH concentration in the same period. Of 104 patients treated with dienogest, 44 patients were excluded due to being treated with any type of surgical intervention during follow up period. Participants/materials, setting, methods A total of 60 patients were recruited for the final analysis. Of them, primary symptom was dysmenorrhea, chronic pelvic pain and menstrual irregularity in 16 (26.7%), 25 (41.7%) and 8 (13.3%) patients, respectively. Eighteen patients (30%) were asymptomatic. As 21 patients had bi-lateral endometrioma, size of the leading cyst was considered to be analyzed for the primary outcome measure. Paired-t test was used for comparison of numerical values and p ≤ 0.05 was taken as statistical significance. Main results and the role of chance The mean age was 31.5±8.0 years. In the time point when dienogest was started, the mean size of the endometrioma was 46.3±17.4 mm. The mean serum AMH concentration was 3.6±2.4 ng/ml. After 6 months of treatment, the mean size of the endometrioma decreased to 38.6±14.0 mm which corresponds to a mean difference of 7.8 mm (95% CI: 3.0 to 12.6; p: 0.003). The respective figure for AMH was 3.3±2.7 ng/ml which corresponds to a mean difference of 0.3 ng/ml (95% CI: –0.2 to 0.8; p: 0.23) at 6 months. After 12 months of treatment, the mean size of the endometrioma was 37.5±15.7 mm which corresponds to a mean difference of 8.9 mm (95% CI: 2.9 to 14.9; p: 0.005) at the end of 12 months. The respective figure for AMH was 2.7±1.9 ng/ml which corresponds to a mean difference of 0.9 ng/ml (95% CI: 0.1 to 1.7; p: 0.045) at the end of 12 months. The mean diameter of endometrioma and AMH concentration did not differ throughout the time period between 6th and 12th months of the treatment. Limitations, reasons for caution Although herein we present the largest data that depicts the alteration of endometrioma cyst and AMH concentration with the application of dienogest, the lack of control group is a limitation that avoids to perform any comparison. Wider implications of the findings: A shrinkage after commencement of treatment suggest that dienogest might present improvement in patients with endometrioma with respect to radiological findings, but further studies are required whether a decline in AMH concentration after 12 months refers to a genuine decrease in ovarian reserve or resolution of misleading high pre-treatment levels. Trial registration number not available


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