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INTRODUCTION: Since the banning of trans-vaginal meshes for pelvic organ prolapse treatment by the FDA in 2019, French authorities have been gradually regulating the use of prosthetic materials in urogynecology. The decision to fit a mid-urethral sling or a reinforcement implant for the cure of prolapse, as well as the management of complex genital prolapse and serious post-implant complications, must be the subject of multidisciplinary consultation and a shared medical decision. To comply with these regulations, multidisciplinary team meetings (MDTMs) have been set up. The aim of the study was to evaluate the impact of these meetings on patient management. MATERIAL: We carried out a retrospective study in a tertiary hospital in France on all cases presented in MDTM of urogynecology over the year 2022. MDTMs were held weekly, with a "Prosthesis MDTM" focusing on slings, sacrocolpo/hysteropexies and prosthetic complications, lead by the urology team, and a "Prolapse MDTM" focusing on pelvic organ prolapse and complex prolapses, lead by the gynecology team. We compared the initial proposal of the patient's referring physician versus the final proposal of the MDTM. RESULTS: Three hundred and seventy-five cases were presented in our center in 2022: 188 in Prosthetic MDTM and 187 in Prolapse MDTM. The Prosthetic and Static MDTMs agreed with the initial proposal in 83 and 64% of cases respectively, while the therapeutic strategy was questioned in 12 and 36% of cases respectively. CONCLUSION: For almost a quarter (24%) of patients, the MDTM of urogynecology opted for a different management from that proposed by the referring physician. The presentation of cases to the MDTM is a legal obligation in specific indications. It also plays an educational role, enabling shared decision-making and responsibility, which is an asset in functional surgery.
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OBJECTIVE: Surgical introital reduction procedures are commonly performed for the treatment of vaginal laxity (VL), yet poorly studied. The aim of this study was to assess clinical outcomes following surgical vaginal introital reduction for VL. METHODS: This was an ambidirectional cohort study conducted in a single urogynecology center. All sexually active women who had vaginal introital surgical reduction for VL between March 2015 and September 2020 were included in this study. VL was defined as a genital hiatus distance ≥4cm according to the POP-Q classification, associated with symptoms of laxity. The primary endpoint was sexual health assessed by the Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ), while the secondary endpoints included postoperative pain, perioperative complications, rate of dyspareunia, patient satisfaction and success rate based on the Patient Global Improvement Index (PGI-I) and Vaginal Laxity Questionnaire (VLQ). RESULTS: Of the 27 patients sent the questionnaires, 23 sexually active patients returned the completed ones and were included in the study. Participants had a mean age and BMI of 41 years (range 24-74) and 21.3 (range 17.6-31.9) respectively. The most prevalent preoperative symptom was feeling of VL in 82.6% followed by bulging sensation in 47.8%. Preoperative dyspareunia was reported in 8/23 (34.8%). Surgical interventions involved perineorrhaphy with (n=14) or without (n=9) levator ani plication. The PPSSQ mean sexual health score was 86.7/100 (SD 5.8; range 16.7-93.3) and the mean discomfort and pain score was 27.5/100 (SD 26.0; range 0-80). Postoperative sexuality was reported to better, identical or worse in 16 (69.6%), 2 (8.7%) and 5 (21.7%) patients respectively. On PGI-I, patients reported feeling much better, better, slightly better and no change in 10 (43.5%), 5 (21.7%), 5 (21.7%) and 3 (13.0%) respectively. None of the women reported feeling worse. The overall post-operative complication rate was 3/23 (13.0%), including a perineal hematoma, and two cases of reoperation for narrow introitus. De novo dyspareunia was reported by 11/18 (61.1%) patients, occurring often or more in 4/18 (22.2%) patients, due to narrow introitus (n=2), enlarge introitus (n=1) and vaginal dryness (n=1). CONCLUSION: Vaginal introital reduction surgery is a viable treatment option for symptoms of vaginal laxity after failure of conservative measures. However, patients should be made aware of the risk of de novo dyspareunia.
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Dispareunia , Humanos , Feminino , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Dispareunia/etiologia , Dispareunia/terapia , Estudos de Coortes , Vagina/cirurgia , Comportamento Sexual , PelveRESUMO
INTRODUCTION: Obstetric anal sphincter injuries (OASIs) at the time of childbirth can lead to serious consequences including anal incontinence, dyspareunia, pain and rectovaginal fistula. These types of lesions and their incidence have been well studied after cephalic presentation deliveries, but no publications have specifically addressed this issue in the context of vaginal breech delivery. The goal of our study was to evaluate the incidence of OASIs following breech deliveries and compare it with cephalic presentation births. METHODS: This was a retrospective cohort study involving 670 women. Of these, 224 and 446 had a vaginal birth of a fetus in the breech (breech group) and cephalic (cephalic group) presentations respectively. Both groups were matched for birthweight (± 200 g), date of delivery (± 2 years) and vaginal parity. Main outcome of interest was to evaluate the incidence of OASIs following breech vaginal birth compared to cephalic vaginal births. Secondary endpoints were the incidence of intact perineum or first-degree tear, second-degree perineal tear and rates of episiotomies in each group. RESULTS: There was no statistically significant difference in OASIs incidence between the breech and cephalic groups (0.9% vs. 1.1%; RR 0.802 (0.157; 4.101); p = 0.31). There were more episiotomies in the breech group (12.5% vs. 5.4%, p = 0.0012) and the rate of intact or first-degree perineum was similar in both groups (74.1% vs. 75.3%, p = 0.7291). A sub-analysis excluding patients with episiotomy and history of OASIs did not show any statistically significant difference either. CONCLUSION: We did not demonstrate a significant difference in the incidence of obstetric anal sphincter injuries between women who had a breech vaginal birth compared to cephalic.
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Lacerações , Complicações do Trabalho de Parto , Gravidez , Humanos , Feminino , Estudos Retrospectivos , Canal Anal/lesões , Incidência , Fatores de Risco , Parto , Parto Obstétrico/efeitos adversos , Episiotomia/efeitos adversos , Lacerações/epidemiologia , Lacerações/etiologia , Períneo/lesões , Complicações do Trabalho de Parto/epidemiologia , Complicações do Trabalho de Parto/etiologiaRESUMO
The main aim of the study was to evaluate severe post-operative complications following deep endometriosis surgery in a tertiary referral centre. This is a retrospective cohort study that included women who had surgery for deep infiltrating endometriosis between 1st January 2013 and 31st December 2019. Endometriosis was diagnosed based on clinical, imaging and histological parameters. We evaluated the rates of post-operative complications, potential risk factors for such complications and postoperative pregnancy rates. A total of 165 patients were included in the final analysis. The median follow-up was 63 (25-106) months. Thirty-seven patients (22.42%) had hysterectomy, 60 (36.81%) had ureterolysis and 44 (26.67%) had colorectal surgery. The overall and severe rates of post-operative complications were 16.20% (n = 23) and 2.42% (n = 4) respectively. Of the variables assessed, operative time and age were the only statistically significant risk factor for complications on multivariate analysis. Among women operated on for infertility, 34.5% (n = 20/58) got pregnant following surgery with 30% of these spontaneously. This study demonstrates acceptable overall and severe post-operative complications and pregnancy rates after deep endometriosis surgery. This information should help clinicians when counselling women to enable them making an informed choice about their management.
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Procedimentos Cirúrgicos do Sistema Digestório , Endometriose , Infertilidade Feminina , Laparoscopia , Gravidez , Humanos , Feminino , Endometriose/patologia , Estudos Retrospectivos , Taxa de Gravidez , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Infertilidade Feminina/etiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Laparoscopia/métodos , Resultado do TratamentoRESUMO
Hormone therapy (HT) is an effective treatment for metastatic endometrial carcinoma (mEC), with limited toxicity and low cost. We focused on molecular analysis of mECs treated by HT and, for the first time to date, we compared the genomic profiles of paired metastasis and primary ECs. The main objective was to identify predictive factors of the response to HT as well as specific altered signaling pathways driving mEC biology. From 1052 patients with EC treated by HT in two French cancer centers, 32 with endometrioid EC and 6 with high grade serous EC were included. We evaluated hormone receptors (HR) and mismatch repair proteins expression by immunohistochemistry and gene alterations by targeted next-generation sequencing and array-based comparative genomic hybridization. Several variables were tested in univariate and multivariate analyses to identify potential associations with (i) the clinical benefit of HT (CBHT) and (ii) a longer response (>18 months) (LRHT) and overall survival (OS). We compared the biological and genomic profiles of 11 primary/metastatic EC pairs. Thirty tumors (78.9%) were HR-positive and 6 (15.8%) showed microsatellite instability (MSI). The genomic profiles of 34 tumors showed an average altered genome of 3.26%, DNA repair homologous recombination deficiency in five tumors (14.7%), and 17 regions significantly targeted by amplification/deletion. Thirty-three tumors had 273 variants (158 genes, median of 7 mutations/sample), including 112 driver mutations. TP53, PTEN, PPP2R1A, ARID1A, FGFR2, and PIK3CA were the most frequently mutated. Based on the genomic status, nine oncogenic pathways were altered in more than 25% of primary EC. Clinically, 22 (57.9%) and 6 (15.8%) patients presented CBHT and LRHT, respectively. Neither oncogenic pathways alterations nor the variables tested were associated with CBHT and LRHT. Only patient's age, mitotic index and the presence of at least one HR were associated with OS. Paired analysis of the primary/metastatic samples showed that among the 22 mutations acquired in the metastatic counterparts, the most frequently targeted genes were involved in pathways that might confer a selective advantage to cancer metastasis including hormone resistance. In conclusion, only patient's age, mitotic index and the presence of at least one HR were associated with OS. The identification of gene mutations newly acquired in metastasis might help to better understand the formation of EC metastasis and select the best actionable candidates for HT-treated patients at the metastatic stage.
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INTRODUCTION AND HYPOTHESIS: Anterior bilateral sacrospinous ligament fixation (ABSSLF) was first described in 2000 but only evaluated in a limited number of studies. However, due to the FDA's ban on transvaginal mesh, interest in this technique has re-emerged. The SSLF procedure is known for its inherent high risk for anterior compartment failure; hence, in our center we started performing a preemptive concomitant anterior repair with the intention to reduce such risk. The aim of this study was to review the feasibility and clinical outcomes of this innovative technique. METHODS: We performed a retrospective cohort study of all the women who had an ABSSLF and a concomitant anterior native tissue repair between May 2019 and July 2020 in a tertiary hospital in France. Our primary endpoint was surgical feasibility, while as secondary endpoints we wanted to explore the perioperative morbidities and clinical outcomes associated with this technique. RESULTS: A total of 50 women were operated on in the studied period. The median follow-up time was 10 [8.5] months. It was feasible to perform the combined ABSSLF and concomitant anterior native tissue repair in all cases. The most frequent perioperative complications reported were urinary tract infection (14%) and difficulty in resuming voiding (16%). Anatomical and functional results were improved. The rate of anterior compartment recurrence was 37%. CONCLUSIONS: ABSSLF with a concomitant anterior native tissue repair is feasible and relatively safe for treating anterior and apical pelvic prolapse. However, anterior compartment failure rate is still a limitation. Further larger studies with long-term anatomical and functional results comparing this technique to alternative transvaginal surgical approaches are needed.
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Prolapso de Órgão Pélvico , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Procedimentos Cirúrgicos em Ginecologia/métodos , Projetos Piloto , Estudos Retrospectivos , Ligamentos/cirurgia , Resultado do Tratamento , Ligamentos ArticularesRESUMO
OBJECTIVES: The aim of the study was to evaluate the effect of hysterectomy on the risk of complications from transvaginal pelvic organ prolapse surgery with mesh. METHODS: We conducted a retrospective cohort study between October 2010 and December 2017. Transvaginal mesh surgery was performed in patients with symptomatic anterior and/or apical prolapse (Pelvic Organ Prolapse Quantification ≥ stage 2). The primary outcome was rate of severe surgical complications based on the Clavien-Dindo classification (defined as grade ≥3), and the secondary outcome was the anatomical success at the last postoperative follow-up visit. RESULTS: Three hundred and ninety-six patients were included, 289 of these patients underwent anterior sacrospinous fixation with uterine preservation, 50 had a previous hysterectomy and 57 underwent a concomitant hysterectomy. The median follow-up was 12 months (interquartile range, 7 months). The rate of severe complications was 2.1%, 6.0%, and 5.3% in the uterine preservation group, previous hysterectomy group, and concomitant hysterectomy group, respectively (P = 0.2). The operative time was significantly higher in the concomitant hysterectomy group, and the mesh exposure rate was significantly higher in the previous hysterectomy group. The overall recurrence rate was 7.6%, with no differences between the study groups. CONCLUSIONS: Concomitant and previous hysterectomy did not appear to increase the severe complication rate or anatomical failure after transvaginal mesh surgery. However, a history of hysterectomy appears to be a risk factor for vaginal mesh exposure. This must be considered in the choice between prosthetic and autologous management options for the treatment of posthysterectomy vault prolapse.
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Prolapso de Órgão Pélvico , Telas Cirúrgicas , Feminino , Procedimentos Cirúrgicos em Ginecologia , Humanos , Histerectomia/efeitos adversos , Prolapso de Órgão Pélvico/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Fatores de Risco , Telas Cirúrgicas/efeitos adversos , Resultado do TratamentoRESUMO
INTRODUCTION AND HYPOTHESIS: Debate persists over whether surgery to correct pelvic organ prolapse (POP) should be combined with midurethral sling (MUS) insertion. The aim of this study was to evaluate the incidence of stress urinary incontinence (SUI) up to 12 months after transvaginal mesh surgery, with or without MUS, and to identify risk factors for postoperative SUI. METHODS: This retrospective single-center study included patients who underwent transvaginal mesh surgery with Uphold™ between October 2010 and December 2017. The primary outcome was the prevalence of SUI at 12 months postoperatively. Univariate and multivariate logistic regression was used to identify risks factors for postoperative SUI. RESULTS: Of the 308 women included, 123 (40%) were continent (no SUI), 108 (35%) had SUI, and 76 (25%) had occult SUI. Forty-nine patients (15.9%) had a concomitant MUS procedure. At 12 months after surgery, 35.9% of patients without concomitant MUS had SUI vs 14.3% with (p = 0.003). Thirty-five patients (29%) developed de novo SUI. Postoperative complications were more common in patients with concomitant MUS (30.6% vs 17%; p = 0.003). The best predictor of postoperative SUI was the presence of preoperative SUI (OR 2.52 (1.25-5.09). Concomitant MUS (p < 0.001), and prior POP surgery (p = 0.034) were protective factors for postoperative SUI. CONCLUSION: Preoperative SUI is the most important risk factor for postoperative SUI. However, given the higher risk of postoperative complications with concomitant MUS and the acceptable rate of de novo SUI rate without it, two-stage surgery seems preferable for patients with preoperative SUI.
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Prolapso de Órgão Pélvico , Slings Suburetrais , Incontinência Urinária por Estresse , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Estudos Retrospectivos , Fatores de Risco , Slings Suburetrais/efeitos adversos , Telas Cirúrgicas/efeitos adversos , Incontinência Urinária por Estresse/epidemiologia , Incontinência Urinária por Estresse/etiologia , Incontinência Urinária por Estresse/cirurgiaRESUMO
STUDY OBJECTIVE: To study the safety of a degradable polymeric film (DPF) and its efficacy on reducing the risk of intrauterine-adhesion (IUA) formation in a rat model. DESIGN: A series of case-control studies relying on random allocation, where feasible. SETTING: University and good practice animal laboratories. ANIMALS: The animal models comprised female and male Oncins France Strain A and female Wistar rats. INTERVENTION(S) AND MEASUREMENTS: The Oncins France Strain A rats were used for in vivo evaluation of the impact of the DPF on endometrial thickness and its effect on fertility. For in vivo evaluation of the biologic response, 40 Wistar rats were randomly allocated to intervention and control groups, with matched sampling time after surgery. Finally, for the in vivo evaluation of the DPF's efficacy on IUA prevention, a total of 24 Wistar rats were divided into 3 groups: 1 treated with the DPF, 1 treated with hyaluronic acid gel, and a sham group. MAIN RESULTS: The DPF did not have a significant impact on endometrial thickness, and there were no significant differences in the number of conceived or prematurely terminated pregnancies, confirming its noninferiority to no treatment. The DPF did not induce irritation at 5 days and 28 days. Finally, the DPF significantly reduced the likelihood of complete IUA formation compared with hyaluronic acid gel- and sham-implanted animals, where only 27% of the animals had their uterine cavity obliterated compared with 80% and 100%, respectively. CONCLUSION: The DPF is a safe film that is effective in preventing IUA formation after intrauterine curettage in rats.
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Doenças Uterinas , Animais , Estudos de Casos e Controles , Feminino , Humanos , Ácido Hialurônico , Masculino , Gravidez , Ratos , Ratos Wistar , Aderências Teciduais/prevenção & controle , Doenças Uterinas/prevenção & controleRESUMO
INTRODUCTION AND HYPOTHESIS: The use of new lightweight meshes in pelvic organ prolapse (POP) surgery may reduce complications related to mesh retraction (chronic pain, dyspareunia, and mesh exposure). The aim of this study was to investigate changes in the area and position of Uphold Lite™ mesh 6 weeks and 12 months after anterior and/or apical prolapse repair. METHODS: This observational prospective multicenter study included patients who had undergone transvaginal surgery for symptomatic POP-Q stage ≥ II anterior and/or apical compartment prolapse with placement of Uphold Lite mesh. The dimensions and position of the mesh were evaluated at 6 weeks and 12 months by ultrasonography. Correlations between ultrasonographic mesh characteristics and POP recurrence were analyzed. RESULTS: Fifty evaluable women with an average age of 66.8 years were included. No statistically significant difference in mesh area was found between week 6 and month 12 postoperatively, either at rest (1746.92 vs. 1574.48 mm2; p = 0.15) or on Valsalva (1568.81 vs. 1542.98 mm2; p = 0.65). The ROC-AUC of the distance between the mesh and the bladder neck (M-BN) at 6 weeks for predicting cystocele recurrence at 12 months was 0.764 (95% CI 0.573-0.955) at rest and 0.724 (95% CI 0.533-0.916) on Valsalva. An M-BN distance > 12.5 mm could predict cystocele recurrence at month 12 with a sensitivity of 80% and a specificity of 69%. CONCLUSIONS: Ultrasonographic measurements of the Uphold Lite™ mesh appear to remain stable between 6 weeks and 12 months postoperatively. M-BN distance correlates with cystocele recurrence. These results appear to confirm the value of ultrasound in mesh evaluation.
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Cistocele , Prolapso de Órgão Pélvico , Idoso , Feminino , Seguimentos , Humanos , Estudos Prospectivos , Telas Cirúrgicas , Resultado do TratamentoRESUMO
OBJECTIVE: Pregnancy associated breast cancer (PABC) are defined as breast cancer diagnosed during pregnancy and during the year following delivery. The prediction of poor prognosis events (PPE) such as recurrence is a major medical challenge of management for women with PABC. The aim of this study was to build a nomogram based on selected clinical and histological variables to predict recurrence. STUDY DESIGN: This retrospective study included 96 patients with PABC from January 2002 to January 2018. A multivariate Cox analysis of selected risk factors was performed and a nomogram to predict recurrence was built. The nomogram was internally validated. RESULTS: The overall recurrence rate was 22% (21/95) and the 3-years recurrence rate was 13% (12/95). Age at diagnosis, histological type, immuno-histological class, tumor stage (TNM), node stage (TNM) were associated with PPE in univariate analysis, and were included in the final Cox model to develop the nomogram. The predictive model had a concordance index of 0.83 (95% Confidence Interval (CI), 0.81-0.85) and 0.78 (95% CI, 0.76-0.80) before and after the 200 repetitions of bootstrap sample corrections, respectively, and showed a good calibration. CONCLUSION: Our results support the use of the present nomogram based on 5 clinical and pathological characteristics to predict PPE in PABC with a high concordance. External validation is required to recommend this nomogram in routine practice.
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Neoplasias da Mama/epidemiologia , Recidiva Local de Neoplasia/epidemiologia , Nomogramas , Complicações Neoplásicas na Gravidez/epidemiologia , Adulto , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Feminino , França/epidemiologia , Humanos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/diagnóstico , Recidiva Local de Neoplasia/patologia , Gravidez , Complicações Neoplásicas na Gravidez/patologia , Prognóstico , Reprodutibilidade dos Testes , Estudos Retrospectivos , Taxa de SobrevidaRESUMO
INTRODUCTION AND HYPOTHESIS: The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires. RESULTS: Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%). CONCLUSION: Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.
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Prolapso de Órgão Pélvico , Prolapso Uterino , Feminino , França , Procedimentos Cirúrgicos em Ginecologia , Humanos , Estudos Prospectivos , Telas Cirúrgicas , Resultado do Tratamento , Prolapso Uterino/cirurgia , Vagina/cirurgiaRESUMO
AIMS: To evaluate the safety and efficacy of the Uphold LITE mesh in the treatment of pelvic organ prolapse at 12-month follow-up. METHODS: Women undergoing a mesh surgery due to an anterior prolapse plus a symptomatic anterior prolapse (classed as pelvic organ prolapse quantification stage ≥2) were included in this prospective, multicentre, observational study. The primary endpoint was a composite outcome including a good anatomical correction, no prolapse symptoms, and no reintervention for an anterior or apical recurrent prolapse within 12 months of surgery. Secondary outcomes included safety, improvements in quality of life (QoL), and risk factor for recurrence. This study was registered with ClinicalTrials.gov, number NCT01559168. RESULTS: A total of 121 patients were included. Symptomatic and anatomic cure rates were 94% (95 of 101) and 76.8% (76 of 99), respectively. The composite success rate was 72.4% (71 of 98). The rate of reoperation for apical or anterior recurrent prolapse was 3.9% (4 of 103). Anatomical anterior or apical recurrence occurred in 18.2% (18 of 97) and 7.2% (7 of 97) of patients, respectively. The composite success rate was significantly higher in centres where more than 30 patients had been treated (80% vs 50%; P = .045). The rate of serious complication was 5.4% (6 of 111). Improvements were recorded in QoL including sexual function. CONCLUSIONS: The Uphold LITE mesh procedure provides satisfactory outcomes in the treatment of anterior and apical prolapse, particularly in high-volume centres. The rates of adverse effects and reintervention for recurrent prolapse were acceptable.
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Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas , Procedimentos Cirúrgicos Urológicos/métodos , Idoso , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Segurança do Paciente , Prolapso de Órgão Pélvico/psicologia , Estudos Prospectivos , Qualidade de Vida , Recidiva , Reoperação , Fatores de Risco , Resultado do TratamentoRESUMO
Intrauterine adhesions lead to partial or complete obliteration of the uterine cavity and have life-changing consequences for women. The leading cause of adhesions is believed to be loss of stroma resulting from trauma to the endometrium after surgery. Adhesions are formed when lost stroma is replaced by fibrous tissue that join the uterine walls. Few effective intrauterine anti-adhesion barriers for gynecological surgery exist. We designed a degradable anti-adhesion medical device prototype to prevent adhesion formation and recurrence and restore uterine morphology. We focused on ideal degradation time for complete uterine re-epithelialization for optimal anti-adhesion effect and clinical usability. We developed a triblock copolymer prototype [poly(lactide) combined with high molecular mass poly(ethylene oxide)]. Comparative pre-clinical studies demonstrated in vivo anti-adhesion efficacy. Ease of introduction and optimal deployment in a human uterus confirmed clinical usability. This article provides preliminary data to develop an intrauterine medical device and conduct a clinical trial.
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Desenho de Equipamento , Aderências Teciduais/prevenção & controle , Doenças Uterinas/metabolismo , Útero/patologia , Útero/cirurgia , Adulto , Animais , Adesão Celular , Colágeno , Endométrio/patologia , Feminino , Humanos , Técnicas In Vitro , Espectroscopia de Ressonância Magnética , Poliésteres/química , Polietilenoglicóis/química , Distribuição Aleatória , Ratos , Ratos Wistar , Recidiva , ViscosidadeRESUMO
BACKGROUND: Peritoneal adhesions are a serious surgical postoperative complication. The aim of this study is to investigate, in a rat model, the anti-adhesive effects of a bioabsorbable film of polymer combining polyethylene glycol and polylactic acid. MATERIALS AND METHODS: Sixty-three animals were randomized into five groups according to the anti-adhesion treatment: Hyalobarrier®, Seprafilm®, Polymer A (PA), Polymer B (PB), and control. The rats were euthanized on days 5 and 12 to evaluate the extent, severity and degree of adhesions and histopathological changes. Three animals were euthanized at day 2 in PA, PB and control groups to observe the in vivo elimination. RESULTS: Macroscopic adhesion formation was significantly lower in the PA group than in the control group at day 5 (median adhesion score 0±0 vs 9.6 ±0.5 p = 0.002) and at day 12 (0±0 vs 7.3±4 p = 0.02). Furthermore, median adhesion score at day 5 was significantly lower in the PA group than in the Seprafilm group (0±0 vs 4.2± 3.9 p = 0.03). Residence time of PA seems longer than PB. CONCLUSION: The PA bioabsorbable film seems efficient in preventing the formation of peritoneal adhesions.
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Plásticos Biodegradáveis/farmacologia , Membranas Artificiais , Poliésteres/farmacologia , Polietilenoglicóis/farmacologia , Aderências Teciduais/prevenção & controle , Animais , Modelos Animais de Doenças , Feminino , Peritônio/patologia , Peritônio/cirurgia , Ratos , Aderências Teciduais/patologiaRESUMO
STUDY OBJECTIVE: To compare 1.5-Tesla (1.5 T) to 3-Tesla (3 T) Magnetic resonance enterography (MRE) in assessing multifocal (multiple lesions affecting the same segment) and multicentric (multiple lesions affecting several digestive segments) bowel endometriosis in patients with suspected-colorectal endometriosis, in routine practice. STUDY DESIGN: We conducted a retrospective, comparative study in Tenon University Hospital, Paris, France. We included patients scheduled for colorectal resection from April 2014 to February 2018. All patients underwent 1.5 T or 3 T MRE before surgery and endometriosis lesions were confirmed by surgery. The diagnostic performance of 1.5 T and 3 T MRE was evaluated by sensitivity, specificity, positive and negative predictive values (PPV and NPV), accuracy, positive and negative likelihood ratios (LR) and area under the curve of receiver operating curves (AUC ROC). RESULTS: Ninety-eight patients were included. Fifty-two (53%) patients presented unifocal lesions, 31 (32%) multifocal lesions, and 23 (24%) multicentric lesions. In assessment of multifocal lesions, the sensitivity, specificity, positive and negative LRs were 0.57 (12/21), 0.89 (23/26), 4.95 and 0.58 for 1.5 T MRE, and 0.10 (1/10), 0.95 (39/41), 2.05 and 0.95 for 3 T MRE. For the diagnosis of multicentric lesions, 1.5 T MRE showed sensitivity, specificity, positive and negative LRs of 0.46 (5 of 11), 0.92 (33 of 36), 5.45 and 0.60 respectively and 3 T MRE showed sensitivity, specificity, and negative LRs of 0.33 (4/12), 1.00 (39/39), and 0.67, respectively. 1.5 T MRE was more accurate than 3 T MRE for diagnosing multifocal lesions (p = 0.02), but there was no difference for multicentric lesion assessment (p = 0.66). CONCLUSION: In routine conditions, 3 T MRE and 1.5 T MRE are of similar low performance for diagnosing multifocal and multicentric bowel endometriosis.
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Endometriose/diagnóstico por imagem , Enteropatias/diagnóstico por imagem , Imageamento por Ressonância Magnética/estatística & dados numéricos , Adulto , Área Sob a Curva , Feminino , Humanos , Intestinos/diagnóstico por imagem , Funções Verossimilhança , Imageamento por Ressonância Magnética/métodos , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Curva ROC , Estudos Retrospectivos , Sensibilidade e Especificidade , Adulto JovemRESUMO
We investigated whether implementation of a routine catheterization procedure in labor improves covert postpartum urinary retention (cPUR) rates. We conducted a prospective before-after study. 121 women admitted to delivery room in the observational group, and 82 in the intervention group, in a tertiary university hospital in Southern France were included. All patients in the intervention group were systematically catheterized 2 hours after delivery. cPUR was screened for in both groups. The primary end-point was cPUR (post-void residual bladder volume >150 ml when voided volume is >150 mL). The rate of cPUR decreased from 50% (60 out of 121 patients) in the observational group to 17% (14/82) in the intervention group (OR = 0.21; 95% Confidence Interval [0.13;0.58]; p < 0.001). Similarly, in the subgroup of patients who underwent instrumental delivery, the rate of cPUR was lower in the intervention group (18%, 2/11) than in the observational group (65%, 15/23) (p = 0.02). Systematic intermittent bladder catheterization immediately postpartum could decrease cPUR. Further studies are necessary to assess the long-term outcomes and improve understanding of postpartum voiding dysfunction.