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1.
N Engl J Med ; 390(9): 819-829, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38416430

RESUMO

BACKGROUND: Retrospective data suggest that the incidence of parametrial infiltration is low in patients with early-stage low-risk cervical cancer, which raises questions regarding the need for radical hysterectomy in these patients. However, data from large, randomized trials comparing outcomes of radical and simple hysterectomy are lacking. METHODS: We conducted a multicenter, randomized, noninferiority trial comparing radical hysterectomy with simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion). The primary outcome was cancer recurrence in the pelvic area (pelvic recurrence) at 3 years. The prespecified noninferiority margin for the between-group difference in pelvic recurrence at 3 years was 4 percentage points. RESULTS: Among 700 patients who underwent randomization (350 in each group), the majority had tumors that were stage IB1 according to the 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7%), that had squamous-cell histologic features (61.7%), and that were grade 1 or 2 (59.3%). With a median follow-up time of 4.5 years, the incidence of pelvic recurrence at 3 years was 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group (an absolute difference of 0.35 percentage points; 90% confidence interval, -1.62 to 2.32). Results were similar in a per-protocol analysis. The incidence of urinary incontinence was lower in the simple hysterectomy group than in the radical hysterectomy group within 4 weeks after surgery (2.4% vs. 5.5%; P = 0.048) and beyond 4 weeks (4.7% vs. 11.0%; P = 0.003). The incidence of urinary retention in the simple hysterectomy group was also lower than that in the radical hysterectomy group within 4 weeks after surgery (0.6% vs. 11.0%; P<0.001) and beyond 4 weeks (0.6% vs. 9.9%; P<0.001). CONCLUSIONS: In patients with low-risk cervical cancer, simple hysterectomy was not inferior to radical hysterectomy with respect to the 3-year incidence of pelvic recurrence and was associated with a lower risk of urinary incontinence or retention. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov number, NCT01658930.).


Assuntos
Carcinoma de Células Escamosas , Histerectomia , Neoplasias do Colo do Útero , Feminino , Humanos , Canadá , Carcinoma de Células Escamosas/patologia , Carcinoma de Células Escamosas/cirurgia , Histerectomia/efeitos adversos , Histerectomia/métodos , Linfonodos/patologia , Recidiva Local de Neoplasia/epidemiologia , Estadiamento de Neoplasias , Prognóstico , Estudos Retrospectivos , Incontinência Urinária/etiologia , Retenção Urinária/etiologia , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/cirurgia
2.
J Low Genit Tract Dis ; 28(1): 48-53, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-37934148

RESUMO

OBJECTIVES: This study compared aesthetic outcome, psychosexual distress, and treatment satisfaction between women receiving surgical treatment or medical treatment with imiquimod for vulvar high-grade squamous intraepithelial lesion. MATERIALS AND METHODS: This is an extended analysis of the multicenter, randomized noninferiority trial "topical imiquimod versus surgery for vulvar intraepithelial neoplasia." Patients were randomized to primary topical treatment or surgery and stratified by unifocal or multifocal disease. Digital photos of vulvar appearance were subsequently assessed for aesthetic outcome by 3 investigators blinded to group allocation. Psychosexual distress and treatment satisfaction were assessed with the Cervical Dysplasia Distress Questionnaire, the Sexual Activity Questionnaire, and the Client Satisfaction Questionnaire at baseline and follow-up. RESULTS: One hundred ten patients aged between 19 and 82 years were enrolled. Per-protocol analysis showed complete clinical response in 80% (37/46) using imiquimod, compared with 79% (41/52) after one surgical intervention. Photodocumentation at baseline and 6-month follow-up was available for 84 of these patients (44 imiquimod, 40 surgery). Blinded reviewer assessments of lesion size and lesion severity showed improvement from baseline to follow-up, with no differences between treatment groups. Sexual pleasure, discomfort, and distress remained stable from baseline to follow-up in both groups. CONCLUSIONS: Good aesthetic outcome of vulvar high-grade squamous intraepithelial lesion treatment can be achieved with imiquimod and surgery, consisting of ablation or local excision. Treatment satisfaction and stable psychosexual health may not be dependent on chosen treatment modality, but rather on counseling in accordance with patients' preferences.


Assuntos
Antineoplásicos , Carcinoma in Situ , Neoplasias Cutâneas , Displasia do Colo do Útero , Neoplasias Vulvares , Humanos , Feminino , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Imiquimode/uso terapêutico , Antineoplásicos/uso terapêutico , Aminoquinolinas , Neoplasias Vulvares/patologia , Displasia do Colo do Útero/cirurgia , Carcinoma in Situ/patologia , Resultado do Tratamento
3.
J Am Coll Surg ; 237(5): 796-797, 2023 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-37551909
4.
Radiother Oncol ; 184: 109682, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37336614

RESUMO

In 2018, the European Society of Gynecological Oncology (ESGO) jointly with the European Society for Radiotherapy and Oncology (ESTRO) and the European Society of Pathology (ESP) published evidence-based guidelines for the management of patients with cervical cancer. Given the large body of new evidence addressing the management of cervical cancer, the three sister societies jointly decided to update these evidence-based guidelines. The update includes new topics to provide comprehensive guidelines on all relevant issues of diagnosis and treatment in cervical cancer. To serve on the expert panel (27 experts across Europe) ESGO/ESTRO/ESP nominated practicing clinicians who are involved in managing patients with cervical cancer and have demonstrated leadership through their expertise in clinical care and research, national and international engagement, profile, and dedication to the topics addressed. To ensure the statements were evidence based, new data identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Before publication, the guidelines were reviewed by 155 independent international practitioners in cancer care delivery and patient representatives. These updated guidelines are comprehensive and cover staging, management, follow-up, long-term survivorship, quality of life and palliative care. Management includes fertility sparing treatment, early and locally advanced cervical cancer, invasive cervical cancer diagnosed on a simple hysterectomy specimen, cervical cancer in pregnancy, rare tumors, recurrent and metastatic diseases. The management algorithms and the principles of radiotherapy and pathological evaluation are also defined.


Assuntos
Radioterapia (Especialidade) , Neoplasias do Colo do Útero , Feminino , Gravidez , Humanos , Neoplasias do Colo do Útero/terapia , Neoplasias do Colo do Útero/patologia , Qualidade de Vida , Oncologia , Europa (Continente)
5.
Geburtshilfe Frauenheilkd ; 83(2): 165-183, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37151735

RESUMO

Purpose This guideline provides recommendations for the diagnosis, treatment and follow-up care of 3rd and 4th degree perineal tears which occur during vaginal birth. The aim is to improve the management of 3rd and 4th degree perineal tears and reduce the immediate and long-term damage. The guideline is intended for midwives, obstetricians and physicians involved in caring for high-grade perineal tears. Methods A selective search of the literature was carried out. Consensus about the recommendations and statements was achieved as part of a structured process during a consensus conference with neutral moderation. Recommendations After every vaginal birth, a careful inspection and/or palpation by the obstetrician and/or the midwife must be carried out to exclude a 3rd or 4th degree perineal tear. Vaginal and anorectal palpation is essential to assess the extent of birth trauma. The surgical team must also include a specialist physician with the appropriate expertise (preferably an obstetrician or a gynecologist or a specialist for coloproctology) who must be on call. In exceptional cases, treatment may also be delayed for up to 12 hours postpartum to ensure that a specialist is available to treat the individual layers affected by trauma. As neither the end-to-end technique nor the overlapping technique have been found to offer better results for the management of tears of the external anal sphincter, the surgeon must use the method with which he/she is most familiar. Creation of a bowel stoma during primary management of a perineal tear is not indicated. Daily cleaning of the area under running water is recommended, particularly after bowel movements. Cleaning may be carried out either by rinsing or alternate cold and warm water douches. Therapy should also include the postoperative use of laxatives over a period of at least 2 weeks. The patient must be informed about the impact of the injury on subsequent births as well as the possibility of anal incontinence.

6.
Virchows Arch ; 482(6): 935-966, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37145263

RESUMO

In 2018, the European Society of Gynecological Oncology (ESGO) jointly with the European Society for Radiotherapy and Oncology (ESTRO) and the European Society of Pathology (ESP) published evidence-based guidelines for the management of patients with cervical cancer. Given the large body of new evidence addressing the management of cervical cancer, the three sister societies jointly decided to update these evidence-based guidelines. The update includes new topics to provide comprehensive guidelines on all relevant issues of diagnosis and treatment in cervical cancer.To serve on the expert panel (27 experts across Europe) ESGO/ESTRO/ESP nominated practicing clinicians who are involved in managing patients with cervical cancer and have demonstrated leadership through their expertise in clinical care and research, national and international engagement, profile, and dedication to the topics addressed. To ensure the statements were evidence based, new data identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Before publication, the guidelines were reviewed by 155 independent international practitioners in cancer care delivery and patient representatives.These updated guidelines are comprehensive and cover staging, management, follow-up, long-term survivorship, quality of life and palliative care. Management includes fertility sparing treatment, early and locally advanced cervical cancer, invasive cervical cancer diagnosed on a simple hysterectomy specimen, cervical cancer in pregnancy, rare tumors, recurrent and metastatic diseases. The management algorithms and the principles of radiotherapy and pathological evaluation are also defined.


Assuntos
Neoplasias do Colo do Útero , Feminino , Gravidez , Humanos , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/terapia , Neoplasias do Colo do Útero/patologia , Qualidade de Vida , Oncologia , Europa (Continente)
7.
Int J Gynecol Cancer ; 33(5): 649-666, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-37127326

RESUMO

In 2018, the European Society of Gynecological Oncology (ESGO) jointly with the European Society for Radiotherapy and Oncology (ESTRO) and the European Society of Pathology (ESP) published evidence-based guidelines for the management of patients with cervical cancer. Given the large body of new evidence addressing the management of cervical cancer, the three sister societies jointly decided to update these evidence-based guidelines. The update includes new topics to provide comprehensive guidelines on all relevant issues of diagnosis and treatment in cervical cancer.To serve on the expert panel (27 experts across Europe) ESGO/ESTRO/ESP nominated practicing clinicians who are involved in managing patients with cervical cancer and have demonstrated leadership through their expertise in clinical care and research, national and international engagement, profile, and dedication to the topics addressed. To ensure the statements were evidence based, new data identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Before publication, the guidelines were reviewed by 155 independent international practitioners in cancer care delivery and patient representatives.These updated guidelines are comprehensive and cover staging, management, follow-up, long-term survivorship, quality of life and palliative care. Management includes fertility sparing treatment, early and locally advanced cervical cancer, invasive cervical cancer diagnosed on a simple hysterectomy specimen, cervical cancer in pregnancy, rare tumors, recurrent and metastatic diseases. The management algorithms and the principles of radiotherapy and pathological evaluation are also defined.


Assuntos
Radioterapia (Especialidade) , Neoplasias do Colo do Útero , Feminino , Gravidez , Humanos , Neoplasias do Colo do Útero/patologia , Qualidade de Vida , Oncologia , Europa (Continente)
8.
Eur J Obstet Gynecol Reprod Biol ; 285: 81-85, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37087834

RESUMO

OBJECTIVE: Enhanced recovery after surgery (ERAS) recommendations for cesarean section (ERAC), likely the most common reason for laparotomy in women, were issued in 2018-19. We examined how current perioperative management at cesarean section in Austrian hospitals aligns with ERAS recommendations. STUDY DESIGN: We surveyed the 21 largest public obstetric units in Austria for alignment with 20 of the 31 strong ERAS recommendations regarding perioperative maternal care at cesarean section. We also looked at how the German-language clinical guideline for cesarean section (AWMF Guideline Sectio caesarea) aligns with ERAS recommendations. RESULTS: The 21 obstetric units cared for about 51% of all births in Austria in 2019. Cesarean section rates ranged from 17.7% to 50.4%. All 21 units implemented the five strong recommendations regarding patient information and counselling, regional anesthesia, euvolemia and multimodal analgesia. The least implemented strong recommendation was the one for the use of pneumatic compression stockings to prevent thromboembolic disease (0/21 units). Overall, all 21 units implemented ≥11 and 13 (62%) implemented ≥15 (≥75%) of the 20 strong recommendations; no unit implemented all 20 strong recommendations. There were no differences in the implementation of strong recommendations according to hospital volume. CONCLUSIONS: Even in the absence of formal adoption of ERAS program for cesarean section many perioperative ERAS recommendations are already implemented in Austria. The least implemented recommendations were the use of pneumatic compression stockings (0 of 21 units) and immediate catheter removal (4 of 21 units). Only 10 of the 20 ERAS recommendations we looked at are included in the current German-language clinical guideline for cesarean section.


Assuntos
Analgesia , Cesárea , Gravidez , Feminino , Humanos , Áustria , Assistência Perioperatória , Manejo da Dor
9.
Geburtshilfe Frauenheilkd ; 83(4): 410-436, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37034416

RESUMO

Aim This completely revised interdisciplinary S2k-guideline on the diagnosis, therapy, and follow-up care of female patients with urinary incontinence (AWMF registry number: 015-091) was published in December 2021. This guideline combines and summarizes earlier guidelines such as "Female stress urinary incontinence," "Female urge incontinence" and "Use of Ultrasonography in Urogynecological Diagnostics" for the first time. The guideline was coordinated by the German Society for Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe, DGGG) and the Working Group for Urogynecology and Plastic Pelvic Floor Reconstruction (Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V., AGUB). Methods This S2k-guideline was developed using a structured consensus process involving representative members from different medical specialties and was commissioned by the Guidelines Commission of the DGGG, OEGGG and SGGG. The guideline is based on the current version of the guideline "Urinary Incontinence in Adults" published by the European Association of Urology (EAU). Country-specific items associated with the respective healthcare systems in Germany, Austria and Switzerland were also incorporated. Recommendations The short version of this guideline consists of recommendations and statements on the surgical treatment of female patients with stress urinary incontinence and urge incontinence. Specific solutions for the diagnostic workup and treatment of uncomplicated and complicated urinary incontinence are discussed. The diagnostics and surgical treatment of iatrogenic urogenital fistula are presented.

10.
Geburtshilfe Frauenheilkd ; 83(4): 377-409, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37034417

RESUMO

Aim This completely revised interdisciplinary S2k-guideline on the diagnosis, therapy, and follow-up care of female patients with urinary incontinence (AWMF registry number: 015-091) was published in December 2021. This guideline combines and summarizes earlier guidelines such as "Female stress urinary incontinence," "Female urge incontinence" and "Use of Ultrasonography in Urogynecological Diagnostics" for the first time. The guideline was coordinated by the German Society for Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe, DGGG) and the Working Group for Urogynecology and Plastic Pelvic Floor Reconstruction (Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V., AGUB). Methods This S2k-guideline was developed using a structured consensus process involving representative members from different medical specialties and was commissioned by the Guidelines Commission of the DGGG, OEGGG and SGGG. The guideline is based on the current version of the guideline "Urinary Incontinence in Adults" published by the European Association of Urology (EAU). Country-specific items associated with the respective healthcare systems in Germany, Austria and Switzerland were also incorporated. Recommendations The short version of this guideline consists of recommendations and statements on the epidemiology, etiology, classification, symptoms, diagnostics, and treatment of female patients with urinary incontinence. Specific solutions for the diagnostic workup and appropriate conservative and medical therapies for uncomplicated and complication urinary incontinence are discussed.

11.
Int J Transgend Health ; 24(1): 108-112, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36713147

RESUMO

Background: Colpectomy is a frequent part of gender-affirming surgery in transgender men. Urologic complications with these procedures can complicate and delay further management. Aim: We reviewed the rate of postoperative voiding dysfunction after colpectomy with urethral lengthening in transgender men. Methods: We reviewed postoperative voiding in 47 transgender men (age, 19-50 years) who underwent colpectomy with urethral lengthening. Thirty-eight patients (81%) had undergone hysterectomy (36 total, 2 subtotal/supracervical) previously and 11 (23%) underwent concomitant hysterectomy or removal of the residual cervix (4 abdominal, 6 laparoscopic, 1 transvaginal). Colpectomy was done transvaginally by opening and developing laterally the vesicovaginal and rectovaginal spaces and then transecting the lateral vaginal attachments with bipolar vessel sealing. Urethral lengthening with an anterior vaginal flap was performed in the same procedure as colpectomy. A transurethral catheter was left in situ for 14 days postoperatively. Voiding dysfunction was defined as failure of spontaneous micturition after removal of the catheter at 14 days. Results: 40/47 (85%) patients were able to void after catheter removal, 7 (15%) were not. Voiding dysfunction occurred in 3/11 (27%) patients undergoing concomitant hysterectomy or removal of a residual cervix and in 4/36 patients (11%) status post total hysterectomy. Voiding dysfunction persisted for a median of 3 months (2 days - 46 months). Conclusions: In this series voiding dysfunction developed in 15% of transgender men undergoing colpectomy with urethral lengthening and appeared to be more common in patients undergoing concomitant hysterectomy or removal of a residual cervix than in those status post hysterectomy. Patients should be counseled accordingly.

12.
Maturitas ; 167: 1-7, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36279690

RESUMO

BACKGROUND: Urogenital atrophy affects >50 % of women after breast cancer (BC) and there is reluctance to use local estrogen for this group. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have been shown to produce symptom relief in women with BC and urogenital atrophy, but have not been tested against each other. The aim of this study was to compare these nonhormonal modalities in women with urogenital atrophy after BC in a randomized fashion. STUDY DESIGN: We randomly assigned 43 women (aged 49-58 years, mean age 54 years) with urogenital atrophy and a history of BC to receive intravaginal laser therapy (2 courses within 1 month) or hyaluronic acid suppositories (3 times/week continuously for three months). The primary endpoint was score on the Vaginal Health Index after 3 months. Secondary endpoints were subjective bother on a numeric rating scale for all urogenital atrophy domains, quality of life, sexual health and pelvic organ prolapse symptoms using validated questionnaires. RESULTS: Of the 43 women who participated, 22 were randomized to intravaginal laser therapy, and 21 to vaginal suppositories. At 3 months score on the Vaginal Health Index had improved significantly in both groups (p = 0.001), without a significant difference between treatment groups (p = 0.232). Significant improvement was also seen in both groups for subjective bother of urogenital atrophy, quality of life and sexual health, without significant differences between laser or hyaluronic acid therapy. CONCLUSIONS: Both intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after BC suffering from urogenital atrophy. No difference was found between treatment regimens. CLINICALTRIALS: gov identifier: NCT03816735, https://clinicaltrials.gov/ct2/show/NCT03816735.


Assuntos
Neoplasias da Mama , Terapia a Laser , Doenças Vaginais , Feminino , Humanos , Supositórios , Neoplasias da Mama/complicações , Neoplasias da Mama/radioterapia , Neoplasias da Mama/tratamento farmacológico , Ácido Hialurônico/uso terapêutico , Qualidade de Vida , Vagina/patologia , Atrofia/patologia , Lasers , Doenças Vaginais/tratamento farmacológico , Doenças Vaginais/etiologia , Administração Intravaginal
13.
Eur J Obstet Gynecol Reprod Biol ; 274: 13-18, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35561565

RESUMO

OBJECTIVE: The prevalence of cervical intraepithelial neoplasia (CIN) in pregnancy is about 1%. The aim of this study was to analyze the regression, persistence and progression rates of cervical dysplasia in pregnancy and the impact of delivery mode. STUDY DESIGN: In this retrospective study, data from pregnant patients with abnormal cytology findings, who presented to a colposcopic outpatient clinic of a university hospital within the last 10 years, were analyzed. Information on cytology, histology and Human Papillomavirus (HPV) status during pregnancy and postpartum and mode of delivery was collected. RESULTS: 219 women, who were assessed with cytology and /or biopsy antepartum and postpartum between January 2010 and July 2020, were included in the study. Antepartum patients presented with low grade squamous intraepithelial lesions (LSIL) in 37% and high grade squamous intraepithelial lesions (HSIL) in 53%. During pregnancy biopsy was performed in 78 patients (36%). Postpartum evaluation revealed an overall regression rate of 39%. Persistence rates were especially high in the HSIL group with 70 %. HSIL regressed in 28 %. Progression to invasive disease was rare and seen in two patients postpartum only. 141 women delivered vaginally (VD) and 51 received a cesarean section (CS). Regression rates were similar: 36 % and 47 %. There was no significant difference in progression or persistence rates. CONCLUSION: Our study demonstrates that mode of delivery does not influence the course of SIL. SIL show high rates of regression and persistence, progression to invasive disease is rare.


Assuntos
Infecções por Papillomavirus , Complicações Neoplásicas na Gravidez , Displasia do Colo do Útero , Neoplasias do Colo do Útero , Cesárea , Colposcopia , Feminino , Humanos , Infecções por Papillomavirus/patologia , Gravidez , Complicações Neoplásicas na Gravidez/epidemiologia , Complicações Neoplásicas na Gravidez/patologia , Estudos Retrospectivos , Displasia do Colo do Útero/epidemiologia , Displasia do Colo do Útero/patologia , Neoplasias do Colo do Útero/epidemiologia , Neoplasias do Colo do Útero/patologia , Esfregaço Vaginal
14.
Lancet ; 399(10337): 1790-1798, 2022 05 07.
Artigo em Inglês | MEDLINE | ID: mdl-35483400

RESUMO

BACKGROUND: The optimal management of vulvar high-grade squamous intraepithelial lesions (vHSILs) is challenging. Surgery is the standard treatment, but recurrences are observed in half of patients. Medical treatment with imiquimod is an effective alternative, but the two modalities have not been compared in a randomised trial. The aim of this study was to compare the clinical effectiveness, histological response, human papillomavirus (HPV) clearance, acceptance, and psychosexual morbidity of primary imiquimod treatment versus surgical treatment in women with vHSIL. METHODS: This study was a multicentre, randomised, phase 3, non-inferiority clinical trial done by the Austrian Gynaecological Oncology group at six hospitals in Austria. We recruited female patients aged 18-90 years with histologically confirmed vHSIL with visible unifocal or multifocal lesions. Main exclusion criteria were clinical suspicion of invasion, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, and any active treatment for vHSIL within the previous 3 months. Women with known immunodeficiency, who were pregnant, or who were lactating were excluded. Patients were randomly assigned (1:1) by block randomisation to imiquimod or surgery, and stratified by unifocal or multifocal disease. Treatment with imiquimod was self-administered in a slowly escalating dosage scheme up to three times per week for a period of 4-6 months. Surgery consisted of excision or ablation. Patients were assessed with vulvoscopy, vulvar biopsy, HPV tests, and patient-reported outcomes at baseline and after 6 months and 12 months. The primary endpoint was complete clinical response (CCR) at 6 months after local imiquimod treatment or one surgical intervention. Primary analysis was per protocol with a non-inferiority margin of 20%. This trial is registered at ClinicalTrials.gov, NCT01861535. FINDINGS: 110 patients with vHSIL (78% with unifocal vHSIL and 22% with multifocal vHSIL) were randomly assigned between June 7, 2013, and Jan 8, 2020. Clinical response to treatment could be assessed in 107 patients (54 in the imiquimod group and 53 in the surgery group), and 98 patients (46 in the imiquimod group and 52 in the surgery group) completed the study per protocol. 37 (80%) of 46 patients using imiquimod had CCR, compared with 41 (79%) of 52 patients after one surgical intervention, showing non-inferiority of the new treatment (difference in proportion -0·016, 95% CI -0·15 to -0·18; p=0·0056). Invasive disease was found in five patients at primary or secondary surgery, but not in patients with per-protocol imiquimod treatment. There was no significant difference in HPV clearance, adverse events, and treatment satisfaction between study groups. INTERPRETATION: Imiquimod is a safe, effective, and well accepted alternative to surgery for women with vHSIL and can be considered as first-line treatment. FUNDING: Austrian Science Fund and Austrian Gynaecological Oncology group.


Assuntos
Infecções por Papillomavirus , Lesões Intraepiteliais Escamosas , Neoplasias Vulvares , Feminino , Humanos , Imiquimode/uso terapêutico , Lactação , Gravidez , Neoplasias Vulvares/tratamento farmacológico , Neoplasias Vulvares/patologia , Neoplasias Vulvares/cirurgia
15.
Int Urogynecol J ; 33(9): 2357-2366, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-34870713

RESUMO

INTRODUCTION AND HYPOTHESIS: We conducted a systematic review of the effectiveness of local preemptive analgesia for postoperative pain control in women undergoing vaginal hysterectomy. METHODS: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews were searched systematically to identify eligible studies published through September 25, 2019. Only randomized controlled trials and systematic reviews addressing local preemptive analgesia compared to placebo at vaginal hysterectomy were considered. Data were extracted by two independent reviewers. Results were compared, and disagreement was resolved by discussion. Forty-seven studies met inclusion criteria for full-text review. Four RCTs, including a total of 197 patients, and two SRs were included in the review. RESULTS: Preemptive local analgesia reduced postoperative pain scores up to 6 h and postoperative opioid requirements in the first 24 h after surgery. CONCLUSION: Preemptive local analgesia at vaginal hysterectomy results in less postoperative pain and less postoperative opioid consumption.


Assuntos
Analgesia , Histerectomia Vaginal , Feminino , Humanos , Analgesia/métodos , Analgésicos Opioides/uso terapêutico , Histerectomia , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/prevenção & controle
16.
Gynecol Oncol ; 164(1): 76-84, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34763939

RESUMO

BACKGROUND: Lower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. However, the lack of standardisation of volumetric LLL assessment hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective trial that have implications for LLL assessment standardisation. METHODS: In the prospective international multicentre trial SENTIX, a group of 150 patients with stage IA1-IB2 cervical cancer treated by uterine surgery with bilateral sentinel lymph node biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery. RESULTS: Patient LVC substantially fluctuated in both positive and negative directions, which were comparable in frequency up to ±14% change. Thirty-eight patients experienced persistent LVC increase >10% classified as LLL, with nine months median time to onset. Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits. No significant correlation between LVC >10% and a patient-reported swelling was observed. CONCLUSIONS: Given that we observed comparable fluctuations of the the lower-limb volumes after surgical treatment of cervical cancer in both positive and negative direction up to ±14%, the diagnostic threshold for LLL diagnosis based on LVC should be increased to >15% LVC. The distinction of transient oedema from persistent LLL requires repeated measurements. Also, as one-third of LLL cases are diagnosed >1-year post-surgery, a sufficient follow-up duration needs to be ensured. Patient-reported swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02494063.


Assuntos
Tomada de Decisões , Linfedema/patologia , Estadiamento de Neoplasias , Neoplasias do Colo do Útero/patologia , Adulto , Europa (Continente) , Feminino , Humanos , Extremidade Inferior , Estudos Prospectivos , Biópsia de Linfonodo Sentinela , África do Sul
17.
Reprod Sci ; 28(12): 3515-3518, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34611849

RESUMO

There are few data on complications with gender affirming surgery. The aim of this study was to assess peri- and postoperative complications of laparoscopic hysterectomy and mastectomy performed in a single sitting in transgender men. Assessment of intra- and postoperative complications in a series of 65 transgender men (mean age 27, range 18-47) undergoing concomitant mastectomy and laparoscopic hysterectomy with salpingo-oophorectomy. Mean operating time was 292 ± 47 min. Thirty-four (52%) patients experienced complications: 28 (41%) DINDO grade I, 0 DINDO grade 2, 6 (11%) DINDO grade III. The six grade 3 complications consisted of 5 hematomas requiring evacuation after mastectomy and 2 vaginal tears requiring transvaginal repair. Three patients were readmitted within 30 days, all for postoperative bleeding/hematoma. In transgender men, performing laparoscopic hysterectomy and mastectomy at a single sitting has a modest rate of perioperative complications, and may improve resource utilization.


Assuntos
Histerectomia/métodos , Laparoscopia/métodos , Mastectomia/métodos , Complicações Pós-Operatórias/diagnóstico , Salpingo-Ooforectomia/métodos , Pessoas Transgênero , Adulto , Estudos de Coortes , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Feminino , Seguimentos , Humanos , Histerectomia/efeitos adversos , Laparoscopia/efeitos adversos , Masculino , Mastectomia/efeitos adversos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Salpingo-Ooforectomia/efeitos adversos
18.
Sex Med ; 9(6): 100432, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34551383

RESUMO

INTRODUCTION: Treatment for vulvodynia is challenging and a multidisciplinary approach is recommended. AIM: To examine the effectiveness, safety and treatment satisfaction of vulvovaginal microablative laser treatment for vulvodynia. METHODS: Case study of women who received laser treatment as part of a multidisciplinary treatment program for vulvodynia. Subjective improvement was compared to a retrospective cohort of women treated for vulvodynia without LASER therapy. LASER treatment was offered to women with vulvodynia presenting to a gynecologic pain clinic of a tertiary university hospital. LASER treatments were performed with a microablative 2,940 nm Er:YAG LASER and potentially repeated after 1 month. MAIN OUTCOME MEASURES: Change in local vulvar pain was assessed with cotton-swab tests and rated on a numeric rating scale (NRS). Treatment discomfort and short-term adverse events were recorded. The Freiburg Index of Patient Satisfaction was used to assess treatment satisfaction. Subjective symptom improvement was assessed with the Patient Global Impression of Improvement questionnaire. RESULTS: 35 women received at least 1 laser treatment, with overall mild treatment adverse effects (mean pain NRS 2.4 ± 1.9) and good treatment satisfaction (mean total score of 27.6 ±5.1; potential range 8-32). One month after last LASER treatment the pain NRS on vulvar cotton swab test improved from 6.1 ± 2.6 at baseline to 3.1 ± 2.6 (P < .001), and 74% of women (n = 26) reported symptom improvement. At 9-12 months follow-up 66% reported ongoing symptom improvement, with no significant difference to the control group of 32 women. CONCLUSION: Microablative Er:YAG vulvovaginal LASER therapy appears safe and well accepted among vulvodynia patients, but there was no significant difference in symptom improvement compared to a control group. Trutnovsky G, Bliem B, Greimel E, et al. Microablative Erbium: YAG Laser Therapy for Vulvodynia - A Report on Efficacy, Safety, and Treatment Satisfaction. Sex Med 2021;9:100432.

19.
J Clin Oncol ; 39(32): 3623-3632, 2021 11 10.
Artigo em Inglês | MEDLINE | ID: mdl-34432481

RESUMO

PURPOSE: The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS: GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS: From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION: Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.


Assuntos
Excisão de Linfonodo , Doses de Radiação , Linfonodo Sentinela/efeitos da radiação , Linfonodo Sentinela/cirurgia , Neoplasias Vulvares/terapia , Idoso , Feminino , Humanos , Excisão de Linfonodo/efeitos adversos , Excisão de Linfonodo/mortalidade , Metástase Linfática , Pessoa de Meia-Idade , Micrometástase de Neoplasia , Estadiamento de Neoplasias , Estudos Prospectivos , Linfonodo Sentinela/patologia , Fatores de Tempo , Resultado do Tratamento , Neoplasias Vulvares/mortalidade , Neoplasias Vulvares/patologia
20.
Geburtshilfe Frauenheilkd ; 81(4): 447-468, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33867563

RESUMO

Purpose Positioning injuries are relatively common, forensically highly relevant complications of gynecologic surgery. The aim of this official AWMF S2k-guideline is to provide statements and recommendations on how to prevent positioning injuries using the currently available literature. The literature was evaluated by an interdisciplinary group of experts from professional medical societies. The consensus on recommendations and statements was achieved in a structured consensus process. Method The current guideline is based on the expired S1-guideline, which was updated by a systematic search of the literature and a review of relevant publications issued between February 2014 and March 2019. Statements were compiled and voted on by a panel of experts. Recommendations The guideline provides general and specific recommendations on the prevention, diagnosis and treatment of positioning injuries.

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