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BACKGROUND: Locoregional recurrence is a critical factor in the prognosis of sinonasal malignancies. Due to the rarity of these tumours, as well as the heterogeneity of histologies and anatomical subsites, there is little evidence regarding the rate and location of regional metastases in sinonasal malignancies. Elective regional lymph node dissection in the therapy of sinonasal malignancies has become controversial. On the one hand, elective regional lymph node dissection is considered to be an overtreatment in the cN0 cases. On the other hand, undetected occult lymphatic metastases are associated with a poor prognosis. In this study, we discuss the role of sentinel lymph node biopsy as a minimally invasive procedure in the treatment of sinonasal malignancies based on our two years of practical experience and the currently available data. RESULTS: This is a descriptive, monocentric, retrospective study, including 20 cases of cN0 malignant sinonasal neoplasm, that underwent a surgical therapy between 2020 and 2022. The following aspects were investigated: tumour entity, localisation of the primary tumour, tumoral stage, localisation of the sentinel lymph nodes, and postoperative complications. Squamous cell carcinoma was the most frequently diagnosed tumour entity (50%), followed by adenocarcinoma (20%) and malignant melanoma (15%), adenoid cystic carcinoma and mucoepidermoid carcinoma. Sentinel lymph nodes were most frequently found in the ipsilateral neck region I (45%), followed by the ipsilateral neck region II (40%). In all cases, the removed lymph nodes were free of malignancy. There were no postoperative complications due to lymph node biopsy. There were no recurrences during the study period. CONCLUSION: Sentinel node biopsy could add more safety to the management of cN0 sinonasal malignancies due to its low morbidity. Whether SNB could provide an alternative to elective neck dissection in the management of SNM should be investigated in further studies.
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Biopsia del Ganglio Linfático Centinela , Neoplasias Cutáneas , Humanos , Biopsia del Ganglio Linfático Centinela/métodos , Estudios Retrospectivos , Recurrencia Local de Neoplasia/cirugía , Neoplasias Cutáneas/patología , Metástasis LinfáticaRESUMEN
Heterotopic pregnancy is an extremely rare condition in which an intrauterine and an extrauterine pregnancy co-exist. In spontaneous conceptions, heterotopic pregnancy occurs in only 1/30 000 pregnancies. The treatment of heterotopic pregnancy must be as minimally invasive as possible to preserve the development of the intrauterine pregnancy. Superfetation, defined as the coexistence of 2 or more foetuses of different gestational ages, remains particularly exceptional and poorly explained (second ovulation? embryonic diapause?). Here, we present an extremely rare case of a spontaneous heterotopic evolutive pregnancy with superfetation, consisting of an embryo in the pouch of Douglas estimated at 8 + 1 weeks of gestation (WG) and a progressive intrauterine pregnancy estimated at 5 + 4 WG. We treated the extrauterine pregnancy with an intra-cardiac injection of potassium chloride echo-guided via the vaginal route, and the patient then underwent exploratory laparoscopy 9 days later and lavage and aspiration of the abdominal heterotopic pregnancy due to pain and biological inflammatory syndrome probably caused by pelvic mass syndrome and peritoneal irritation from the foetal necrosis. She has not yet given birth and is currently at 36 WG.
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Embarazo Abdominal , Embarazo Heterotópico , Superfetación , Embarazo , Femenino , Humanos , Embarazo Heterotópico/diagnóstico por imagen , Embarazo Heterotópico/cirugía , Edad Gestacional , Embarazo Abdominal/diagnóstico , Embarazo Abdominal/cirugía , FertilizaciónRESUMEN
Background: Management of endometriosis should be based on the best available evidence. The pyramid of evidence reflects unbiased observations analysed with traditional statistics. Evidence-based medicine (EBM) is the clinical interpretation of these data by experts. Unfortunately, traditional statistical inference can refute but cannot confirm a hypothesis and clinical experience is considered a personal opinion. Objectives: A proof of concept to document clinical experience by considering each diagnosis and treatment as an experiment with an outcome, which is used to update subsequent management. Materials and Methods: Experience and knowledge-based questions were answered on a 0 to 10 visual analogue scale (VAS) by surgery-oriented clinicians with experience of > 50 surgeries for endometriosis. Results: The answers reflect the collective clinical experience of managing >10.000 women with endometriosis. Experience-based management was overall comparable as approved by >75% of answers rated ≥ 8/10 VAS. Knowledge-based management was more variable, reflecting debated issues and differences between experts and non-experts. Conclusions: The collective experience-based management of those with endometriosis is similar for surgery-oriented clinicians. Results do not conflict with EBM and are a Bayesian prior, to be confirmed, refuted or updated by further observations. What is new?: Collective experience-based management can be measured and is more than a personal opinion. This might extend EBM trial results to the entire population and add data difficult to obtain in RCTs, such as many aspects of surgery.
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BACKGROUND: Vesicovaginal fistulas (VVF) are an unusual problem that may significantly affect a patient's quality of life. The main causes for this condition are labour complications (mostly in developing countries) and pelvic surgeries (in industrialised countries). Treatment may be conservative or surgical. Regarding surgical treatment, there is still debate about the best approach and surgical technique. OBJECTIVE: To demonstrate a correction of a VVF guided by cystoscopy using intravesical laparoscopic instruments. METHODS: Case report and surgical video of a recurrent VVF treated with a hybrid technique involving direct transvesical insertion of 3 mm laparoscopic trocars and instruments guided by cystoscopy. As far as we know, although there are some reported techniques that use a combination of transvesical laparoscopic instruments and cystoscopy, this is the least invasive and most ergonomic technique described. RESULTS: Two years after surgery, the patient remains asymptomatic and with no fistula recurrence. CONCLUSION: The transvesical approach guided by cystoscopy seems to be an effective, safe and ergonomic minimally invasive procedure for VVF repair.
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BACKGROUND: Recurrent spontaneous epistaxis is the most common clinical manifestation and the most debilitating symptom in hereditary haemorrhagic telangiectasia (HHT) patients. To this date, there exist only a classification of HHT patients by different genetic mutations. There is no standard classification for the mucocutaneous endonasal manifestations of HHT. The aim of the present study was to document the variety of endonasal HHT lesions using digital microscopy and to propose a clinical classification. METHODS: We recorded the endonasal HHT lesions of 28 patients using a digital microscope. We reconstructed the 3D images und videos recorded by digital microscope afterwards and classified the endonasal lesions of HHT in two classes: Grade A, presence of only flat telangiectasias in the mucosa level and Grade B, (additional) presence of raised berry or wart-like telangiectasia spots. We investigated also Haemoglobin level by routine laboratory procedures, plasma VEGF level by ELISA, Severity of epistaxis by epistaxis severity score (ESS) and quality of life by a linear visual analogue scale (VAS). RESULTS: We found a higher quality of life and a lower severity of epistaxis in Grade A patients in comparison to Grade B patients. No difference in plasma VEGF level and in Haemoglobin between Grad A patients and Grade B patients could be detected. Plasma VEGF levels showed no gender specific differences. It could also not be correlated to the extranasal manifestation. CONCLUSION: The classification for endonasal manifestation of HHT proposed in this study indicates severity of epistaxis und quality of life. Digital microscopy with the ability of 3D reconstruction of images presents a useful tool for such classifications. The classification of endonasal HHT lesions using digital microscopy allows to evaluate the dynamic of HHT lesions in the course of time independent of examiner. This allows also to evaluate the efficacy of the different treatment modalities by dynamic of HHT lesions. Moreover digital microscopy is very beneficial in academic teaching of rare diseases.
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Telangiectasia Hemorrágica Hereditaria , Factor A de Crecimiento Endotelial Vascular , Epistaxis/etiología , Humanos , Microscopía , Calidad de VidaRESUMEN
Treatment of locally advanced, unresectable head and neck squamous cell carcinoma (HNSCC) often yields only modest results with radiochemotherapy (RCT) as standard of care. Prognostic features related to outcome upon RCT might be highly valuable to improve treatment. Monocarboxylate transporters-1 and -4 (MCT1/MCT4) were evaluated as potential biomarkers. A cohort of HNSCC patients without signs for distant metastases was assessed eliciting 82 individuals eligible whereof 90% were diagnosed with locally advanced stage IV. Tumor specimens were stained for MCT1 and MCT4 in the cell membrane by immunohistochemistry. Obtained data were evaluated with respect to overall (OS) and progression-free survival (PFS). Protein expression of MCT1 and MCT4 in cell membrane was detected in 16% and 85% of the tumors, respectively. Expression of both transporters was not statistically different according to the human papilloma virus (HPV) status. Positive staining for MCT1 (n = 13, negative in n = 69) strongly worsened PFS with a hazard ratio (HR) of 3.1 (95%-confidence interval 1.6-5.7, p < 0.001). OS was likewise affected with a HR of 3.8 (2.0-7.3, p < 0.001). Multivariable Cox regression confirmed these findings. We propose MCT1 as a promising biomarker in HNSCC treated by primary RCT.
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Biomarcadores de Tumor/metabolismo , Neoplasias de Cabeza y Cuello/metabolismo , Neoplasias de Cabeza y Cuello/terapia , Transportadores de Ácidos Monocarboxílicos/metabolismo , Carcinoma de Células Escamosas de Cabeza y Cuello/metabolismo , Carcinoma de Células Escamosas de Cabeza y Cuello/terapia , Simportadores/metabolismo , Adulto , Anciano , Anciano de 80 o más Años , Quimioradioterapia , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis de Supervivencia , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: From spring 2020, SARS-CoV2 began to spread worldwide, with what is now known as the first wave of the pandemic, starting in March 2020. This resulted in restructuring and shift of resources at many hospitals. The aim of our work was to detect the effects of the pandemic on the german Oto-Rhino-Laryngology (ORL) university hospitals in terms of research, student teaching and further specialist training. MATERIAL AND METHODS: The chairmen of the 39 ORL university hospitals in Germany were asked about the effects of the pandemic on research, student teaching and ORL specialist training (residency) in the period from March to April 2020 using a structured online survey. RESULTS: All 39 chairmen took part in the survey. Of these, 74.4% (29/39) stated that their research activities had deteriorated as a result of the pandemic. In 61.5% (24/39) pandemic-related research issues were addressed. All hospitals reported a restriction for in-house teaching and 97.5% (38/39) introduced new digital teaching methods. During the observation period, 74.4% of the chairmen did not see ORL specialist training (residency)at risk. CONCLUSION: Our results provide an insight into the heterogeneous effects of the pandemic. The fast processing of pandemic-related research topics and the introduction of innovative digital concepts for student teaching impressively demonstrates the great innovative potential and the ability of the ORL university hospitals to react quickly in order to maintain their tasks in research, student teaching and ORL specialist training in the best possible way even during the pandemic.
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COVID-19 , Otolaringología , Alemania/epidemiología , Hospitales Universitarios , Humanos , Pandemias , SARS-CoV-2 , Estudiantes , EnseñanzaRESUMEN
OBJECTIVE: The aim of this study was to assess incidence, causes and consequences of equipment failures in a high volume, advanced endoscopic surgery department. METHODS: This is a prospectical observational single centre study between April and July of 2019 in the Gynecological surgery department of the Estaing University Hospital of Clermont-Ferrand, France. During the study period, 171 laparoscopies were observed. Data were collected real time by three supernumerary observers. RESULTS: In total, 66 (38.6%) laparoscopies were complicated by equipment failures. The bipolar cable and forceps accounted for 31% of the total amount of malfunctions in laparoscopy. Causes of malfunctions were in 45% due to the instrument per se and in 43% due to the incorrect combination of elements. Less commonly, the equipment was not available or a mismatched was reported. The total length of the surgery increased by 1.35% due to the malfunctions. Human error was identified in 50% of cases. No morbility, neither mortality was reported in this series; however we observed 34 malfunctions that could have led to serious consequences for the patients and 3 incidents induced a real consequence on the operation workflow. CONCLUSIONS: Equipment failure is a common event in endoscopy. On the opposite, time wasted for the malfunctions is low in laparoscopy, as it only accounts for 1.35% of the overall surgical time. Human decisions contributed to malfunctions in almost half of cases. This alarming finding may advise for intensification in training on instruments of the whole surgical team.
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Laparoscopía , Falla de Equipo , Femenino , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Humanos , Laparoscopía/efectos adversos , Tempo Operativo , Instrumentos Quirúrgicos/efectos adversosRESUMEN
A major research area in Computer Assisted Intervention (CAI) is to aid laparoscopic surgery teams with Augmented Reality (AR) guidance. This involves registering data from other modalities such as MR and fusing it with the laparoscopic video in real-time, to reveal the location of hidden critical structures. We present the first system for AR guided laparoscopic surgery of the uterus. This works with pre-operative MR or CT data and monocular laparoscopes, without requiring any additional interventional hardware such as optical trackers. We present novel and robust solutions to two main sub-problems: the initial registration, which is solved using a short exploratory video, and update registration, which is solved with real-time tracking-by-detection. These problems are challenging for the uterus because it is a weakly-textured, highly mobile organ that moves independently of surrounding structures. In the broader context, our system is the first that has successfully performed markerless real-time registration and AR of a mobile human organ with monocular laparoscopes in the OR.
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Realidad Aumentada , Laparoscopía , Cirugía Asistida por Computador , Femenino , Humanos , Útero/diagnóstico por imagen , Útero/cirugíaRESUMEN
INTRODUCTION: Since December 2019, the SARS-CoV-2 virus has been rapidly spreading worldwide. In Germany, an exponential increase in the number of infections was registered at the beginning of March 2020 and led to a call of the Ministry of Health to create more capacity for intensive medical treatment in hospitals. The aim of the present study was to determine the effects of the SARS-CoV-2 pandemic on Oto-Rhino-Laryngology (ORL) university hospitals regarding patient care. MATERIALS AND METHODS: An online survey was sent out to all chairmen of the 39 ORL university hospitals in Germany. The answers to the questions referred to the defined period from March 15th to April 15th 2020 and were carried out using the online survey tool "SurveyMonkey". 87 questions focused on general information, health care, and structural effects in the respective institution. RESULTS: All chairmen of the 39 university hospitals in Germany participated in the survey. The collected data prove the considerable impact on organizational, structural and medical aspects of patient care. For example, the surveyed clinics reported a decrease in outpatient cases by 73.8â% to 26.2â±â14.2â% and in surgical treatments by 65.9â% to 34.1â±â13.9â%. In contrast, emergency treatment remained unchanged or even increased in 80â% of the facilities and surgical treatment of emergency patients remained unchanged or even increased in more than 90â%. Emergency outpatient and surgical treatment of patients was provided throughout the pandemic in all facilities. In total, about 35â000 outpatients and about 12â000 surgical cases were postponed. As a result of the acute structural changes, the potential danger of falling below current treatment standards was seen in individual areas of patient care. DISCUSSION: The assessment of the impact of the SARS-CoV-2 pandemic is heterogeneous. The majority of the chairmen are critically aware of the risk of falling below current medical treatment standards or guidelines. In the phase of an exponential increase in the number of infections, significant changes in treatment processes had to be accepted for understandable reasons. However, with the currently significantly reduced number of infections, falling below treatment standards and guidelines should not be allowed to remain constant and tolerated. SUMMARY: This study shows a differentiated picture with regard to the effects of the SARS-CoV-2 pandemic on outpatient, inpatient and operative patient care at the ORL university hospitals in Germany and illustrates the importance of these institutions for ensuring patient care during this critical phase.
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Infecciones por Coronavirus , Otolaringología , Pandemias , Neumonía Viral , Síndrome Respiratorio Agudo Grave/epidemiología , Síndrome Respiratorio Agudo Grave/terapia , Betacoronavirus , COVID-19 , Alemania , Hospitales Universitarios , Humanos , SARS-CoV-2Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/epidemiología , Procedimientos Quirúrgicos Ginecológicos , Neumonía Viral/epidemiología , COVID-19 , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/prevención & control , Femenino , Humanos , Laparoscopía/efectos adversos , Laparoscopía/métodos , Laparotomía/efectos adversos , Laparotomía/métodos , Laparotomía/normas , Quirófanos/organización & administración , Pandemias/prevención & control , Equipo de Protección Personal/normas , Neumonía Viral/diagnóstico , Neumonía Viral/prevención & control , Guías de Práctica Clínica como Asunto , Consulta Remota , SARS-CoV-2 , Ventilación/métodosAsunto(s)
Betacoronavirus , Infecciones por Coronavirus , Neumonía Viral , COVID-19 , Humanos , Pandemias , SARS-CoV-2RESUMEN
First-line diagnostic investigations for endometriosis are physical examination and pelvic ultrasound. The second-line investigations are: targeted pelvic examination performed by an expert clinician, transvaginal ultrasound performed by an expert physician sonographer (radiologist or gynaecologist), and pelvic MRI. Management of endometriosis is recommended when the disease has a functional impact. Recommended first-line hormonal therapies for the management of endometriosis-related pain are combined hormonal contraceptives (CHCs) or the 52mg levonorgestrel-releasing intrauterine system (IUS). There is no evidence base on which to recommend systematic preoperative hormonal therapy solely to prevent surgical complications or facilitate surgery. After surgery for endometriosis, a CHC or 52mg levonorgestrel-releasing IUS is recommended as first-line treatment when pregnancy is not desired. In the event of failure of the initial treatment, recurrence, or multiorgan involvement, a multidisciplinary team meeting is recommended, involving physicians, surgeons and other professionals. A laparoscopic approach is recommended for surgical treatment of endometriosis. HRT can be offered to postmenopausal women who have undergone surgical treatment for endometriosis. Antigonadotrophic hormonal therapy is not recommended for patients with endometriosis and infertility to increase the chances of spontaneous pregnancy, including postoperatively. Fertility preservation options must be discussed with patients undergoing surgery for ovarian endometriomas.
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Endometriosis/tratamiento farmacológico , Ginecología , Obstetricia , Guías de Práctica Clínica como Asunto , Sociedades Médicas , Endometriosis/diagnóstico , Endometriosis/cirugía , Femenino , Francia , Ginecología/normas , Humanos , Obstetricia/normas , Guías de Práctica Clínica como Asunto/normas , Sociedades Médicas/normasRESUMEN
Peritoneal adhesions remain a major public health problem despite the development of laparoscopy. The rules of microsurgery must be known and followed during any pelvic surgery, even in patients who no longer have a desire for pregnancy. Anti-adhesion products are numerous. All have interest, confirmed by anatomical studies showing a smaller extent or a lesser severity of adhesions associated with their use. No studies, however, show clinical benefit in terms of improved pain or postoperative fertility. Pneumoperitoneum parameters, humidification, and lower abdominal pressure should be optimized to limit peritoneal trauma. Peri-operative corticosteroids, whose benefit has been has been demonstrated in at least one randomized trial, should be systematically used.
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Infertilidad/prevención & control , Laparoscopía/métodos , Microcirugia/métodos , Enfermedades Peritoneales/prevención & control , Complicaciones Posoperatorias/prevención & control , Adherencias Tisulares/prevención & control , Humanos , Infertilidad/etiología , Laparoscopía/efectos adversos , Microcirugia/efectos adversos , Enfermedades Peritoneales/etiología , Complicaciones Posoperatorias/etiología , Adherencias Tisulares/etiologíaAsunto(s)
Endometriosis , Guías de Práctica Clínica como Asunto , Femenino , Francia , Humanos , Sociedades MédicasRESUMEN
In this chapter we have examined the possibilities of screening endometriosis, both in the general population as well as in the target population. We then proposed decision trees, for primary and secondary care. Currently, there is not enough data in the literature to develop or organize a screening test for endometriosis. Screening for endometriosis is not recommended in the general population (level A). There is also no evidence to support systematic screening in a population with genetic risk factors (endometriosis in a relative), or with other clinical risk factors (increased menstrual volume, short cycles, early menarche) (level A). However, it is possible to propose a decision tree for the management of chronic pelvic pain symptoms (dysmenorrhea, dyspareunia, non-menstrual pelvic pain). The search for symptoms suggestive of endometriosis (intense dysmenorrhea [visual analogue scale >7/10, frequent abstention, resistance to level 1 analgesics], infertility) should be systematic. The search for localizing symptoms of deep endometriosis (deep dyspareunia, cyclic defecation pain, cyclic urinary signs) enables to orient the patient to second line evaluation. We propose a decision tree for second and third line evaluations, according to the suspicion and/or the discovery of deep lesions with specific locations, or the suspicion of superficial lesions.
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Técnicas de Apoyo para la Decisión , Endometriosis/diagnóstico , Dispareunia/etiología , Femenino , Humanos , Dolor Pélvico/etiologíaRESUMEN
The article presents French guidelines for surgical management of endometriosis. Surgical treatment is recommended for mild to moderate endometriosis, as it decreases pelvic painful complaints and increases the likelihood of postoperative conception in infertile patients (A). Surgery may be proposed in symptomatic patients with ovarian endometriomas which diameter exceeds 20mm. Cystectomy allows for better postoperative pregnancy rates when compared to ablation using bipolar current, as well as for lower recurrences rates when compared to ablation using bipolar current or CO2 laser. Ablation of ovarian endometriomas using bipolar current is not recommended (B). Surgery may be employed in patients with deep endometriosis infiltrating the colon and the rectum, with good impact on painful complaints and postoperative conception. In these patients, laparoscopic route increases the likelihood of postoperative spontaneous conception when compared to open route. When compared to conservative rectal procedures (shaving or disc excision), segmental colorectal resection increases the risk of postoperative stenosis, requiring additional endoscopic or surgical procedures. In large deep endometriosis infiltrating the rectum (>20mm length of bowel infiltration), conservative rectal procedures do not improve postoperative digestive function when compared to segmental resection. In patients with bowel anastomosis, placing anti-adhesion agents on contact with bowel suture is not recommended, due to higher risk of bowel fistula (C). Various other recommendations are proposed in the text, however, they are based on studies with low level of evidence.
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Endometriosis/cirugía , Adulto , Enfermedades del Colon/etiología , Enfermedades del Colon/cirugía , Cistectomía , Endometriosis/complicaciones , Femenino , Humanos , Histerectomía , Laparoscopía , Enfermedades del Recto/etiología , Enfermedades del Recto/cirugía , Enfermedades Urológicas/etiología , Enfermedades Urológicas/cirugíaRESUMEN
According to some studies, extragenital endometriosis represents 5% of the localisations. Its prevalence seems to be underestimated. The extra pelvic localisation can make the diagnosis more difficult. Nevertheless, the recurrent and catamenial symptomatology can evoke this pathology. Surgery seems to be the unique efficient treatment for parietal lesions. Pain linked to nervous lesions (peripheric and sacral roots) seems to be underestimated and difficult to diagnose because of various localisations. Neurolysis seems to have encouraging results. Diaphragmatic lesions are often discovered either incidentally during laparoscopy, or by pulmonary symptomatology as recurrent catamenial pneumothorax or cyclic thoracic pain. Surgical treatment seems as well to be efficient.
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Abdomen/cirugía , Diafragma/cirugía , Endometriosis/terapia , Enfermedades del Sistema Nervioso Periférico/terapia , Enfermedades Torácicas/cirugía , Endometriosis/complicaciones , Endometriosis/diagnóstico , Femenino , Humanos , Laparoscopía , Enfermedades del Sistema Nervioso Periférico/etiología , Enfermedades Torácicas/etiologíaRESUMEN
Minimal and mild endometriosis (stage 1 and 2 AFSR) can lead to chronic pelvic pain and infertility but can also exist in asymptomatic patients. The prevalence of asymptomatic patients with minimal and mild endometriosis is not clear but typical endometriosis lesions are found in about 5 to 10% of asymptomatic women and more than 50% of painful and/or infertile women. Laparoscopic treatment of minimal and mild endometriotic lesions is justified in case of pelvic pain because their destruction decrease significatively the pain compared with diagnostic laparoscopy alone. In this context, ablation and excision give identical results in terms of pain reduction. Moreover, literature shows no interest in uterine nerve ablation in case of dysmenorrhea due to minimal and mild endometriosis. Then, it is recommended to treat these lesions during a laparoscopy realised as part of pelvic pain. On the other hand, it is not recommended to treat asymptomatic patients. With regard to treatment of minimal and mild endometriosis in infertile patients, only two studies can be selected and both show that laparoscopy with excision or ablation and ablation of adhesions is superior to diagnostic laparoscopy alone in terms of pregnancy rate. However, it is not recommended to treat these lesions when they are asymptomatic because there is no evidence that they can progress with symptomatic disease. There is no study assessing the interest to treat these lesions when they are found fortuitously. Adhesion barrier utilisation permits to reduce post-operative adhesions, however literature failed to demonstrate the clinical profit in terms of reduction of the risk of pain or infertility.