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OBJECTIVES: to propose guidelines for the management of complications of prosthetic mid-urethral tape surgery for stress urinary incontinence in women. METHODS: These guidelines are based on an exhaustive literature review on retropubic and trans-obturator mid-urethral tape complications. The expert panel rated the level of evidence of each study, summarized literature for the treatment of each complication, and proposed guidelines. RESULTS: Management of these complications is complex and the first treatment is crucial to offer the best functional result to the patient. We propose a standardized approach and guidelines for the management of complications to help physicians to early identify a surgical complication, offer adequate treatment for each complication and provide clear and appropriate information to patients. We detailed management of intraoperative complications: bladder, urethral, vaginal, visceral and vascular injury; short term post-operative complications: bleeding/hematoma, voiding dysfunction, pain, infection; and long-term post-operative complications: chronic voiding dysfunction, de novo overactive bladder syndrome, chronic pain, dyspareunia, vaginal, bladder and urethral tape erosion. CONCLUSION: These guidelines may help physicians to improve management of prosthetic mid-urethral sling complications that may occur following stress urinary incontinence surgery.
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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: In France, 62,000 hysterectomies are performed per year, 70% of which are benign. The choice of approach (laparotomy, laparoscopy or vaginal route) is particularly important in the case of large uterus (> 280g) which are associated with a higher risk of complications. The current data are not sufficient to favour one or other approach. A new medical device, the vNOTES (Natural Vaginal Orifice Transluminal Endoscopy System), offers the advantage of both laparoscopic and vaginal route for pelvic surgery. Objectives: To demonstrate the superiority in terms of intraoperative and postoperative complications of the use of a natural orifice transluminal endoscopic hysterectomy system (vNOTES) versus laparoscopic hysterectomy for benign pathologies on estimated large volume uteri (>280g). Materials and Methods: A randomised, double-blind, superiority trial will be performed at five hospital centres. Women with benign uterine pathology requiring hysterectomy and with a large uterus (> 280g) will be randomised to receive either laparoscopic or vNOTES hysterectomy. Main outcome measures: The primary outcome will be the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Secondary outcomes will be conversion during surgery, duration of surgery and hospitalisation, postoperative pain, postoperative complications, resumption of sexual life and satisfaction with the surgical team. Results: 248 women will be randomised. Conclusion: This trial will provide a better understanding of the approach to large uteri optimise the care of these thousands of women undergoing hysterectomy. What's new?: This trial will evaluate the vNotes for large uteri.
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Stress urinary incontinence is common in adult women. The use of introital or trans-labial ultrasound can help the surgeon (urologist or gynecologist) to better assess the type of incontinence the patient presents in order to guide him in the management of the patient. Often, surgical treatment with a mid-urethral sling (MSU) placement can be chosen in case of failure of non-invasive therapies (such as local estrogen or physical therapy) and if the clinical examination shows an urethral hypermobility. The use of ultrasound can help in this choice. Although rare, complications of MSU can sometimes cause disabling symptoms and be difficult to diagnose. Introital or trans-labial ltrasound can help diagnose them. The objective of this work was to describe the realization of ultrasound of stress urinary incontinence before or after the placement of a MSU, in order to make their realization easier for young surgeons which can use them in current practice.
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Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo , Incontinencia Urinaria , Humanos , Adulto , Femenino , Incontinencia Urinaria de Esfuerzo/diagnóstico por imagen , Incontinencia Urinaria de Esfuerzo/cirugía , Cabestrillo Suburetral/efectos adversos , Incontinencia Urinaria/cirugía , Vagina/cirugía , Procedimientos Quirúrgicos Urológicos/efectos adversosRESUMEN
INTRODUCTION: Inflammatory and sensory chronic bladder diseases have a significant impact on quality of life. These pathologies share alteration of the layer between urine and urothelium, making the use of topical agents appropriate. OBJECTIVES: Review the efficacy and tolerance of intravesical treatments for these pathologies. Give practical guidelines for the use of agents currently available in France. METHOD: A narrative review was performed in March 2021 using PubMed/MEDLINE, Google Scholar and the international guidelines. Pharmaceutical companies and pharmacies were interviewed. RESULTS: Although numerous molecules were tested over the last 5 decades, only dimethylsulfoxyde and glycosaminoglycans are available in France today. Results are promising: response rates are up to 95% and 84% respectively in bladder pain syndrome. In urinary tract infections, glycosaminoglycans could decrease annual number of cystitis by 2.56 (95% confidence interval (CI) -3.86, -1.26; P<0.001) and increase the time to first cystitis recurrence by 130 days (95% CI: 5.84 - 254.26; P=0.04). In radiation cystitis, results could be comparable to hyperbaric oxygen regarding pain and frequency of voiding (-1.31±1.3 visual analogic scale et -1.5±1.4 voiding per day, respectively, at 12 months, P<0.01). However, literature has a low level of evidence. CONCLUSION: Chronic bladder diseases have limited treatment options. Intravesical agents are a good alternative, although their cost is significant and their outcome uncertain.
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Cistitis Intersticial , Cistitis , Administración Intravesical , Enfermedad Crónica , Cistitis/tratamiento farmacológico , Cistitis Intersticial/tratamiento farmacológico , Femenino , Glicosaminoglicanos/uso terapéutico , Humanos , Masculino , Calidad de VidaRESUMEN
OBJECTIVE: To determine the usefulness of mid-urethral slings (MUS) in the surgical management of women presenting with urinary stress incontinence (USI) METHOD: A consensus committee of multidisciplinary experts (CUROPF) was convened and focused on PICO questions concerning the efficacy and safety of MUS surgery compared to other procedures and concerning which approach (retropubic (RP) vs transobturator (TO)) should be proposed as a first-line MUS surgery for specific subpopulations (obese; intrinsic sphincteric deficiency (ISD); elderly) RESULTS: As compared to other procedures (urethral bulking agents, traditional slings and open colposuspension), the MUS procedure should be proposed as the first-line surgical therapy (strong agreement). MUS surgery can be associated with complications and proper pre-operative informed consent is mandatory (strong agreement). Mini-slings (SIS/SIMS) should only be proposed in clinical trials (strong agreement). Both RP and TO approaches may be proposed for the insertion of MUS (strong agreement). However, if the woman is willing to accept a moderate increase in per-operative risk, the RP approach should be preferred (strong agreement) since it is associated with higher very long-term cure rates and as it is possible to completely remove the sling surgically if a severe complication occurs. The RP approach should be used for the insertion of MUS in a woman presenting with ISD (strong agreement). Either the RP or TO approach should be used for the insertion of MUS in an obese woman presenting with USI (strong agreement). In very obese women (BMI ≥35-40kg/m2), weight loss should be preferred prior to MUS surgery and bariatric surgery should be discussed (strong agreement) CONCLUSION: The current Opinion provides an appropriate strategy for both the selection of patients and the best therapeutic approach in women presenting with USI.
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Cabestrillo Suburetral , Enfermedades Uretrales , Incontinencia Urinaria de Esfuerzo , Anciano , Femenino , Humanos , Masculino , Cabestrillo Suburetral/efectos adversos , Resultado del Tratamiento , Uretra , Enfermedades Uretrales/complicaciones , Incontinencia Urinaria de Esfuerzo/etiología , Incontinencia Urinaria de Esfuerzo/cirugía , Procedimientos Quirúrgicos Urológicos/métodosRESUMEN
OBJECTIVE: To assess the incidence of serious complications and reoperations for recurrence after surgery for pelvic organ prolapse (POP) and compare the three most common types of repair. DESIGN: Prospective cohort study using a registry. SETTING: Nineteen French surgical centres. POPULATION: A total of 2309 women participated between 2017 and 2019. METHODS: A multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups. MAIN OUTCOME MEASURES: Serious complications and subsequent reoperations for POP recurrence. RESULTS: The median follow-up time was 17.6 months. Surgeries were native tissue vaginal repairs (n = 504), transvaginal mesh placements (n = 692) and laparoscopic sacropexies with mesh (n = 1113). Serious complications occurred among 52 women (2.3%), and reoperation for POP recurrence was required for 32 women (1.4%). At 1 year the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair, 3.9% for transvaginal mesh and 2.2% for sacropexy, and the rates for reoperation for recurrence of POP were 1.5, 0.7 and 1.1%, respectively. Compared with native tissue vaginal repair, the risk of serious complications was higher in the transvaginal mesh group (weighted hazard ratio, wHR 3.84, 95% CI 2.43-6.08) and the sacropexy group (wHR 2.48, 95% CI 1.45-4.23), whereas the risk of reoperation for prolapse recurrence was lower in both the transvaginal mesh (wHR 0.22, 95% CI 0.13-0.39) and sacropexy (wHR 0.29, 95% CI 0.18-0.47) groups. CONCLUSIONS: Our results suggest that native tissue vaginal repairs have the lowest risk of serious complications but the highest risk of reoperation for recurrence. These results are useful for informing women and for shared decision making. TWEETABLE ABSTRACT: Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair.
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Prolapso de Órgano Pélvico/cirugía , Complicaciones Posoperatorias/etiología , Mallas Quirúrgicas/efectos adversos , Vagina/cirugía , Anciano , Femenino , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Laparoscopía/efectos adversos , Persona de Mediana Edad , Prolapso de Órgano Pélvico/epidemiología , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Recurrencia , Sistema de Registros , Reoperación/estadística & datos numéricos , Factores de RiesgoRESUMEN
OBJECTIVE: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years. DESIGN: Extended follow up of a randomised trial. SETTING: Eleven centres. POPULATION: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP-Q], aged 45-75 years without previous prolapse surgery. METHODS: Synthetic non-absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM). MAIN OUTCOME MEASURES: Functional outcomes (pelvic floor distress inventory [PFDI-20] as primary outcome); anatomical assessment (POP-Q), composite outcome of success; re-interventions for complications. RESULTS: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI-20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference -7.2 points; 95% CI -14.0 to -0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61-81% versus TVM 71%, 62-81%; hazard ratio 0.92, 95% CI 0.55-1.54; P = 0.75) were similar. POP-Q measurements did not differ, except for point C (LS -57 mm versus TVM -48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0-4.7%) than after TVM (8.7%, 3.4-13.7%; hazard ratio 4.6, 95% CI 1.007-21.0, P = 0.049)). CONCLUSIONS: Both techniques provided improvement and similar success rates. LS had a better benefit-harm balance with fewer re-interventions due to complications. TVM remains an option when LS is not feasible. TWEETABLE ABSTRACT: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM).
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Cistocele/cirugía , Anciano , Femenino , Estudios de Seguimiento , Francia , Humanos , Laparoscopía , Persona de Mediana Edad , Mallas Quirúrgicas , Resultado del Tratamiento , VaginaRESUMEN
INTRODUCTION: Placement of a mid-urethral sling is the gold standard in the surgical management of stress urinary incontinence in women in France. The cure rate of this material is no longer to be demonstrated, but the per- and post-operative complications are currently the subject of a growing controversy not only in Europe but also across the Channel and across the Atlantic, having led to the modification of operative indications. In France, recommendations are also evolving with a stricter framework for indications for surgery by multidisciplinary consultation meeting and an obligation for postoperative follow-up in the short and long term. OBJECTIVES: In this context, CUROPF realized a review of the literature bringing together the available scientific evidence concerning the occurrence of per- and post-operative complications relating to the installation of mid urethral sling. The bibliographic search was carried out using the Medline database and 123 articles were selected. RESULTS: Analysis of the data highlights various complications, depending on the implanted material, the patient and the indication for surgery. The retro-pubic mid urethral sling provides more bladder erosion during surgery (up to 14%), more suprapubic pain (up to 4%) and more acute urinary retention (up to 19,7%) and postoperative dysuria (up to 26%). The trans obturator mid-urethral sling is responsible for more vaginal erosion during the operation (up to 10,9%), more lower limb pain of neurological origin (up to 26,7%). The risk of developing over active bladder is similar in both procedures (up to 33%). But these risks of complications must be balanced by the strong impact of urinary incontinence surgery on the overall quality of life of these women. CONCLUSION: Thus, surgical failure and long term complications exist but should not limit the surgical management of stress urinary incontinence with mid urethral tape. Women should be treated with individualized decision-making process and long-term follow -up is necessary.
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Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo , Urología , Femenino , Humanos , Calidad de Vida , Cabestrillo Suburetral/efectos adversos , Resultado del Tratamiento , Incontinencia Urinaria de Esfuerzo/cirugía , Procedimientos Quirúrgicos Urológicos/efectos adversosRESUMEN
INTRODUCTION: Vaginal LASER therapy is increasingly used in the field of urogynecology, but several points remain unclear. Our goal was to produce a systematic review of available evidence and provide a critical appraisal of available data. METHODS: A systematic review until march 2020 was conducted using PubMed/MEDLINE, Cochrane and Embase databases. All studies about vaginal LASER use in the field of urogynecology were included. RESULTS: Forty studies have been included (8 for genitourinary syndrome of menopause, 19 for stress urinary incontinence, 3 for overactive bladder, 7 for urogenital prolapse, 3 for other indications). Data were heterogeneous, and level of evidence was weak or very weak. Few studies were comparative, and only 3 were randomized). Mild improvement of symptoms and quality of life and limited satisfaction were seen for genitourinary syndrome, stress urinary incontinence, overactive bladder and prolapse. Few adverse events were reported. However, major methodological biases were noted regarding efficacy and safety evaluation. No long-term results were available. CONCLUSIONS: While Vaginal LASER therapy seem to provide encouraging results, the level of evidence supporting its use was weak, especially regarding long-term outcomes. Studies of better quality are warranted before any recommendation can be made. Current use should be limited to clinical research.
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Terapia por Láser , Incontinencia Urinaria de Esfuerzo , Urología , Femenino , Humanos , Rayos Láser , Calidad de Vida , Incontinencia Urinaria de Esfuerzo/cirugía , VaginaRESUMEN
BACKGROUND: Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh-related complications. Surgical techniques mainly consist in anterior colporraphy and vaginal patch plastron. However, success rates of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. To date, high-quality data comparing vaginal native tissue procedures are still lacking. METHODS: Herein we aimed to describe the design of the first randomized controlled trial (TAPP) comparing anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support anchored on the tendinous arch of the pelvic fascia by lateral sutures) techniques. Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional. The primary endpoint will be the success rate 1 year after surgery with a composite of objective and subjective measures (Aa and Ba points < 0 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment). DISCUSSION: A prospective study has found a success rate at 35% for anterior colporraphy based on a combined definition, both anatomic and functional, as recently recommended. However, the definition of anatomic was strict (POP-Q< 2), while it seems that the best definition of anatomic success is "no prolapse among the hymen", that is to say Aa and Ba points from the POP-Q classification < 0. We hypothesize that vaginal patch plastron will have a better anatomic and functional success comparatively to anterior colporraphy because native tissue is added, as it corrects both median and lateral cystoceles thanks to bilateral paravaginal suspension. TRIAL REGISTRATION: CHU LIMOGES is the sponsor of this research (n°87RI18_0013). This research is supported by the French Department of Health (PHRC 2018-A03476-49) and will be conducted with the support of DGOS (PHRC interregional - GIRCI SOHO). The study protocol was approved by the Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019. The trial is registered in the ClinicalTrials.gov registry ( NCT03875989 ).
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Diafragma Pélvico/cirugía , Prolapso de Órgano Pélvico/cirugía , Procedimientos de Cirugía Plástica/métodos , Vagina/cirugía , Femenino , Francia , Humanos , Estudios Multicéntricos como Asunto , Satisfacción del Paciente , Estudios Prospectivos , Diseño de Prótesis , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
INTRODUCTION: The objective of this study was to evaluate the long-term anatomical and functional efficacy, but also the safety of tension-free vaginal mesh in cystocele repair. METHODS: This retrospective and monocentric study included 90 women who underwent a prolapse repair between June 2006 and November 2008. A light-weight polypropylene vaginal mesh (22g/m2, Novasilk COLOPLAST®) was used without any fixation. Females were followed at 1 month, 1 year, 3 years and 6 years. Only long-term results are presented in this study. The anatomical result was assessed by the POP-Q classification and the functional results by standardized symptoms (PFDI-20), sexuality (PISQ-12) and quality of life (PFIQ-7) questionnaires. RESULTS: 6 years after surgery, the follow-up rate was 74%. Anatomically, the prolapse recurrence rate (Ba≥0) was 17% (n=8). Functionally, the overall patient satisfaction rate was 89%. Quality of life and symptoms scores (4,11±8.45 vs. 17.5±14.4 and 35.8±15.9 vs 94±23.4 respectively) were significantly improved (p<0.001). Concerning the prevalence of the complication, the retraction and exposition rate was 1.7% (n=1) and a re-intervention rate was 6.7% (n=4). The rate of de novo dyspareunia was 1.7% (n=1). CONCLUSION: In this short retrospective series of vaginal mesh interposition for cystocele repair, the prevalence of medium-term patient satisfaction was high.
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Cistocele/cirugía , Mallas Quirúrgicas , Adulto , Anciano , Anciano de 80 o más Años , Diseño de Equipo , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , VaginaRESUMEN
OBJECTIVE: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. DESIGN: Prospective longitudinal cohort study using a surgical registry. SETTING: Thirteen public hospitals in France. POPULATION: A cohort of 1873 women undergoing surgery between February 2017 and August 2018. METHODS: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. MAIN OUTCOME MEASURES: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. RESULTS: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. CONCLUSIONS: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. TWEETABLE ABSTRACT: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.
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Diafragma Pélvico/cirugía , Prolapso de Órgano Pélvico/cirugía , Mallas Quirúrgicas/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Análisis de Varianza , Colposcopía/efectos adversos , Colposcopía/mortalidad , Colposcopía/estadística & datos numéricos , Femenino , Francia/epidemiología , Humanos , Incidencia , Complicaciones Intraoperatorias/etiología , Complicaciones Intraoperatorias/mortalidad , Persona de Mediana Edad , Prolapso de Órgano Pélvico/mortalidad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Estudios Prospectivos , Sistema de Registros , Cabestrillo Suburetral/efectos adversos , Cabestrillo Suburetral/estadística & datos numéricos , Mallas Quirúrgicas/estadística & datos numéricos , Centros Quirúrgicos/estadística & datos numéricos , Adulto JovenRESUMEN
OBJECTIVES: To evaluate the feasibility and functional urinary and digestive results of nerve sparing techniques in endometriosis surgery. METHODS: A research on the medline/pubmed database using specific keywords (nerve sparing, endometriosis, pelvic nerves) identified 7 publications among about 50 whose purpose was to describe the feasibility, the techniques and the functional results of nerve preservation in this indication. Among them there are: 2 uncontrolled retrospective studies, 3 prospective non-randomized studies, a meta-analysis and a review of the literature. RESULTS: Nerve preservation requires a perfect knowledge of the anatomy of the pelvic autonomic system. The laparoscopic approach is preferred by the different authors due to its anatomical advantage. The feasibility of this technique seems to be demonstrated despite certain limitations in the different studies and depending of the retroperitoneal extension of the lesions. When feasible, it is likely to significantly improve postoperative urinary function (urinary retention) compared to a conventional technique. It is observed no difference regarding digestive function. CONCLUSIONS: Nerve sparing in this indication is a technique the feasibility of which has been demonstrated and is subject to the topography and extent of the disease. In the absence of invasion or entrapment of pelvic autonomic nerves by endometriosis, this technique improves postoperative voiding function (NP3). During pelvic surgery for endometriosis, it is recommended to identify and preserve autonomic pelvic nerves whenever possible (GradeC).
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Endometriosis/cirugía , Traumatismos de los Nervios Periféricos/prevención & control , Femenino , Humanos , Plexo Hipogástrico , Laparoscopía , Tratamientos Conservadores del Órgano , Pelvis/inervación , Trastornos Urinarios/prevención & controlRESUMEN
INTRODUCTION AND HYPOTHESIS: This aim of this study was to evaluate the feasibility and usefulness of an ovine model for training in vaginal surgery. METHODS: Four senior urogynaecological surgeons and five residents attended five sessions of vaginal surgery for pelvic organ prolapse (POP) in five old multiparous female sheep. Urogynaecological examinations were performed and measurements similar to the POP-Q classification in humans were obtained. Standard POP surgical procedures with and without mesh were performed. A pelvic CT scan was done on one animal and the structures were compared with the pelvic structures in a woman. After the feasibility of vaginal surgery had been established in three cadavers, surgery was performed in two living animals under general anaesthesia and was followed by laparoscopy to explore the internal pelvic anatomy. RESULTS: We found anatomic similarities in the vaginal and pelvic structures between sheep and women. After caudal traction on the cervix, all five sheep had significant POP of stage 3 or 4. We proved the feasibility of all types of vaginal surgery in this animal model: traditional anterior and posterior repair, apex fixation and anterior wall repair with mesh. The video shows the internal pelvic anatomy and different vaginal procedures. CONCLUSION: This study showed that training in vaginal surgery for POP is feasible and useful in an animal model, the ewe, that has vaginal and pelvic structures very similar to those in women.
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Procedimientos Quirúrgicos Ginecológicos/educación , Modelos Animales , Prolapso de Órgano Pélvico/cirugía , Ovinos/cirugía , Vagina/cirugía , Animales , FemeninoRESUMEN
BACKGROUND: Cystocele is a frequent and invalidating type of genital prolapse in woman. Sacropexy using synthetic mesh is considered the surgical gold standard, and the laparoscopic approach has supplanted the open abdominal route because it offers the same anatomical results with a lower morbidity. The use of mesh through the vaginal route may have many advantages: easiness to perform, shorter operative time and recovery, but may increase morbidity. In France, both laparoscopic sacropexy and vaginal mesh are commonly used to treat cystoceles. The French Haute Autorité de santé (HAS) has highlighted the lack of evaluation of safety assessment for vaginal meshes. METHOD/DESIGN: The main objective of the study is to compare the morbidity of laparoscopic sacropexy with vaginal mesh for cystocele repair. The primary endpoint will be the rate of surgical complications greater or equal to grade 2 of the Clavien-Dindo classification at 1-year follow-up. The secondary aims are to compare the functional results in the medium term (sexuality, urinary and bowel symptoms, pain), the impact on quality of life as well as anatomical results. PROSPERE is a randomized controlled trial conducted in 12 participating French hospitals. 262 patients, aged 45 to 75years old, with cystocele greater or equal to stage 2 of the POP-Q classification (isolated or not) will be included. Exclusion criterias are a previous surgical POP repair, and inability or contra-indication to one or the other technique. We have designed this study to answer the question of the choice between laparoscopic sacropexy and vaginal mesh for the treatment of cystocele. The PROSPERE trial aims to help better determine the indications for one or the other of these techniques, which are currently based on subjective choices or school attitudes. This is the reason why competent authorities have asked for such studies.