Impact of age on tumor size in vulvar cancer: A multicenter study by the Francogyn group.

OBJECTIVE: Vulvar cancer is a rare pathology affecting mainly elderly women. This study aims to evaluate the impact of age on tumor size in vulvar cancer. MATERIAL AND METHODS: This was a multicenter retrospective observational study carried out between January 1, 1998, and December 31, 2020, in patients operated on for vulvar cancer. Univariate analysis was performed according to patients' age ≥ or <65 years. Factors associated with tumor size found to be significant according to age were then included in a multiple linear regression model. RESULTS: Of the 382 patients included, there were 133 patients aged <65 years and 249 ≥ 65 years. Radical total vulvectomy surgeries were more frequently performed in women ≥65 years (n = 72 (28.9 %) versus n = 20 (15 %); p = 0.004). The median histological tumor size and interquartile range was 20 mm [13-29] in the <65 years and 30 mm [15-42] in patients ≥65 years (p = 0.001). Multiple linear regression showed that age ≥65 years had a regression coefficient of 7.15 95 % CI [2.32; 11.99] (p = 0.004), constituting a risk factor for larger histological tumour size. Patients aged ≥65 years old had a higher early complication rate (n = 150 (62 %) versus n = 56 (42.7 %), p = 0.001). They also had a greater risk of recurrence (HR = 1.89 (95%CI (1.24-2.89)), p = 0.003) with a worse overall survival (HR = 5.64 (95%CI (1.70-18.68)), p = 0.005). CONCLUSION: Age is a risk factor for larger tumor size, leading to more radical surgery and a greater risk of complications in already fragile patients, with a greater risk of recurrence and an impact on overall survival.

Risk factors for postoperative pain after cystocele repair with mesh.

INTRODUCTION AND HYPOTHESIS: Prolapse is a common condition seen in women and its therapeutical management consists first and foremost of surgery. Postoperative pain is one of the most common side effects seen after surgery. The objective of this study was to identify risk factors for postoperative pain after cystocele repair with mesh. METHODS: This is a secondary analysis of the multicenter randomized trial PROSPERE, which compared cystocele repair with mesh according to the vaginal or laparoscopic approach. The presence of postoperative pain was assessed by a pain-specific self-reported questionnaire (Questionnaire de Baudelocque). The statistical analysis is based on the Wilcoxon, Chi-squared, and Fisher's tests. RESULTS: The prevalence of postoperative pain (pain persisting more than 6 months) was 39% (80 out of 205, 95% CI 32.4-46.1), with 6.3% (13 out of 205) of chronic pain reports. Preoperative pain was the only statistically significant risk factor OR = 2.32 (p = 0,007; 95% CI 1.24-4.36). CONCLUSIONS: Surgeons must be careful with preoperative painful prolapse and should inform their patient of the risk of developing postoperative chronic pain.

Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry.

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.

Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial.

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).

[Cesarean scare niche: Definition, diagnosis, risk factors, prevention, symptoms, adverse effects, and treatments]. / Isthmocèle : définition, diagnostic, facteurs de risque, prévention, symptômes, complications, et traitements.

OBJECTIVES: To review the definitions, diagnostic methods, risk factors, symptoms, and treatments for caesarean scar niche. METHODS: Review of the literature, critical reflection, and pragmatic advice. RESULTS: There is no consensus on the definition of caesarean scar niche. Some suggest an indentation≥2mm of the myometrium of the caesarean scar, but this is present in more than half of women with caesarean history and takes no account of woman's symptoms. The most popular diagnostic method is ultrasound±hysterosonography. Risks factors for niche are multiple Caesareans, Cesarean during labor with too low incision, and retroverted uterus. Symptoms include abnormal gynaecologic bleeding and pelvic pain, and their presence establish the "Caesarean scar syndrome". The risks of pregnancy with niche is poorly studied, but pregnancy is not contraindicated, even if the niche is untreated. The treatment of caesarean scar niche is mainly surgery and conservative. The former should be reserved for symptomatic patients, and those with secondary infertility and fertility treatment failure. Patients with residual myometrium thickness≥2.5mm may benefit from first-line hysteroscopic treatment, whereas a laparoscopic or vaginal approach could be offered in other cases. CONCLUSIONS: A pragmatic definition of caesarean scar niche as a disease including symptoms is the necessary prerequisite for the management of women. The treatment is mainly surgical, or conservative depending on the desire for subsequent pregnancy.

Impact of surgical restaging on recurrence in patients with borderline ovarian tumors: A meta-analysis.

OBJECTIVE: The benefits of restaging surgery for patients with a borderline ovarian tumor (BOT) discovered on initial surgery are debatable. We performed a meta-analysis to evaluate the role of restaging surgery on recurrence in patients with BOTs. STUDY DESIGN: We systematically reviewed published studies comparing restaging surgery and incomplete surgery in BOT patients from January 1985 to December 2017. Endpoints were recurrence and mortality rates. Study design features that possibly affected participant selection, reporting of recurrence and death, and manuscript publication were assessed. For pooled estimates of the effect of restaging surgery on recurrence, fixed-effect meta-analytical models were used. RESULTS: Of the 577 articles initially selected, four retrospective observational studies (Restaging group: 166 patients; Non-Restaging group: 394 patients) met our research criteria. No significant differences in terms of recurrence between the two groups were observed (pooled Peto Odds Ratio [OR] = 0.88; 95 % confidence interval [CI]: 0.41-1.92). The number of deaths was insufficient for statistical analysis. CONCLUSIONS: This meta-analysis based on retrospective studies, suggests that restaging surgery does not significantly reduce recurrence in patients with BOT.

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

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.

ENDORECT: a preoperative score to accurately predict rectosigmoid involvement in patients with endometriosis.

STUDY QUESTION: Could we construct and validate a preoperative score to predict rectosigmoid involvement in endometriosis (RE)? SUMMARY ANSWER: We developed a simple preoperative score (ENDORECT) to predict RE. WHAT IS KNOWN ALREADY: Accurate preoperative classification is important to optimize the surgical approach for patients with endometriosis but there is currently no reliable first-line examination to determine RE. STUDY DESIGN SIZE DURATION: This was a single-centre observational study including all women (N = 119) who underwent complete surgery for endometriosis between January 2011 and June 2016 in the Gynaecological Department of the University Hospital of Poissy Saint-Germain en Laye. PARTICIPANTS/MATERIALS SETTING METHODS: Of the 119 women, 47 had RE and 72 did not. Two-thirds of the patients were randomly selected to derive the predictive score based on multiple logistic regression with internal validation by bootstrap. We used information from a self-assessment questionnaire, digital and speculum examination, transvaginal ultrasound and MRI. The score was then applied to the remaining sample of patients for validation. MAIN RESULTS AND THE ROLE OF CHANCE: Four variables were independently associated with RE: palpation of a posterior nodule on digital examination (aOR=5.6; 95%CI [1.7-21.8]); a UBESS score of 3 on ultrasonography (aOR=4.9; 95%CI [1.4-19.8); RE infiltration on MRI (aOR=6.8; 95%CI [2-25.5]); and presence of blood in the stools during menstruation (aOR=5.2; 95%CI [1.3-24.7]). The ROC-AUC of the model was 0.86 (95%CI [0.77-0.94]) and the bootstrap procedure showed that the model was stable. The ENDORECT score was derived from these four criteria and three risk groups were identified: the high-risk group (score>17) had a probability of RE of 100% with an specificity (Sp) of 100%, postive likelihood ratio (Lr+)>10; the intermediate-risk group (score: 7-17) had a probability of RE of 42%; and the low-risk group (score=0), with a sensitivity (Se) of 97%, negative likelihood ratio (Lr-) of 0.07 and a probability of RE of 5%. In the validation cohort, a score >17 predicted RE with an Sp of 96, Lr+ of 9.2, and probability of RE of 83%. Patients in this sample with a score=0, had an Se of 100%, Lr- of 0 and a probability of RE of 0%. LIMITATIONS REASONS FOR CAUTION: The single-centre recruitment and over-representation of RE could constitute a referral bias. WIDER IMPLICATIONS OF THE FINDINGS: The use of a preoperative predictive score could facilitate patient counselling and guide surgical management. Both MRI and transvaginal ultrasound provide independent information and are useful before surgery for RE. STUDY FUNDING/COMPETING INTERESTS: No financial support was specifically received for this study. The authors declare no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

Validation of the Sexual Activity Questionnaire in women with endometriosis.

STUDY QUESTION: Is the Sexual Activity Questionnaire (SAQ) a valid tool for patients treated for symptomatic endometriosis? SUMMARY ANSWER: For women having surgical treatment for endometriosis, we determined that the SAQ is a valid and responsive tool. WHAT IS KNOWN ALREADY: Endometriosis adversely affects sexual quality of life. Suitable validated sexual quality of life instruments for endometriosis are lacking both in clinical practice and for research. STUDY, DESIGN, SIZE, DURATION: A total of 367 women with proven endometriosis undergoing medical or surgical treatment were included in an observational study conducted between 1 January 2012 and 31 December 2014 in two French tertiary care centers. Both hospitals are reference centers for endometriosis treatment. Of these 367 women, 267 were sexually active and constituted the baseline population. PARTICPANTS/MATERIALS, SETTINGS, METHODS: Women >18 years old with histological or radiological proven endometriosis, consulting for painful symptoms of at least 3 months duration, infertility, or other symptoms (bleeding, cysts) were invited to complete self-administered questionnaires before (T0) and 12 months after treatment (T1). Tests of data quality included descriptive statistics of the data, missing data levels, floor and ceiling effects, structural validity and internal consistency.The construct validity was obtained by testing presupposed relationships between previously established SAQ scores and prespecified characteristics of the patients by comparing different subgroups of patients at T0. Sensitivity to change was subsequently calculated by comparing the SAQ score between T1 and T0 overall and for different subgroups of treatment. Effect sizes (to T1) were calculated according to Cohen's method. The minimally important difference was estimated by a step-wise triangulation approach (including anchor-based method). MAIN RESULTS AND THE ROLE OF CHANCE: In total, 267 sexually active patients (204 surgical and 63 medical treatment) completed the SAQ at T0 and 136 (50.9%) at T1. The SAQ score ranged from 2.0 to 28.0 (mean ± SD: 16.8 ± 5.7).The SAQ score was one-dimensional according to the scree plot with good internal consistency (Cronbach alpha = 0.78, 95% CI 0.74-0.81) and had good discriminative ability according to pain descriptors and quality of life in endometriosis. The SAQ was responsive in patients treated by surgery but the effect size was low (0.3, 95% CI (0.0-0.6), P = 0.01). The minimally important difference was determined at 2.2. LIMITATIONS, REASONS FOR CAUTION: The effect size for medical treatment was non-significant. Other effect sizes were low but statistically significant. This could be explained by lower libido due to progestin intake, which was used for both surgically and medically treated patients. WIDER IMPLICATIONS OF THE FINDINGS: The SAQ is easy to use, valid and effective in assessing sexual quality of life in patients with endometriosis. This patient-reported score could be used as a primary outcome for future clinical studies. The minimally important difference estimation will be useful for future research. We recommend using 2.2 for the minimally important difference of the SAQ. STUDY FUNDING/COMPETING INTEREST(S): This work was funded by the 'Direction à la Recherche Clinique et à l'Innovation' of Versailles, France and the 'Institut de Recherche en Santé de la Femme' (IRSF). The authors have no conflicts of interest to declare.

[Endometriosis: Assessment of the Ultrasound-Based Endometriosis Staging System score (UBESS) in predicting surgical difficulty]. / Endométriose : évaluation du score Ultrasound-Based Endometriosis Staging System (UBESS) dans la prédiction de la difficulté chirurgicale.

OBJECTIVES: Surgical management of endometriosis may require different levels of surgical skill which influences the orientation of the patient. The Ultrasound-Based Endometriosis Staging System (UBESS) is a score developed in 2016 to predict the difficulty of surgery. To study the correlation between UBESS score and two main surgical classifications in the literature. METHODS: Study performed at the center of Poissy, France, between July 2016 and December 2017. Patients who underwent prospective UBESS staging then operated of their endometriosis were included. The patients were classified according to the levels of surgical difficulty of the Royal College of Obstetricians and Gynecologists (RCOG) and the classification created by Chi et al. The criterion of judgment was the correlation between the UBESS stages and RCOG and CHI levels. In a second analysis, we determined the predictive value of the operative plan for items included in the systematic sonographic evaluation described by Menakaya et al. RESULTS: Thirty-three patients were included in the study. Correlation was found to be low between UBESS and RCOG (θ=0.22) and between UBESS and CHI (θ=0.30). The prediction of the operative plan was good for endometrioma, sites specific tenderness, sliding sign, vaginal and digestive tract involvement; but modest for the anterior compartment and uterosacrals ligaments. CONCLUSION: In our study on a small number of patients, the UBESS score does not adequately predict the surgical difficulty. Taken separately, the items of systematic sonographic evaluation based on 5 domains successfully predict the operative plan.

Is training sufficient for ultrasound operators to diagnose deep infiltrating endometriosis and bowel involvement by transvaginal ultrasound?

OBJECTIVES: To assess and compare the diagnostic accuracy of transvaginal ultrasonography (TVUS) by trained or untrained ultrasound operators in deep infiltrating endometriosis (DIE) imaging, for diagnosing DIE and bowel involvement. METHODS: This was an observational study of patients with clinically suspected DIE operated in a reference center. TVUS was performed pre-operatively by a trained or/and untrained ultrasound operator to search for DIE and rectal involvement. During surgery, DIE was diagnosed according to macroscopic and histological criteria. Sensitivity (Se), specificity (Sp) and c-index were calculated with 95% confidence intervals for trained and untrained operators, if TVUS results were significantly predictive of DIE and rectal involvement at p<0.05. RESULTS: 115 patients were included: 100 (87%) had DIE and 34 (29.6%) had bowel involvement. TVUS was performed by a trained ultrasound operator for 70 patients and by an untrained one for 56 patients. When performed by a trained operator, TVUS significantly predicted DIE with a Se of 58% (95% CI, 46-70), a Sp of 87.5% (95% CI, 63-100) and a c-index of 0.73 (95% CI, 0.59-0.87). TVUS performed by an untrained operator was not significantly predictive of DIE (p=0.58). Rectal involvement was significantly predicted by TVUS performed by a trained operator with a Se of 40% (95% CI, 23-59), a Sp of 93% (95% CI, 86-100) and a c-index of 0.67 (95% CI, 0.56-0.77). None of the untrained ultrasound operators diagnosed a bowel involvement. CONCLUSION: TVUS is not sufficient to diagnose DIE and bowel involvement, in particular when performed by untrained ultrasound operators.

Management of endometriosis: CNGOF/HAS clinical practice guidelines - Short version.

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.

[Management of endometriosis: CNGOF-HAS practice guidelines (short version)]. / Prise en charge de l'endométriose : recommandations pour la pratique clinique CNGOF-HAS (texte court).

First-line investigations to diagnose endometriosis are clinical examination and pelvic ultrasound. Second-line investigations include pelvic examination performed by a referent clinician, transvaginal ultrasound performed by a referent echographist, and pelvic MRI. It is recommended to treat endometriosis when it is symptomatic. First-line hormonal treatments recommended for the management of painful endometriosis are combined with hormonal contraceptives or levonorgestrel 52mg IUD. There is no evidence to recommend systematic preoperative hormonal therapy for the unique purpose of preventing the risk of surgical complications or facilitating surgery. After endometriosis surgery, combined hormonal contraceptives or levonorgestrel SIU 52mg are recommended as first-line therapy in the absence of desire of pregnancy. In case of initial treatment failure, recurrence, or multiple organ involvement by endometriosis, medico-surgical and multidisciplinary discussion is recommended. The laparoscopic approach is recommended for the surgical treatment of endometriosis. HRT may be offered in postmenopausal women operated for endometriosis. In case of infertility related to endometriosis, it is not recommended to prescribe anti-gonadotropic hormone therapy to increase the rate of spontaneous pregnancy, including postoperatively. The possibilities of fertility preservation should be discussed with the patient in case of surgery for ovarian endometrioma.

[Expectations of women with endometriosis: What information to deliver? CNGOF-HAS Endometriosis Guidelines]. / Attentes des femmes atteintes d'endométriose : quelle information apporter ? RPC Endométriose CNGOF-HAS.

Women with endometriosis often say that the information doctors give them should be improved. Patient support groups can provide missing information but may lack objectivity, or reliability, and may even generate anxiety or even harm their health. Clear unbiased medical information is the ideal. New patients with endometriosis wish to be taken seriously by primary care physicians, and be referred quickly to a specialist without further unnecessary investigation or delay. The diagnosis of endometriosis should ideally be made quickly, and should clearly specify the nature of the disease, its evolution, and its consequences on quality of life, relationships, and fertility. When choosing a treatment, information should state the risks of each treatment, the risks of recurrence long term, and the therapeutic alternatives. These should include conventional medical treatment, lifestyle adaptation, or alternative therapies. In case of surgery, prior written information should be provided, the likely scar appearance, the short and long term consequences in terms of pain, postoperative recovery time and complication rates. Once the surgery is performed, the degree of endometriotic involvement and the treatment undertaken should be explained. At discharge, patients should be told the expected recovery time, and the consequences of the operation on daily life.

[Specific clinical signs suggestive of endometriosis (excluding adenomyosis) and questionnaires of symptoms, pain and quality of life: CNGOF-HAS Endometriosis Guidelines]. / Signes spécifiques cliniques évocateurs de l'endométriose (hors adénomyose) et questionnaires de symptômes, de douleur et qualité de vie, RPC Endométriose CNGOF-HAS.

In case of consultation for chronic pelvic pain or suspicion of endometriosis, it is recommended to evaluate the pain (intensity, resonance) and to search out the evocative and localizing symptoms of endometriosis (Grade B). The main symptoms suggestive of endometriosis are: severe dysmenorrhea (NP2), deep dyspareunia (NP2), painful defecation during menstruation (NP2), urinary tract symptoms during menstruation (NP2) and infertility (NP2). In patients with chronic pelvic pain, it is recommended to search deep infiltrating endometriosis in patients with painful defecation during menstruation or severe deep dyspareunia (Grade B). It is recommended to search symptoms suggestive of sensitization in painful patients with endometriosis (Grade B). When suggestive symptoms of endometriosis are present, a directed gynecological examination is recommended, where possible, including examination of the posterior vaginal cul-de-sac (Grade C). In assessing pain intensity or evaluating analgesic effectiveness of a treatment, it is recommended to use a scale to measure the intensity of pain (Grade A). In the management of symptomatic endometriosis, it is recommended to evaluate the quality of life (Grade C).

[Epidemiology and diagnosis strategy: CNGOF-HAS Endometriosis Guidelines]. / Épidémiologie et stratégie diagnostique, RPC Endométriose CNGOF­HAS.

Based on the best evidence available, we have provided guidelines for clinical practice to target the nature of endometriosis as a disease, the consequences of its natural history on management, and the clinical and imaging evaluation of the disease according to the level of care (primary care, specialized or referral). The frequency of endometriosis is unknown in the general population; endometriosis requires management when it causes symptoms (pain, infertility) or when it affect the function of an organ. In the absence of symptom, there is no need for follow-up or screening of the disease. Endometriosis may be responsible for various pain symptoms such as severe dysmenorrhea, deep dyspareunia, painful bowel movements or low urinary tract signs increasing with menstruation, or infertility. A careful evaluation of the symptoms and their impact on the quality of life should be made. The first-line examinations for the diagnosis of endometriosis are: digital examination and pelvic ultrasound. The second-line examinations are: the pelvic exam by an expert clinician, the pelvic MRI and/or the transvaginal ultrasound by an expert. MRI and ultrasound carrying different and complementary information. Other examinations may be considered as part of the pre-therapeutic assessment of the disease in case of specialized care. Diagnostic laparoscopy may be suggested in case of clinical suspicion of endometriosis whereas preoperative examinations have not proved the disease, it must be part of a management plan of endometriosis-related pain or infertility. During management, it is recommended to give comprehensive information on the different therapeutic alternatives, the benefits and risks expected from each treatment, the risk of recurrence, fertility, especially before surgery. The information must be personalized and take into account the expectations and preferences of the patient, and accompanied by an information notice given to the patient.

Reducing pre-operative fasting while preserving operating room scheduling flexibility: feasibility and impact on patient discomfort.

BACKGROUND: The need to preserve operating room (OR) scheduling flexibility can challenge adherence to the 2-h pre-operative fasting period recommendation before elective surgery. Our primary objective was to assess the feasibility of a pre-operative carbohydrate (CHO) drink delivery strategy preserving OR scheduling flexibility. METHODS: During the 1st study phase, patients admitted for elective surgery fasted overnight (Control group); during the 2nd phase, patients fasted overnight and received a pre-operative CHO drink (CHO group). CHO delivery time was set to allow any patient to be ready for surgery 30 min ahead of the scheduled time and any patient with an operation scheduled in the afternoon to be ready at 13:00 hours; patients admitted the morning of an early morning operation would not be allowed to take a CHO drink. RESULTS: We included 194 patients in the Control group and 199 in the CHO group. In the CHO group, the morning CHO dose was delivered to 66.3% of the patients (95% CI 59.3-72.9%), with a median pre-operative fasting time period of 4 h 57 min. After excluding patients admitted the morning of an operation scheduled before 10:00 hours, the delivery rate was 77.2% (70.2-83.3%). Patients in the CHO group experienced significantly less pre-operative thirst (median 2 vs. 5 on a 0-10 scale, P < 0.0001) and hunger (0 vs. 2, P < 0.0001) than those in the Control group. CONCLUSION: Although preservation of OR scheduling flexibility resulted in a longer fasting time than recommended, CHO drink can be made available to a large proportion of patients with significantly reduced perioperative discomfort.

[Study of the factors motivating refusal of women to participate to a randomized clinical trial in gynecological surgery. Retrospective observational bicentric study]. / Étude des facteurs motivant le refus des femmes de participer à un essai clinique randomisé en chirurgie gynécologique. Étude observationnelle rétrospective bicentrique.

INTRODUCTION: Randomized controlled trials (RCT) in surgery are often subject to difficulties inherent in the study design and recruitment of patients. Women's participation rate to RCTs in surgery is relatively low and varies from 30 to 70%. These recruitment problems might induce a weak scientific value and even stop the study. Thus, optimizing recruitment is a challenge for surgical research. In contemporary literature, we lack data on motivations and profile of women who refuse to participate in a RCT in surgery. OBJECTIVE: To explore the potentially influential factors affecting women's decision to decline participation in PROSPERE trial, comparing laparoscopic sacrocolpopexy (LSCP) to vaginal mesh for cystocele repair. PATIENT AND METHOD: Retrospective, observational, qualitative, bicentric study conducted in the department of gynecology of Poissy and Lille hospitals. Patients included were those who refused to participate to PROSPERE trial in both centers. Factors of non-participation in the trial were recorded at the time of the first visit. A control group consisted of women who agreed to participate in the trial was also analyzed. RESULTS: In both centers, 139 were eligible to participate in the trial but 35 of them (25%) refused. Thirty-two women agreed to declare their refusal motivations. Vaginal mesh was finally performed in 18 (56,2%) patients and LSCP in 14 patients (43,8%). The control group consisted of 20 women, including 9 operated by vaginal mesh and 11 by LSCP. Patient's characteristics were similar in the both groups. Most influencing factor in refusal for participation was "previous choice of technique" in 50% cases (16/32), followed by "geographical remoteness and difficulties for additional visits" in 40.6% cases (13/32), and finally by "do not accept the concept of randomization" in 21.8% cases (7/32). The most influencing factor in women's acceptance was interest in helping others by "supporting medical research" in 100% cases (20/20), followed by "potential personal benefits and close follow-up" in 60% (12/20). CONCLUSION: Our study identified the most influential factors relevant to women decision-making whether or not to participate in RCT in surgery. A number of factors leading to refusal of participation are potentially correctable leading to better recruitment rates in future RCTs. Optimization of information on the principle of randomization, limiting the number of additional visits could help researchers improve participation rates.