vNOTEsHC : Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopic for large uteri: study protocol for a multicentre randomised controlled trial.

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.

Ultrasonographic gastric volume before unplanned surgery.

We aimed to measure gastric antral cross-sectional area with ultrasound and estimate the gastric volume of 300 patients before unplanned surgery, fasted for at least six hours. Measurements were successfully recorded in 263 semi-recumbent patients. The median (IQR [range]) area was 333 (241-472 [28-1803]) mm2 and the mean (SD) estimated volume was 45.8 (34.0) ml. The area exceeded 410 mm2 in 92/263 (35%) measurements. Body mass index and morphine administration were associated with larger gastric areas on multivariable linear regression analysis, with beta coefficient (95%CI) 0.02 (0.01-0.04), p = 0.01, 0.23 (0.01-0.46), p = 0.04, respectively. Fasting time was not associated with gastric area and therefore could not substitute for ultrasound measurements in this cohort.

Association of Anti-glycan Antibodies and Inflammatory Bowel Disease Course.

BACKGROUND AND AIMS: The usefulness of anti-glycan antibodies alone or combined with anti-Saccharomyces cerevisiae [ASCA] or perinuclear antineutrophil cytoplasmic [pANCA] antibodies for diagnosis of inflammatory bowel disease [IBD], differentiation between Crohn's disease [CD] and ulcerative colitis [UC], disease stratification including IBD phenotype, and also for determination of the course of the disease, remain unclear. METHODS: A large panel of serological anti-glycan carbohydrate antibodies, including anti-mannobioside IgG antibodies [AMCA], anti-chitobioside IgA [ACCA], anti-laminaribioside IgG antibodies [ALCA], anti-laminarin [anti-L] and anti-chitine [anti-C] were measured in the serum from a cohort of 195 patients with IBD] [107 CD and 88 UC]. The respective accuracy of isolated or combined markers for diagnosis, disease differentiation, stratification disease phenotype, and severity of the disease course, defined by a wide panel of criteria obtained from the past medical history, was assessed. RESULTS: The positivity of at least one anti-glycan antibody was detected in a significant higher proportion of CD and UC compared with healthy controls [p < 0.0001 and p < 0.0007, respectively]. Whereas ASCA and ANCA antibody status had the highest efficacy to be associated with CD in comparison with UC (area under receiver operating characteristic curve [AUROC] = 0.70 for each], the adjunction of anti-laminarin antibody substantially improved the differentiation between CD and UC [AUROC = 0.77]. Titres of ACCA [> 51U/ml] and anti-laminarin [> 31U/ml] were significantly linked with a higher association with steroid dependency (odds ratio [OR] =2.0 [1.0-4.0], p = 0.03 and OR = 2.4 [1.1-5.2], p = 0.02, respectively]. We further defined the respective performance of anti-glycan antibodies to discriminate between patients with severe or not severe CD and UC course and determined the associated optimal cut-off values: severe CD course was significantly more likely in case of AMCA > 77U/ml [OR = 4.3; p = 0.002], ASCA > 63U/ml [OR = 3.5; p < 0.009] and at a lesser degree ACCA > 50U/ml [OR = 2.8; p < 0.02] and severe UC course was significantly associated with AMCA > 52U/ml [OR = 3.4; p = 0.04] and ACCA > 25U/ml [OR = 3.0; p < 0.04]. CONCLUSIONS: Anti-glycan antibodies are valuable serological markers, especially AMCA antibodies that may help clinicians to promptly classify patients into high risk for severe disease.

Efficacy of sustained combination therapy for at least 6 months with thiopurines and infliximab in patients with ulcerative colitis in clinical remission: a retrospective multicenter French experience.

BACKGROUND AND AIMS: Long-term benefits of combination therapy (combotherapy) with infliximab (IFX) and azathioprine (AZA) have been less studied in ulcerative colitis (UC) than in Crohn's disease. The aim of the present study was to determine UC disease activity in patients who received at least 6 months of combotherapy, and whether cotreatment for more than 6 months was useful in these patients. METHODS: A retrospective multicenter study was conducted in seven French academic centers from January 2010 to September 2012, including all UC patients having received at least 6 months of combotherapy in prolonged remission off steroids. During the follow-up period, which was divided into trimesters, scheduled IFX was continued as maintenance and AZA could be withdrawn. Assessment of UC activity by trimester was based on the following events: disease relapse defined by clinical relapse requiring a change of treatment, IFX failure, and colectomy. RESULTS: Eighty-two patients were included (mean age 38 years; male:female ratio 1:1) and followed up for a median of 22.3±14.0 months. Comparing 393 trimesters of combotherapy with 282 trimesters of IFX alone, fewer clinical relapses were observed with combotherapy (p = 0.049). Similar results were observed for IFX failure (p = 0.048). No difference was observed for colectomy. Duration of combotherapy longer than 9 months was inversely associated with clinical relapse (hazard ratio = 0.32 [95% confidence interval 0.15-0.70]). CONCLUSIONS: UC patients treated with combotherapy should maintain IFX and AZA for at least 9 months. Further studies are required to determine the optimal duration of combotherapy before stopping AZA in this situation.

Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study.

OBJECTIVE: To present results and to identify predictive factors of early outcome after fenestrated and/or branched endovascular repair (f/b-EVAR) for complex aortic aneurysms, abdominal (AAA) and thoracoabdominal (TAAA). BACKGROUND: Feasibility of f/b-EVAR for complex aneurysms is now established, but little is known about which patients will benefit from this technique. METHODS: Univariate and multivariate analysis of preoperative and intraoperative factors on postoperative mortality and complications was performed on 268 patients (group 1: juxta- and pararenal AAA; group 2: suprarenal and TAAA IV; group 3: TAAA I, II, III) enrolled in a prospective multicenter trial of f/b-EVAR. RESULTS: Thirty-day mortality, in-hospital mortality (IM), and combined mortality and severe complications (CMSC) rates were 6.7%, 10.1%, and 22.0%, respectively. Group belonging (2 or 3 vs 1) was the only preoperative predictive factor of CMSC [hazard ratio (HR) = 2.10; 95% confidence interval (CI): 1.26-3.48; P = 0.0043]. Occurrence of a technical complication and duration of intervention significantly influenced both IM (HR = 4.39; 95% CI: 2.05-9.38; P = 0.0001) and CMSC (HR = 3.07; 95% CI: 1.84-5.11; P < 0.0001). Postoperative events associated with increased IM were spinal cord ischemia (HR = 9.46; 95% CI: 3.98-22.47; P < 0.0001), hemodialysis (HR = 27.44; 95% CI: 12.63-59.61; P < 0.0001), and reintervention (HR = 4.45; 95% CI: 2.03-9.73; P = 0.0002). CONCLUSIONS: Although promising, f/b-EVAR still carries a significant rate of mortality and complications, mostly related to the complexity of the procedure. In these complex cases, new strategies should be investigated to improve outcomes.

Prospective multicentre observational study of lymphedema therapy: POLIT study.

OBJECTIVE: Lymphedema treatment is based on Decongestive Lymphedema Therapy (DLT) with an intensive phase followed by a long-term maintenance phase. This study aimed to observe volume variation over the intensive phase and 6 months later. METHODS: Prospective multicentre observational study of patients with unilateral lymphedema. The primary objective was to assess lymphedema volume variation between baseline, the end of intensive phase and 6 months later. Secondary objectives were to assess the frequency of heaviness limiting limb function and treatments safety predictors for volume reduction. RESULTS: Three hundred and six patients (89.9% women; 59.9±14.3 years old) with upper/lower (n=184/122) limb lymphedema were included. At the end of the intensive phase, median excess lymphedema volume reduction was 31.0% (41.7-19.9) followed by a 16.5% (5.9-42.3) median increase over the 6-month maintenance period phase. Previous intensive treatment was the only significant predictor of this response. As compared to baseline, heaviness limiting limb use was much less frequently reported at the end of the reductive phase (75.5% versus 42.3% respectively), and was more frequent at the end of the maintenance phase (62.6%). The most frequent adverse events reported were skin redness and compression marks (18.4 and 15.7% of patients, respectively). Blisters requiring treatment stoppage were rare (1.4%). CONCLUSIONS: Intensive phase decreases lymphedema volume and heaviness limiting limb function. The benefit is partially abolished after the first 6 months of maintenance. There is a need to consider how to provide optimal patient care for the long-term control of lymphedema.

Annual diagnosis rate of superficial vein thrombosis of the lower limbs: the STEPH community-based study.

BACKGROUND: The incidence of superficial vein thrombosis (SVT) in the general adult population remains unknown. OBJECTIVES: To assess the annual diagnosis rate of symptomatic, objectively confirmed lower limb SVT, associated or not with concomitant deep vein thrombosis and/or symptomatic pulmonary embolism. METHODS/PATIENTS: We conducted, from November 14, 2011, to November 13, 2012, a multicenter, community-based study in the Saint-Etienne urban area, France, representing a population of 265 687 adult residents (according to the 2009 census). All 248 general practitioners located within the area were asked to refer any patient with clinically suspected lower limb acute SVT to a vascular physician for systematic compression ultrasonography. All 28 vascular physicians located within the area participated in the study. The annual diagnosis rate, with the corresponding 95% confidence interval (CI), was calculated as the number of patients with symptomatic, objectively confirmed SVT divided by the number of person-years at risk defined by population data of the area. All venous thromboembolic events were validated by an independent central adjudication committee. RESULTS: Overall, 171 patients with symptomatic, confirmed SVT were reported. The annual diagnosis rate was 0.64& (95% CI, 0.55%-0.74&), was higher in women, and increased with advancing age regardless of gender [corrected]. Concomitant deep vein thrombosis (20 proximal) was observed in 42 patients (24.6% [95% CI, 18.3%-31.7%]), and concomitant symptomatic pulmonary embolism was observed in eight patients (4.7% [95% CI, 2.0%-9.0%]). CONCLUSIONS: This first community-based study showed that symptomatic SVT with confirmed diagnosis is a relatively common disease frequently associated with thromboembolic events in the deep venous system.

Quality of life and functional outcome in early school-aged children after neonatal stroke: a prospective cohort study.

BACKGROUND: Quality of life (QoL) is recognized internationally as an efficient tool for evaluating health interventions. To our knowledge, QoL has not been specifically assessed in children after neonatal arterial ischemic stroke (AIS). AIM: To study the QoL of early school-aged children who suffered from neonatal AIS, and QoL correlation to functional outcome. METHOD: We conducted a multicenter prospective cohort study as part of a larger study in full-term newborns with symptomatic AIS. Participating families were sent anonymous QoL questionnaires (QUALIN). Functional outcome was measured using the Wee-FIM scale. Healthy controls in the same age range were recruited in public schools. Their primary caregivers filled in the QUALIN questionnaires anonymously. We used Student's t-test and a rank test to compare patients and controls' QoL and functional outcomes. RESULTS: 84 children with neonatal AIS were included. The control group was composed of 74 children, of which ten were later excluded due to chronic conditions. Mean ages and QUALIN median scores did not differ between patients and controls. Median Wee-FIM scores were lower in hemiplegic children than in non-hemiplegic ones (p < 0.001). QoL scores did not seem correlated to functional outcome. INTERPRETATION: Those results could support the presence of a "disability paradox" in young children following neonatal AIS.

Inter-observer variability in sizing fenestrated and/or branched aortic stent-grafts.

BACKGROUND: Several studies have examined inter-observer variability in measurements for standard EVAR, but little is known about measurements for complex aortic aneurysm. METHODS: Two independent observers reviewed all preoperative CT scans of 268 patients in a French trial of fenestrated and/or branched aortic stent-grafts (f/b-EVAR). Those data were compared with those obtained (1) by investigators (extent of aneurysm, target vessel stenosis, and aortic diameters), and (2) from manufacturers (proximal landing zone, device diameter, and target vessel position). We assessed the reproducibility using kappa statistics for qualitative data and both Bland-Altman plot and Passing-Bablok regression analysis for quantitative data. RESULTS: Reproducibility was moderate to almost perfect for all factors. However, a few critical discrepancies were found, such as target vessel clock position (≥45 minutes) and location (≥5 mm), level of proximal landing zone, and diameters of the endograft. CONCLUSIONS: This is the first large-scale analysis focused on inter-observer variability in sizing for f/b-EVAR. The measurement data showed good agreement, but there were some critical discrepancies between observers that may affect clinical results.

Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies.

BACKGROUND: The management strategies for symptomatic isolated superficial vein thrombosis (SVT) (without concomitant deep vein thrombosis [DVT] or pulmonary embolism [PE]) have yet to achieve widespread consensus. Concerns have been raised regarding the usefulness of prescribing anticoagulant treatments to all patients with isolated SVT. Determining the isolated SVT subgroups who have the highest risks of venous thromboembolism (VTE) recurrence (composite of DVT, PE, and new SVT) may facilitate the identification of patients who are likely to benefit from anticoagulant treatment. DESIGN AND METHODS: We performed a pooled analysis on individual data from two observational, multicenter, prospective studies, to determine predictors for VTE recurrence and their impact in an unselected population of symptomatic isolated SVT patients. RESULTS: One thousand and seventy-four cases of symptomatic isolated SVT were followed up at 3 months. VTE recurrence was observed in 3.9% of the patients; 16.2% of the patients did not receive anticoagulants, and 0.6% experienced a VTE recurrence. Cancer, personal history of VTE and saphenofemoral/popliteal involvement significantly increased the risk of subsequent VTE or DVT/PE in univariate analyses. Only male sex significantly increased the risk of VTE or DVT/PE recurrence in multivariate analyses. Twelve percent of the patients had cancer or saphenofemoral junction involvement, and were at higher risk of DVT/PE recurrence than patients without those characteristics (4.7% vs. 1.9%, P= 0.06). CONCLUSIONS: In patients with symptomatic SVT, only male sex significantly and independently increased the risk of VTE recurrence. Cancer or saphenofemoral junction involvement defined a population at high risk for deep VTE recurrence. Some SVTs might be safely managed without anticoagulants.

Value of TENS for relief of chronic low back pain with or without radicular pain.

OBJECTIVES: To evaluate the efficacy of transcutaneous electrical neurostimulation (TENS) in patients with chronic low back pain (LBP). DESIGN: Prospective, randomized, multicentre, single-blind study. SETTING: Twenty-one French pain centres. PARTICIPANTS: Two hundred thirty-six consecutive adult patients consulting for chronic LBP, with or without radicular pain (mean age ± standard deviation: 53 ± 13 years; range: 28-86 years). INTERVENTION: Patients were randomly assigned to receive either active (n = 117) or sham (n = 119) TENS in four 1-h daily treatment sessions for 3 months. MAIN OUTCOME MEASURES: The primary outcome measured was improvement of functional status at 6 weeks (Roland-Morris Disability Questionnaire). Secondary outcome measures were improvement of functional status at 3 months, pain relief (weekly visual analogue scale assessments), positive functional repercussions of pain levels on quality of life, a diminution of the use of analgesic and anti-inflammatory medication, satisfaction with the overall treatment strategy and compliance. RESULTS: Functional status did not differ between the groups, whether at 6 weeks or 3 months (p = 0.351 at 6 weeks). A significant improvement between the first and last visual analogue scale assessments was observed in patients with either lumbar pain alone or lumbar and radicular pain treated with active TENS. Other outcome measures did not differ significantly between the two groups. CONCLUSION: There was no functional benefit of TENS in the treatment of patients with chronic LBP.

Paediatric moyamoya in mainland France: a comprehensive survey of academic neuropaediatric centres.

BACKGROUND: Epidemiological data of paediatric moyamoya disease/syndrome (MMD/MMS) in non-Asian populations are scarce. METHODS: A questionnaire was sent to every French neuropaediatric academic centre to estimate the prevalence, incidence, familial form rate and location of paediatric MMD/MMS cases. Specific paediatric data were also retrieved from the most recent nationwide Japanese study. RESULTS: A 100% response rate was obtained. The prevalence of paediatric MMD/MMS was estimated at 0.39/100,000 children (95% CI: 0.28-0.49), and the incidence was estimated at 0.065/100,000 children/year (95% CI: 0.025-0.12), with 7.5% familial cases. The prevalence was homogenous within the different administrative areas. CONCLUSIONS: This comprehensive survey of MMD/MMS in academic neuropaediatric centres suggests that the prevalence of the disease in children in France is approximately 1/20th of that estimated in Asia.

Neurological outcome and risk of recurrence depending on the anterior vs. posterior arterial distribution in children with stroke.

We report the outcome of 46 previously healthy children with arterial ischemic stroke. After a mean follow-up of 26 months, five (11%) children suffered a recurrence and 28 (61%) were left with sequelae. The prevalence and the severity of the sequelae were similar irrespective of whether the localization of the accident was anterior or posterior. However, a recurrence was significantly more frequent in the posterior than in the anterior group (4/14 vs. 1/32; p=0.025). These observations may lead to the establishment of therapeutic guidelines according to the localization of the infarct.

[Impact of frailty factors in elderly people older than 75 years with prosthesis of the hip]. / Impact des facteurs de fragilité sur le devenir des sujets âgés de 75 ans et plus opérés d'une prothèse de hanche.

OBJECTIVE: Hip pathology of hip requiring a surgical assumption of responsibility (coxarthrose invalidating, hip fracture) is increasing, and after the year 2025, the number of interventions will double. In parallel, the number of elderly people (older than 75 years) with malnutrition associated with cognitive impairment and reduced autonomy is on the increase. So the concept of frail elderly identified by specific criteria allows for better defining the health needs of heterogeneous elderly people. The objective of this study was to determine the influence of frailty factors on autonomy and clinical outcome after intervention for prosthesis of the hip. METHODOLOGY: This prospective work, completed over 8 months, included 55 patients with total or intermediate prostheses of hip, whatever the cause, recruited from rehabilitation wards. Results from a pre-established questionnaire defined the personal status and social framework of these patients. A medical examination evaluated cognitive function Mini Mental State (MMS), nutritional state (IMC) and the level of autonomy immediately after surgery (the first 2 weeks) by the measurement of functional independence (MIF). The second MIF was carried out by the same operator at the end of the assumption of responsibility by the institution. RESULTS: Three factors of frailty influenced progress at the time of reacquisition of autonomy: cognitive impairment (P < 0001; 1 patient out of 2 [50%] had an MMS score < 22); reduced nutrition? (P < 0.0026; [29% had a BMI score < 20 or a perimeter of the calf < 30 cm]; and accommodations before the intervention (P < 0.028; [15% lived in an institution]). CONCLUSION: Nutritional state, cognitive level and social activity must be evaluated regularly in elderly subjects with hip prosthesis to evaluate optimal load and adaptation.