FIRE Stones: impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser-protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation.

BACKGROUND: Lithiasis is a common and recurrent disease. Flexible ureteroscopy (fURS) is the cornerstone of laser treatment of kidney stones. Kidney stones destruction requires its laser pulverization into small fragments in order to remove them through the ureter or improve their spontaneous expulsion along the urinary tract. However, most of the time, all the micro-fragments and dust created cannot be extracted using our surgical tools and may stay intra-renally at the end of the procedure. Adjuvant treatments (such as forced diuresis, inversion or mechanical pressure) were previously described to improve the expulsion of stone fragments after extra-corporeal shock wave lithotripsy. Nevertheless, the impact of adjuvant treatment after fURS remains unclear and mainly theoretical. OBJECTIVE: The primary objective is to show that the injection of 40 mg of furosemide in slow intravenous during 10 min, after the procedure, increases the stone-free rate 3 months after a fURS for destruction of kidney stones with laser. METHODS/DESIGN: The study will be a two-parallel group randomized, controlled, multicentric trial with a blinding evaluation. Nine French departments of urology will participate. Patients will be randomized in 2 groups: the experimental group (injection of 40 mg of furosemide at the end of the surgery) and a control one (usual care). Patients will be followed up for 3 months (± 2 weeks) after the surgery. Then, we will perform a low dose abdomino-pelvic CT scan. The primary outcome is the stone-free rate at 3 months. A centralized review of the images will be performed by two specialized radiologists, in a blind and crossed way to allow a homogenization of the results. The secondary outcomes will include the rate of early post-operative urinary tract infection (UTI), the evaluation of post-operative pain, and the safety of the use of furosemide in patients treated by fURS for renal stone laser destruction. As secondary objectives, it is also planned to look at the effect of the prescription of an alpha-blocker as usual treatment on stone-free rate and to assess the agreement between the imaging analysis of the urologist and the specialized radiologist. DISCUSSION: Lithiasis is a public health problem. It affects about 10% of the general population. This prevalence is increasing (multiplied by 3 in 40 years), partly due to changes in the population's eating habits over the years. The lithiasis patient is a patient with a chronic disease requiring annual follow-up and who may suffer from multiple recurrences, with a recurrence rate at 5 years of 50%. Recurrences are partly due to residual fragments left in the kidneys at the end of the operation. Other risk factors for recurrence include dietary hygiene and the presence of an associated metabolic disease. The metabolic blood and urine tests recommended by the Association Française d'Urologie (AFU) can be used to manage these last two problems. As far as residual fragments are concerned, their presence leads to an early recurrence of stones because they form the bed for a new aggregation of crystals in the kidneys. Being able to reduce the rate of residual fragments in patients with the use of furosemide at the end of the intervention therefore seems essential in the management of recurrences in our patients. This will also improve our patients' quality of life. Indeed, lithiasis disease leads to chronic pain associated with acute pain that motivates consultations to the emergency for specialized management. This study is the first to evaluate the impact of forced diuresis with the use of furosemide on the stone-free rate after a fURS for destruction of kidney stone with laser. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05916963 , first received: 22 June 2023. EU Clinical Trials Register EudraCT Number: 2022-502890-40-00.

Topical sirolimus solution for lingual microcystic lymphatic malformations in children and adults (TOPGUN): study protocol for a multicenter, randomized, assessor-blinded, controlled, stepped-wedge clinical trial.

BACKGROUND: Lingual microcystic lymphatic malformations (LMLMs) are rare congenital vascular malformations presenting as clusters of cysts filled with lymph fluid or blood. Even small well-limited lesions can be responsible for a heavy burden, inducing pain, aesthetic prejudice, or oozing, bleeding, infections. The natural history of LMLMs is progressive worsening punctuated by acute flares. Therapeutic options include surgery, laser excision, and radiofrequency ablation but all are potentially detrimental and expose to local relapse. Therefore, the management frequently relies on a "watchful waiting" approach. In complicated LMLMs, treatment with oral sirolimus, a mammalian target of rapamycin (mTOR) inhibitor, is often used. Topical applications of sirolimus on the buccal mucosae have been reported in other oral diseases with good tolerance and none to slight detectable blood sirolimus concentrations. We aim to evaluate the efficacy and safety of a 1 mg/mL sirolimus solution applied once daily on LMLM of any stage in children and adults after 4, 8, 12, 16, 20, and 24 weeks of treatment compared to usual care (no treatment). METHODS: This is a randomized, multicentric study using an individually randomized stepped-wedge design over 24 weeks to evaluate topical application of a 1 mg/mL sirolimus solution once daily, on LMLM, versus usual care (no treatment), the control condition. Participants begin with an observational period and later switch to the intervention at a randomized time (week 0, 4, 8, or 12). Visits occur every 4 weeks, either in the study center or by teleconsulting. The primary outcome will be the evaluation of global severity of the LMLM on monthly standardized photographs by 3 independent blinded experts using the physical global assessment (PGA) 0 to 5 scale. Secondary outcomes will include lesion size measurement and quality of life assessment, investigator, and patient-assessed global disease and specific symptoms (oozing, bleeding, sialorrhea, eating impairment, taste modification, aesthetic impairment, pain, and global discomfort) assessment. A biological monitoring will be performed including residual blood sirolimus concentration and usual laboratory parameters. DISCUSSION: Given the disappointing state of current treatment options in LMLMs, topical sirolimus could become firstline therapy in treating LMLMs if its efficacy and safety were to be demonstrated. TRIAL REGISTRATION: ClinicalTrials.gov NCT04128722 . Registered on 24 September 2019. EudraCT: EUCTR2019-001530-33-FR Sponsor (University Hospital Center of Tours - CHRU Tours): DR190041-TOPGUN French regulatory authorities: ID RCB: 2019-001530-33.

Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial.

BACKGROUND: Cervical cancer screening coverage remains insufficient in most countries. Our objective was to assess whether in-home vaginal self-sampling with a dry swab for high-risk human papillomavirus (HR-HPV) testing is effective and cost-effective in increasing participation in cervical cancer screening. METHODS: In March 2012, 6000 unscreened women aged 30-65 years, living in a French region covered by a screening programme, who had not responded to an initial invitation to have a Pap smear were equally randomised to three groups: 'no intervention'; 'recall', women received a letter to have a Pap smear; and 'self-sampling', women received a self-sampling kit to return to a centralised virology laboratory for PCR-based HPV testing. RESULTS: Participation was higher in the 'self-sampling' than in the 'no intervention' group (22.5% vs 9.9%, P<0.0001; OR 2.64) and 'recall' group (11.7%, P<0.0001; OR 2.20). In the 'self-sampling' group, 320 used the self-sampling kit; for 44 of these women with positive HR-HPV test results, 40 had the recommended triage Pap smear. The ICER per extra screened woman was 77.8[euro ] and 63.2[euro ] for the 'recall' and 'self-sampling' groups, respectively, relative to the 'no intervention' group. CONCLUSIONS: Offering an in-home, return-mail kit for vaginal self-sampling with a dry swab is more effective and cost-effective than a recall letter in increasing participation in cervical cancer screening.

Accuracy of dry vaginal self-sampling for detecting high-risk human papillomavirus infection in cervical cancer screening: a cross-sectional study.

OBJECTIVE: Cervical cancer screening coverage remains insufficient in most countries. Testing self-collected samples for high-risk human papillomavirus (HR-HPV) could be an alternative to the Pap smear, but costs, sampling methods and transport issues hamper its wide use. Our objective was to compare diagnostic accuracy of 2 vaginal self-collection methods, a dry swab (vsc-DRY) or swab in liquid medium (vsc-LIQ), for detecting HR-HPV cervical infection assessed by a cervical clinician-collected sample in liquid medium (ccc-LIQ). METHODS: Women 20 to 65 years attending a Pap smear were recruited between September, 2009 and March, 2011. Each sample (3 per woman) underwent HPV DNA testing. Samples were classified as HR-HPV+ with detection of at least one HR-HPV or probable HR-HPV type. RESULTS: Of 734 women included, 722 had complete HPV data. HR-HPV was detected in 20.9% of ccc-LIQ samples. Estimated sensitivity and specificity to detect HR-HPV in vsc-DRY samples were 88.7% and 92.5%, respectively, and in vsc-LIQ samples, 87.4% and 90.9%. Cytology findings were abnormal for 79 women (10.9%): among 27 samples of low-grade squamous intraepithelial lesions, 25 were HR-HPV+ in vsc-DRY, vsc-LIQ and ccc-LIQ samples. Among 6 samples of high-grade squamous intraepithelial lesions, all were HR-HPV+ in vsc-DRY samples, 1 was HR-HPV- in vsc-LIQ samples and 1 was HR-HPV- in ccc-LIQ samples. CONCLUSIONS: Vaginal self-sampling with a dry swab is accurate to detect HR-HPV infection as compared with cervical clinician-collection and accurate as compared with cytology results. This cheap and easy-to-ship sampling method could be widely used in a cervical cancer screening program.

Heterogeneity in meta-analyses of treatment of acute postoperative pain: a review.

BACKGROUND: Heterogeneity and its causes must be assessed using meta-analyses (meta-analysis). Especially in meta-analysis dealing with treatment of acute postoperative pain, the type of surgery is a source of heterogeneity. We aimed to assess whether the type of surgery is considered a source of heterogeneity in meta-analysis and how it is taken into account in meta-analysis evaluating the efficacy of treatment of acute postoperative pain. We further compared meta-analysis that pooled trials of surgeries with highly heterogeneous postoperative pain levels, the heterogeneous group, with meta-analysis that pooled trials involving surgeries with homogeneous pain levels, the homogenous group. METHODS: The meta-analysis reports available in Issue 3, 2011 of the electronic database of the Cochrane library and pooling results of randomized or quasi-randomized controlled trials that assessed the efficacy of treatment of acute postoperative pain alone were considered. A survey of experts established a rating of the postoperative pain levels for the type of surgery. For each meta-analysis, the different pain level ratings associated with the trials included in the meta-analysis were considered and the standard deviation (sd) of these ratings calculated. From the distribution of sd values, we defined the heterogeneous and homogeneous groups. RESULTS: Sixty-one meta-analyses were included; all assessed heterogeneity. Twenty-six meta-analyses considered the type of surgery as a subgroup (50% vs 38% in the homogeneous group vs heterogeneous group). Forty-four reports discussed the type of surgery as a source of clinical heterogeneity (85% vs 62% for the homogeneous vs heterogeneous group). Twenty-nine meta-analyses compared 'postoperative pain from dental surgery' to 'other type of surgery'. CONCLUSIONS: Meta-analyses evaluating treatment of postoperative pain should explore clinical heterogeneity associated with the type of surgery for better implications for practice.

Improving outcome of chemotherapy of metastatic breast cancer by docosahexaenoic acid: a phase II trial.

BACKGROUND: Breast cancer becomes lethal when visceral metastases develop. At this stage, anti-cancer treatments aim at relieving symptoms and delaying death without resulting in additional toxicity. On the basis of their differential anti-oxidant defence level, tumour cells can be made more sensitive to chemotherapy than non-tumour cells when membrane lipids are enriched with docosahexaenoic acid (DHA), a peroxidisable and oxidative-stress-inducing lipid of marine origin. METHODS: This open-label single-arm phase II study evaluated the safety and efficacy (response rate), as primary end points, of the addition of 1.8 g DHA daily to an anthracycline-based chemotherapy (FEC) regimen in breast cancer patients (n = 25) with rapidly progressing visceral metastases. The secondary end points were time to progression (TTP) and overall survival (OS). RESULTS: The objective response rate was 44%. With a mean follow-up time of 31 months (range 2-96 months), the median TTP was 6 months. Median OS was 22 months and reached 34 months in the sub-population of patients (n = 12) with the highest plasma DHA incorporation. The most common grade 3 or 4 toxicity was neutropaenia (80%). CONCLUSION: DHA during chemotherapy was devoid of adverse side effects and can improve the outcome of chemotherapy when highly incorporated. DHA has a potential to specifically chemosensitise tumours.

[Real-time contrast-enhanced ultrasound in the evaluation of focal liver lesions: diagnostic efficacy and economical issues from a French multicentric study]. / Echographie de contraste temps réel dans la prise en charge diagnostique des lésions nodulaires hépatiques: évaluation des performances diagnostiques et de l'impact économique sur une étude multicentrique française.

The recent introduction of high-end ultrasound equipment combined with recent contrast agents provides marked improvements in the characterization of focal liver lesions as previously reported by monocentric studies. The aim of the present study was to evaluate the diagnostic performance of Contrast-Enhanced Ultrasonography (CEUS) using SonoVue as well as its medico-economic value for characterization of focal liver lesions. These nodules were not characterized on previous CT or conventional sonography. This prospective multicentric study conducted in 15 French centres found diagnostic performances similar to those reported for CT and MRI, with a concordance rate of 84.5%, sensitivity greater than 80% and specificity greater than 90% for all types of lesions. Higher acceptance was found for CEUS compared to other imaging modalities. Economical assessment based on examination reimbursment and contrast agent cost showed a lower cost for contrast ultrasound versus CT and MRI. This French multicentric study confirmed the high diagnostic value of CEUS for focal liver lesion characterization and demonstrated a lower economical impact compared to other imaging modalities such as CT and MRI.

[Power Doppler Index for preoperative ovarian tumors discrimination]. / Valeur de l'index de vascularisation (Power Doppler Index) pour la discrimination des masses ovariennes en préopératoire.

OBJECTIVE: To assess the performance of a power doppler vascularity index in the preoperative diagnosis of ovarian malignancy. PATIENTS AND METHODS: Two successive series of adnexal masses (N=101 and N=82) were examined prospectively with power Doppler before surgical treatment. A vascularity index, called Power Doppler Index (PDI), based on the number of colored pixels, was estimated on selected frames (defined region of interest covering the entire tumor) of the tumors using an in house color-quantifying program. The first study was monocentric to test the inter- and intraobserver reproducibilities and the availability of the parameter. The second was multicentric to validate the first results. The sensitivity and specificity of PDI, resistance index (RI) and subjective visual scoring were compared using receiver operating characteristic (ROC) curves. RESULTS: Histology identified 23 malignant and 78 benign lesions in the first study and 34 malignant and 48 benign tumors in the second. PDI was considerably higher in malignant than in benign lesions (0.34+/-0.04 vs 0.12+/-0.06 (P<0.001)). Intra-observer and interobserver variability of PDI was low (intraclass correlation coefficients estimated at 0.99 and 0.98, respectively). The PDI cut-off value for differential diagnosis was set at 0.265 (26.5% of the tumor is colored) in the first study and 0.107 in the second. Sensitivity and specificity were 100% (95% CI [87.8; 100.0]) and 97.4% (95% CI [91.0; 99.7]), respectively, for PDI in the first study compared to 75% (95% CI [72.9; 90.7]) and 60% (95% CI [56.3; 92.5]) in the second study. Using logistic regression, visual Doppler scoring performed best. DISCUSSION AND CONCLUSION: The Power Doppler Index obtained using our color quantifying software has discriminating power for adnexal masses but visual Doppler scoring performs best.

The genotype 3-specific hepatitis C virus core protein residue phenylalanine 164 increases steatosis in an in vitro cellular model.

BACKGROUND AND AIMS: The prevalence and severity of liver steatosis are higher in patients infected with genotype 3 hepatitis C virus (HCV) than in patients infected with other genotypes. HCV core protein is known to affect lipid metabolism, inducing lipid droplet accumulation both in vitro and in vivo. An in vitro cellular model was used to investigate whether an HCV core protein with residues specific to genotype 3 increased this phenomenon. METHODS: Sequence comparisons for HCV core protein domain II, which is known to interact with lipid droplets, identified the phenylalanine (F) residue at position 164 as the only residue specific to genotype 3. The area covered by lipid droplets in sections of cells producing a wild-type genotype 1a HCV core protein was compared with that in cells producing a Y164F mutant protein. RESULTS: Cumulative lipid droplet area was significantly greater in sections of cells producing the Y164F mutant HCV core protein than in cells producing the wild-type protein (p<0.001). The frequency of cell sections containing more than 3 mum(2) of lipid droplets, in particular, was higher for the mutant than for the wild-type protein. CONCLUSION: The data provide a molecular explanation for HCV genotype 3-specific lipid accumulation. This difference between genotypes may be due to phenylalanine having a higher affinity for lipids than tyrosine (Y). These observations provide useful information for further studies of the mechanisms involved in HCV-induced steatosis.

Factors influencing laparoconversions during the learning curve of laparoscopic myomectomy.

BACKGROUND: To assess the probability of conversion of a laparoscopic myomectomy to an open procedure, we only found the score developed by Dubuisson et al. (2001) based on four preoperative risk factors. Routinely this score is not appropriate, as realized by the most skilled laparoscopic surgeons. METHODS: The aim of this study was to identify the preoperative factors affecting the risk of conversion in data collected in different centers among a population of surgeons at the beginning of their experience in laparoscopic myomectomy. We collected preoperative clinical and ultrasonography data for all laparoscopic myomectomies performed in 11 hospital centers between January 1996 and December 2000. Data were available for 116 patients. Multiple logistic regression was use to develop a simple predictive model based on available preoperative risk factors of laparoconversion. RESULTS: We encountered 33 laparoconversions (28%) compared to an expected number of 7.8 using Dubuisson's score. We confirmed the importance of two of the four risk factors in Dubuisson's model: biggest myoma size at ultrasonography (increased 1 mm) (OR: 1.06) and intramural type (OR: 3.25) of the dominant myoma. However, we also identified another risk factors: surgeon's experience (OR: 0.15). Simple score was calculated and used to provide an estimated risk of conversion. CONCLUSION: Our model is a useful tool to predict laparoconversion for surgeons beginning in laparoscopic myomectomy. Ultrasound evaluation is essential before performing the procedure. Skilled surgeons in laparoscopy and in laparoscopic myomectomy must help their trainees during their learning curve in order to reduce laparoconversion rate.

Power Doppler vascularity index for predicting malignancy of adnexal masses.

OBJECTIVE: To assess the performance of a power Doppler vascularity index in the preoperative diagnosis of ovarian malignancy. METHODS: Adnexal masses (n = 101) were examined prospectively with power Doppler ultrasonography before surgical treatment. The tumor vascularity index (power Doppler index, PDI) was determined by quantification of the number of pixels in a defined region of interest according to the formula: number of colored pixels/(total number of pixels minus the number of pixels in the fluid or avascular areas). It was estimated on selected frames of the tumors using an in-house color-quantifying program added to MATLAB 6.0 software. Inter- and intraobserver reproducibilities of PDI assessment were evaluated. Intratumoral blood flow velocity waveforms were obtained to determine the lowest resistance index (RI). A subjective visual score of power Doppler signals in the tumor was used to classify it as having low, moderate or high vascularity. The discriminatory ability of this score was compared to that of RI and PDI measurement. RESULTS: Histology identified 23 malignant and 78 benign lesions. The PDI was considerably higher in malignant than in benign lesions (0.34 +/- 0.04 vs. 0.12 +/- 0.06; P < 0.001). The intra- and interobserver variabilities of PDI were low (intraclass correlation coefficients of 0.99 and 0.97, respectively). The PDI cut-off value to differentiate malignant from benign tumors was set at 0.265 (26.5% of the tumor being colored). Using this cut-off, sensitivity and specificity were 100% (95% CI, 87.8-100.0) and 97.4% (95% CI, 91.0-99.7) compared to 78.3% (95% CI, 56.3-92.5) and 83.1% (95% CI, 72.9-90.7) for RI (cut-off value of 0.53) and 78.3% (95% CI, 56.3-92.5) and 94.9% (95% CI, 87.4-98.6) for visual scoring. Logistic regression demonstrated that PDI was the best parameter for differentiating between malignant and benign tumors. CONCLUSION: The power Doppler vascularity index obtained using customized color quantifying software has high diagnostic value in discriminating between benign and malignant adnexal masses.

Is ultrasound lymph node examination superior to clinical examination in melanoma follow-up? A monocentre cohort study of 373 patients.

BACKGROUND: There is still lack of consensus regarding the most effective follow-up for stage I and II melanoma patients although some consensus conferences have provided guidelines stating that clinical examination should be the standard. OBJECTIVES: Our aim was to study the value of adding ultrasound lymph node examination (7.5 MHz) to the routine clinical examination recommended by French guidelines in melanoma follow-up. METHODS: A cohort of melanoma patients was enrolled between 1 July 1995 and 1 July 2000 in a follow-up protocol including clinical examination performed four times a year for thick melanomas (Breslow index > or = 1.5 mm) and twice a year for thin melanomas (Breslow index < 1.5 mm) according to French guidelines, and ultrasound lymph node examination performed every 6 months for thick melanomas and every year for thin melanomas. Follow-up was continued up to 1 July 2003. When clinical or ultrasound examination indicated signs of node recurrence, surgical biopsy of the involved node was performed. When ultrasound examination was only suspicious, another ultrasound examination was performed within the following 3 months. The results of both clinical and ultrasound examinations were compared with histopathology examination when node biopsy was performed. RESULTS: Ultrasound follow-up was performed for 373 patients (213 females and 160 males). Mean age at diagnosis of melanoma was 59 years (range 14-90, SD 15). In total, 1909 ultrasound examinations combined with clinical examination were analysed. Node biopsy was performed in 65 patients and demonstrated melanoma metastases in 54. Sensitivity of clinical examination and ultrasound examination was 71.4%[95% confidence interval (CI) 55.4-84.3] and 92.9 (95% CI 80.5-98.5), respectively, P = 0.02. Specificity of clinical examination and ultrasound examination was 99.6% (95% CI 99.2-99.8) and 97.8% (95% CI 97.0-98.4), respectively. Despite this apparent superiority of ultrasound examination over palpation, only 7.2% of the patients really benefited from ultrasound examination (earlier lymph node metastasis detection or avoidance of unnecessary surgery), while 5.9% had some deleterious effect from ultrasound examination (unnecessary stress caused by repetition of ultrasound examination for benign lymph nodes, useless removal of benign lymph node). CONCLUSIONS: This study confirms the greater sensitivity of ultrasound examination to clinical examination in the diagnosis of node metastases from cutaneous melanoma. However, the place of ultrasound in routine follow-up is at least questionable as only a very small proportion of patients (1.3%) really benefited from adding ultrasound examination to clinical examination.

[Lymphedema of the limb: predictors of efficacy of combined physical therapy]. / Lymphoedème de membre. Critères prédictifs de l'efficacité du traitement physique combiné.

BACKGROUND: Limb lymphedema results from incompetence of the lymphatic system, and treatment of both primary and secondary forms involves manual lymphatic drainage and support. The effectiveness of treatment varies from patient to patient and can be unpredictable. OBJECTIVE: To investigate clinical and paraclinical criteria able to predict responses to combined physical treatment (lymphatic drainage and multilayered support) during hospitalization. PATIENTS AND METHODS: A retrospective study was performed in 45 patients admitted for one week's intensive treatment of limb lymphedema in the Lymphology Unit of the Department of Dermatology of the University Hospital of Tours. Lymphoscintigraphy was performed for all patients on admission. Loss of volume in affected limbs was studied to evaluate the effectiveness of treatment. RESULTS: Two criteria were predictive of resistance to combined treatment, i.e. venous insufficiency and continuing lymph node evidence of scintigraphic activity four hours after lymphoscintigraphy. The two factors were significantly related. CONCLUSION: Failure of combined physical treatment for lymphedema appears to be related to venous insufficiency. It is therefore essential to investigate and treat venous insufficiency, particularly in patients with continuing evidence of scintigraphic activity in lymph nodes.

Epidural corticosteroid injections for sciatica: a randomised, double blind, controlled clinical trial.

OBJECTIVE: To determine the efficacy of epidural corticosteroid injections for sciatica. METHODS: Three epidural injections (two day intervals) of 2 ml prednisolone acetate (50 mg) or 2 ml isotonic saline were administered to patients with sciatica presumably due to a disk herniation lasting 15-180 days. Self evaluation was the main judgment criterion at day 20. Patients who recovered or showed marked improvement were considered as success. Pain measured by VAS, the SLR test, Schober's test, Dallas pain questionnaire, and the Roland-Morris index were evaluated at days 0, 5, 20, and 35. Only analgesics were authorised, patients requiring non-steroidal anti-inflammatory drugs (NSAIDs) before day 20 were considered as failure. RESULTS: 42 patients were included in the control group (CG), 43 in the steroid group (SG). On an intention to treat analysis 15/42 (36%) in the CG and 22/43 (51%) in the SG (p=0.15) were considered as success (difference 15.5%, 95% CI (-5.4 to 36.3)). Among the 48 failures, 14 patients (6 CG, 8 SG) required NSAIDs, 3 (2 CG, 1 SG) required surgery, and 7 (3 CG, 4 SG) other treatments. On analysis according to protocol, in 74 remaining patients 12/35 (34%) in the CG and 22/39 (56%) in the SG (p=0.057) were considered as success (difference 22.1%, 95% CI (0.0 to 44.2)). For all secondary end points intragroup improvement with time was significant, but intergroup differences were not. CONCLUSION: The efficacy of isotonic saline administered epidurally for sciatica cannot be excluded, but epidural steroid injections provide no additional improvement.

Color Doppler energy prediction of malignancy in adnexal masses using logistic regression models.

OBJECTIVE: The aim of this study was to assess the usefulness of color Doppler energy in the preoperative diagnosis of ovarian malignancy using multivariate logistic regression analysis. METHODS: One hundred and thirty adnexal masses were studied with transvaginal B-mode, color energy, and pulsed Doppler ultrasonography before surgery in order to develop a model that could be used to determine malignancy. Each ultrasonographic variable (tumor size, wall thickness, septal structure, echogenicity, papillary projection, density (solid or not)) was included individually or combined together as part of the Sassone ultrasound score. Intratumoral blood flow velocity waveforms were obtained to determine pulsatility index and resistance index and a more subjective parameter, location of tumor vascularity, was also assessed. Menopausal status and serum CA 125 levels were also entered as categorical variables. Sonographic parameters were entered alone, then associated with menopausal status and CA 125 serum levels, and finally with Doppler energy measurements. Our model was then validated in a group of 68 adnexal masses and compared to the model of Alcazar. RESULTS: Eighteen adnexal masses (13.8%) were malignant or of low malignant potential. Multivariate analysis showed that papillary projection of the tumor wall, cyst with solid parts, resistance index with a cut-off value of 0.53, CA 125, and central blood flow location, were the only factors to be independent predictors of malignancy. Menopausal status was not an independent factor. For the final model including the Doppler energy parameter the best sensitivity and specificity were 83% and 93%, respectively, at a cut-off value of 10% probability of malignancy compared to 83% and 87% for the morphological variables alone. Validation of the model showed its diagnostic performance to be as good as that reported in the original population and better than the model of Alcazar. CONCLUSION: Sonographic analysis of adnexal masses including color Doppler energy shows the best predictive properties according to histological diagnosis, and improves preoperative diagnosis of malignancy.

[Morbidity and mortality of acute pancreatitis. Prospective study in a French university hospital]. / Morbidité et mortalité de la pancréatite aiguë. Evaluation prospective dans un centre hospitalier universitaire français.

OBJECTIVE: According to certain learned societies, acute pancreatitis mortality should not exceed 10%. The aim of our work was to review the etiology, severity and mortality of acute pancreatitis in a prospective series of patients admitted to a regional university hospital in France, using standardised collection of data assessing the medico-surgical habits in the management of acute pancreatitis. METHODS: From February to September 1999, 86 patients (54 men and 32 women with a mean age of 58.5 years) were admitted for 88 episodes of acute pancreatitis. Data was collected from all the patients on admission and permitted measurement of the severity and prognosis scores and the study of the etiology, complications and management of the latter and the mortality with acute pancreatitis. RESULTS: Ranson's score was a mean of 2.4. Balthazar's score was superior or equal to D in 45% of cases. The respective prevalence of lithiasis, alcoholism, tumors, others or undetermined was of 41%, 37.5%, 7%, 5.5% and 9%. Acute pancreatitis was severe (multi organ failure, pseudo-cyst, systemic or necrotic infection and occlusive syndrome) in 32% of cases. Complications were: infection (22%), pseudo-cyst (14%), pleural effusion (12.5%) and occlusive syndrome (3.5%). Fever of more than 38.5 degrees C was noted in more than half of the patients. The median duration of hospitalisation was of 11 days (range: 1-86 days). Global hospital mortality was of 13.6% (12/88), and of 43% (12/28) in cases of severe acute pancreatitis. Six deaths occurred within the first 8 days of acute pancreatitis, and 6 after 8 days. Seven deaths (59%) were due to multi organ failure, 4 (33%) to infectious causes and one to another cause. CONCLUSION: The standardized collection of clinical and progressive data used in this study permitted assessment of the medico-surgical habits in a regional university hospital.

[Laparoscopic fundoplication for gastroesophageal reflux disease: retrospective study of functional results in 243 patients]. / Fundoplicature laparoscopique pour reflux gastro-oesophagien: étude rétrospective des résultats fonctionnels chez 243 patients.

STUDY AIM: The aim of this retrospective study was to evaluate the 38 month-results of laparoscopic fundoplication for gastroesophageal reflux disease (GERD). PATIENTS AND METHODS: Two hundred forty three consecutive patients were operated laparoscopically. The surgical procedures were complete fundoplication with division of short vessels (Nissen: 80 patients), without division of short vessels (Nissen-Rossetti: 68 patients) or partial fundoplication of 270 degrees (Toupet: 95 patients). The mean follow-up was 38 months. Functional results were evaluated in 225 patients (92.5%) using a questionnaire with visual analog scales. RESULTS: The morbidity rate was 5%, higher after Nissen procedure (6.5%). With a follow-up of 3 months: a dysphagia coted 5/10, a gas bloat syndrome coted 4/10 and colon distension present in 61% of patients, were significantly more frequent after Nissen procedure. GERD recurred early in 4.5% of patients. With a follow-up of 38 months: dysphagia rate (coted 1/10) was significantly higher after Nissen. Dysphagia still persisted in 8 patients (9%) after Nissen. Colon distension and flatulence were more present after Nissen fundoplication. GERD recurrence rate was 12%. Pyrosis was significantly higher after Toupet fundoplication. Continuous medical treatment was necessary in 19 patients (8%). The satisfaction of patients was coted 7.5/10 without difference between to the three types of fundoplication. CONCLUSION: The total laparoscopic fundoplication for GERD seems to be a safe and efficient operation. This procedure proves to be more effective than partial fundoplicature but with a grater morbidity. Whatever the type of fundoplicature, the satisfaction of patients was good.

Histologic multifocality is predictive of skin recurrences after conserving treatment of stage I and II breast cancers.

OBJECTIVE: To distinguish various types of local recurrence after conserving treatment of breast cancer and to evaluate their predictive value. MATERIALS AND METHODS: We first researched the pronostic factors after local recurrence and second evaluated the predictive factors of skin and inflammatory recurrences out of a series of 605 cases of stage I and stage II breast cancer of less than 4 cm in diameter that occurred after conserving treatment. RESULTS: Multivariate analysis revealed two major predictors of poor prognosis associated with recurrence: early appearance Hazard ratio 3.0 (1.28-7.00) (p = 0.011) and inflammatory or skin involvement Hazard ratio 3.38 (1.36-8.45) (p = 0.009). A local recurrence multiplied the relative risk for metastasis by 2.6. This result depended on the type of recurrence: when those with inflammatory and cutaneous types were excluded, local recurrence was no longer a poor prognostic factor. Patients who experienced primary invasive tumor with histologic multifocality have a 4.08 (1.44-11.59) (p < 0.004) times greater risk of developing cutaneous or inflammatory recurrences compared with patients who experienced breast cancer unique localization. CONCLUSION: As histologic multifocality is the only factor predictive of dark prognosis local breast cancer recurrences, aggressive therapy at the time of the primary treatment could be the therapeutic implications of such finding on the original tumor.

[Microalbuminuria in hypertensive, non-proteinuric renal transplant recipients: role of previous acute rejection episodes and sodium intake]. / Micro-albuminurie chez le transplanté rénal hypertendu non protéinurique: influence des antécédents de rejet aigu et de l'apport sodé.

UNLABELLED: Microalbuminuria (Malb: albuminuria: 30-299 mg/24 h) is associated with many cardiovascular parameters (high systolic (SAP) and diastolic (DAP) arterial pressure, total cholesterol, triglycerides, fasting glucose and body weight, low HDL-cholesterol) and may be a marker of cardiovascular and renal risk in the general population. Whether MAlb could be an integrated marker of cardiovascular and renal risk in transplant recipients is unknown. PATIENTS AND METHODS: 75 hypertensive non-proteinuric renal transplant recipients were selected. Antihypertensive medications were stopped for a month prior to the studies. MAlb (on a 24-hour urine collection), cyclosporine trough levels (CsA-L), fasting glucose and lipids were measured. SAP and DAP were determined with a semi-automatic device. RESULTS: 29 patients (12 W/17M) had normal levels of albuminuria (Nalb: albuminuria < 30 mg/24 h) and 46 had MAlb. As compared to Nalb patients, those with Malb were younger (M +/- SD: 44.3 +/- 13 vs 51.2 +/- 9.7 respectively, p = 0.009), had higher SAP (152 +/- 16 vs 146 +/- 15 mmHg, p = 0.09) et DAP (86 +/- 11 vs 81 +/- 10 mmHg, p = 0.01). No difference in smoking habits, serum creatinine (125 +/- 27 vs 119 +/- 28 mumol/L), total-, HDL- and LDL-cholesterol, triglycerides, fasting glucose, CsA-L (142 +/- 29 vs 144 +/- 26 ng/mL), 24 h-urine urea excretion was observed. History of acute rejection episodes (45.7% vs 17.2%, p = 0.01) was more frequent and 24-hour natriuresis (192 +/- 70 vs 152 +/- 79 mmol/24 h, p < 0.01) was higher in Malb than in Nalb. CONCLUSION: The determinants of microalbuminuria in renal transplant recipients are different from those found in the general population. History of acute rejection episodes was more frequent in renal transplant recipients with Malb than in those with NAlb despite similar renal function, suggesting that Malb may a marker of subclinical renal lesions due to immunological aggression. The relationship between natriuresis and Malb suggests that sodium intake modulates target-organ damage associated with hypertension.