Pasquale Mastrantonio

Laparoscopic surgery vs laparotomy for early stage endometrial cancer: long-term data of a randomized controlled trial.

OBJECTIVE The purpose of the study was to compare the long-term safety and efficacy of laparoscopic surgery and laparotomy approaches to early stage endometrial cancer. STUDY DESIGN This was a prospective long-term extension study of a randomized controlled study that included 84 patients with clinical stage I endometrial cancer (laparoscopic surgery group, 40 women; laparotomy group, 38 women). Safety and efficacy data were evaluated and analyzed by the intention-to-treat principle. RESULTS After a follow-up period of 78 months (interquartile range, 7; range, 19-84 months) and 79 months (interquartile range, 6; range, 22-84 months) for laparoscopic surgery and laparotomy groups, respectively, no difference in the cumulative recurrence rates (8/40 [20.0%] and 7/38 [18.4%]; P = .860) and deaths (7/40 [17.5%] and 6/38 [15.8%] patients; P = .839) was detected between groups. No significant differences in overall (P = .535) and disease-free (P = .512) survival were observed. CONCLUSION The laparoscopic surgery approach to early stage endometrial cancer is as safe and effective a procedure as the laparotomy approach.

Metformin reduces risk of ovarian hyperstimulation syndrome in patients with polycystic ovary syndrome during gonadotropin-stimulated in vitro fertilization cycles: a randomized, controlled trial

OBJECTIVE To test whether metformin administration reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovary syndrome (PCOS) who have been treated with gonadotropins for IVF. DESIGN Parallel, randomized, double-blind, placebo-controlled clinical trial. SETTING Academic departments, general hospital, and IVF centers. PATIENT(S) One hundred twenty patients with PCOS at high risk for OHSS. INTERVENTION(S) Gonadotropins ovarian stimulation for IVF and metformin (500 mg three times daily) or placebo tablets (three times daily). MAIN OUTCOME MEASURE(S) The primary end point of the current clinical trial was the rate of OHSS. Anthropometric and reproductive data were evaluated. RESULT(S) The total OHSS and cancellation rates were significantly reduced in patients treated with metformin. The relative risk for OHSS was of 0.28 (95% confidence interval, 0.11-0.67). With metformin the stimulation length and the total amount of gonadotropins used were significantly increased, whereas the peak E(2) levels were significantly reduced. CONCLUSION(S) In patients with PCOS who are at high risk for OHSS and who have been stimulated with gonadotropins for IVF cycles, metformin reduces the risk of OHSS by modulating the ovarian response to the stimulation. REGISTRATION ID NUMBER FROM CLINICALTRIALS.GOV: NCT01233206.

Minilaparoscopic ovarian drilling under local anesthesia in patients with polycystic ovary syndrome

OBJECTIVE To assess pain control in patients with polycystic ovary syndrome (PCOS) who are undergoing ovarian drilling during minilaparoscopy under local anesthesia and conscious sedation and to evaluate the efficacy of this protocol compared with the traditional approach in terms of operative and discharge times, subsequent ovulation, and pregnancy. DESIGN Prospective randomized study. SETTING University hospitals and private day-surgery unit. PATIENT(S) Sixty-two infertile women with PCOS. INTERVENTION(S) Group A underwent minilaparoscopic ovarian drilling under local anesthesia and conscious sedation. Group B (control group) was treated with traditional ovarian drilling by laparoscopy under general anesthesia. MAIN OUTCOME MEASURE(S) Intraoperative pain score in group A. Hormonal profile before and after surgery, operative and discharge times, postoperative analgesic requirements, and reproductive follow-up in both groups. RESULT(S) Group A showed a good intraoperative pain score. The hormonal profile after surgery did not differ between groups A and B. Operative times were also similar for both groups. The number of patients discharged within 2 hours after surgery was significantly higher in group A. The need for postoperative analgesics was significantly higher in group B. No statistically significant differences were noted between the groups in terms of pregnancy and ovulation rates. CONCLUSION(S) Intraoperative and postoperative local anesthesia plus conscious sedation allows outpatient bilateral ovarian drilling by minilaparoscopy to be performed without general anesthesia. The high pregnancy rates, the simplicity of the method, and the faster discharge time offer a new option for patients with PCOS who are resistant to clomiphene citrate. Moreover, ovarian cauterization can be performed simultaneously with a diagnostic minilaparoscopy and integrated into the infertility workup of these patients.

Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease : a prospective, parallel, open-label, two-year extension study

Objective:To evaluate long-term efficacy of risedronate in osteoporotic postmenopausal patients with inflammatory bowel disease (IBD). Design:A prospective, parallel, open-label, 2-year extension study of a randomized, double-blind, 1-year clinical trial. Eighty-one osteoporotic postmenopausal women with IBD were treated with risedronate (n = 40) or placebo (n = 41). Bone mineral density (BMD), biochemical bone turnover markers, and vertebral and nonvertebral fractures were assessed throughout the study. Data were analyzed using the intent-to-treat principle. Results:Significant (P < 0.05) differences were observed between risedronate and placebo groups at 1-, 2-, and 3-year follow-up visits in bone turnover markers and in lumbar spine, trochanter, and femoral neck BMD. In partcipants treated with risedronate, the percentage of changes from baseline in bone turnover markers and in lumbar spine, trochanter, and femoral neck BMD were significantly (P < 0.05) higher at 2- and 3-year follow-up in comparison with baseline and 1-year follow-up, with a significant (P < 0.05) difference between the 2- and 3-year follow-up visits. At the end of the study, the cumulative risk of vertebral and nonvertebral fractures was significantly (P < 0.05) lower in the risedronate group than in the placebo group. The relative risk for new vertebral fractures was 0.456 (95% CI: 0.134-1.559, P = 0.211) and 0.296 (95% CI: 0.121-0.721, P = 0.007) and was 0.209 (95% CI: 0.023-1.867, P = 0.161) and 0.137 (95% CI: 0.030-0.620, P = 0.010), respectively, for new nonvertebral fractures after 2 and 3 years of risedronate treatment. Conclusions:In postmenopausal osteoporotic women with IBD, long-term treatment with risedronate is effective in increasing BMD and reducing vertebral and nonvertebral fracture risk.

A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data

OBJECTIVE Single-incision mini-slings (SIMS) are new minimally invasive devices used for female stress urinary incontinence (SUI). To date, several SIMS are available, but few and uncontrolled comparative data have assessed their safety and feasibility. The aim of the present clinical study was to compare three different SIMS in an ambulatory setting. STUDY DESIGN One hundred and twenty patients with SUI were randomized to receive three SIMS: Ajust, MiniArc, and TVT Secur System. Surgical data were compared. RESULTS Significantly (P<0.05) lower surgical difficulty and higher patient satisfaction were detected in the MiniArc group when compared to the Ajust and TVT Secur System groups. A significantly (P<0.05) higher feasibility under local anesthesia and in ambulatory setting was also detected for the MiniArc group. The overall complication rate was significantly (P<0.05) lower in the MiniArc group than in the TVT Secur System group. CONCLUSIONS MiniArc is simpler to insert under local anesthesia and in an ambulatory setting. It is safer than the TVT Secur System, and is related to higher patient satisfaction.

Single-incision Mini-slings Versus Retropubic Tension-free Vaginal Tapes: A Multicenter Clinical Trial

STUDY OBJECTIVE To compare single-incision mini-slings (SIMSs) and retropubic tension-free vaginal tape (r-TVT) in terms of the long-term efficacy and safety for the treatment of female stress (SUI) or mixed urinary incontinence (MUI). DESIGN Prospective multicenter cohort trial (registration number NCT00751088) (Canadian Task Force II). SETTINGS Department of Obstetrics and Gynecology, Italy. PATIENTS Two hundred-forty women with SUI/MUI. INTERVENTIONS SIMS or r-TVT. MEASUREMENTS AND MAIN RESULTS The operative time and the use of analgesic tablets were significantly (p < .001) higher and lower, respectively, in the r-TVT group versus the SIMS group. After 24 months of follow-up, no difference between the study arms was observed in terms of the complication rate (30/120 [25%] vs 19/120 [15.8%] for the r-TVT and SIMS arms, respectively; relative risk = 1.58; 95% confidence interval, 0.94-2.65; p = .083), whereas the subjective cure rate was significantly lower in the SIMS arm than in the r-TVT arm (57/103 [55.3%] vs 89/106 [84.0%] for the r-TVT and SIMS arms, respectively; relative risk = 0.66; 95% confidence interval, 0.54-0.80]; p < .001). The proportion of retreated patients for SUI/MUI was significantly higher in the SIMS arm than in the r-TVT arm (37/103 [34.9%] vs 12/106 [11.3%] for SIMS and r-TVT arm, respectively; p < .001). CONCLUSION SIMS has no advantage in terms of safety over r-TVT and was found to be less effective than r-TVT. Thus, its use in the clinical practice should be questioned.

Do HPV vaccine genotypes agree with circulating HPV types

José A Caminero and colleagues recently reviewed drug treatments for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis, and a 2010 WHO report on XDR tuberculosis emphasised the need for laboratory services worldwide to upgrade to rapid molecular methods. However, peculiarities of phenotypic mycobacterial drug-susceptibility testing and the molecular mechanisms of Mycobacterium tuberculosis drug resistance and cross-resistance confuse the defi nition of XDR tuberculosis. Drug resistance is defi ned as resistance usually to drugs at specifi c concentrations (so-called critical concentrations), which are typically close to wild-type minimum inhibitory concentrations and bear little relation to drug concentrations achievable at the site of infection in patients. The extent of resistance and cross-resistance conferred by distinct mutations diff ers substantially, particularly for those that pertain to isoniazid, the rifamycins, aminoglycosides, and fl uoroquinolones, which are key drugs in the defi nitions of MDR and XDR tuberculosis. Molecular methods proposed to off er quick MDR and XDR tuberculosis diagnoses, such as the GeneXpert, MTBDRplus, and MTBDRsl assays, have an inherent disadvantage: identifi ed mutations are usually interpreted in terms of resistance to entire classes of compounds if not supported by conventional phenotypic methods. The widely heralded GeneXpert identifi es rifampicin resistance only; whether this is suffi cient to infer MDR tuberculosis or to guide therapy is unknown. Similarly, identifi cation of XDR tuberculosis by the MTBDRplus and MTBDRsl assays does not preclude the possibility that treatment with rifabutin, moxifl oxacin, amikacin, and even high-dose isoniazid might be benefi cial. The present XDR tuberculosis defi nition is a useful marker of the quality of regional control programmes and a compelling instrument for advocacy. However, it does not adequately lead to best management for patients. Molecular and phenotypic testing can identify distinct subclasses of XDR tuberculosis that could enable clinical trials of diff erent treatment regimens to be done. This approach would better defi ne the true extent of extensive drug resistance. Although necessary for treatment guidance, such complex diagnoses can only be made in a few qualitycontrolled tuberculosis reference laboratories, generally in developed countries where the burden of the disease is lowest. However, eff orts to improve drug-susceptibility testing should be intensifi ed particularly in areas that have a high prevalence of MDR and XDR tuberculosis. Secondline drug-susceptibility testing with culture-based methods to back up the rapid molecular assays demands sophisticated equipment and might best be done by centralised laboratories. Improved defi nitions of XDR tuberculosis through understanding of the molecular basis of resistance and accurate drugsusceptibility testing will help us to see the true scale of the worldwide tuberculosis resistance issue.

Effectiveness of the Association N-Palmitoylethanolamine and Transpolydatin in the Treatment of Primary Dysmenorrhea

STUDY OBJECTIVE To evaluate the effectiveness and safety of the combination of N-palmitoylethanolamine (PEA) and transpolydatin vs placebo in the treatment of primary dysmenorrhea in adolescents and young women. DESIGN, SETTING, AND PARTICIPANTS Randomized treatment and follow-up of 220 cases of primary dysmenorrhea in the Department of Medicine and Health Sciences, Institute of Gynecology and Obstetrics, University of Molise, Italy. METHODS Between February 2013 and February 2014, we treated 220 young women aged 16 to 24 years who had primary dysmenorrhea: 110 patients were treated with the oral combination of PEA-transpolydatin: 400 mg + 40 mg (1 tablet a day for 10 days from the 24th day of cycle) and 110 patients with placebo (1 tablet a day for 10 days from the 24th day of cycle). A follow-up was performed after treatment, and all girls were seen at this time. A 10-point visual analog scale was used to measure the improvement of pelvic pain. For categorical variables, the χ(2) test and analysis of variance were performed to value the significance of differences between groups. A value of P < .05 was considered statistically significant. RESULTS An improvement of pelvic pain was seen in 98.18% (95% confidence interval 97.64% to 98.60%) of cases in group 1 vs 56.36% (95% confidence interval 48.62% to 63.81%) in group 2 (P < .001). The combination of PEA and transpolydatin was more effective than placebo (P < .001). CONCLUSION The combination of PEA and transpolydatin shows promise as a valid adjuvant therapy in the medical treatment of primary dysmenorrhea in adolescents and young women.

Comment on: Chakera et al. Antenatal Diagnosis of Fetal Genotype Determines if Maternal Hyperglycemia due to a Glucokinase Mutation Requires Treatment. Diabetes Care 2012;35:1832–1834

We have read with great interest the article by Chakera et al. (1) describing two cases of gestational diabetes mellitus due to a mutation in the glucokinase ( GCK ) gene. As a result of antenatal genetic testing, the fetuses had inherited the GCK mutation. Neither fetuses nor mothers received insulin treatment for established maternal hyperglycemia in the third trimester, and the children had a normal birth weight and no metabolic complications. The data of Chakera et al. seemed to confirm our published theory; therefore, a nonmutated GCK child from a maturity-onset diabetes of the young type 2 (MODY2+) mother may have the same complications as a diabetic mothers son and, in this …

Trisomy 1q42-qter associated with monosomy 6q27-qter: A case report

Purpose Partial trisomy 1q42-qter is a rare chromosomal aberration. Most cases arise from de novo unbalanced translocations or from unbalanced inheritance of parental balanced rearrangements. Methods Descriptive case report. Results A 4-year-old boy had shown an increased neck translucency at the fetal ultrasound examination performed at the 11th week of gestation. Amniocentesis, performed at the 18th week of gestation, did not demonstrate any genetic abnormality. A second fetal ultrasound examination, carried out at the 35th week of gestation, showed congenital clubfeet and hydrocephalus. At birth, clinical examination revealed congenital bilateral ventriculomegaly bilateral congenital equinovarus clubfeet, low-set ears, plagiocephaly micrognathia, hypertelorism, prominent forehead, broad nasal bridge, hypertonic syndrome, and inguinal hernia. Ophthalmologic consultation showed the presence of optic pit in his left eye. Genetic counseling was performed. Chromosome analysis demonstrated a partial trisomy 1 q42.2-qter associated with a partial monosomy 6q27-qter. Moreover, deletions of the distal region on the long arm of chromosome 6 are frequently associated with both ocular abnormalities and several solid tumor types. Moderate mental and psychomotor retardation has occurred. Conclusions This case emphasizes the importance of scheduling a screening test for eye diseases and tumor in these patients.