Stefano Restaino

Effects of hormonal contraception on vaginal flora

BACKGROUND The sector of the market that deals with contraception offers a long list of different contraceptive methods. Within the estroprogestinic choice, the routes of administration are oral, transdermic and vaginal one. Even though efficacy is comparable with these methods, secondary and adverse effects are directly involved in the acceptability of the method. STUDY DESIGN This was a prospective comparative study. During 1 year, we enrolled 60 asymptomatic women who voluntarily requested combined oral contraception (COC) or combined contraceptive vaginal ring (CCVR group). After a baseline study of vaginal milieu prior to starting hormonal contraception, we performed a follow-up. For each woman, we examined vaginal pH; quantification of leukocytes, lactobacilli, Candida and cocci on saline microscopy fluid; Gram stain with Nugent score and the presence of vaginal infection [culture for Trichomonas vaginalis, albicans and nonalbicans Candida, Group B Streptococcus (GBS)]. RESULTS At the end of follow-up, there was a little change of vaginal milieu in both groups. We noted an increase of lactobacilli in the CCVR users and an increase of GBS in COC users. CONCLUSION CCVR compared to COC users showed an increase of the number of lactobacilli in vaginal flora. It means that an increase of leukorrhea in that group could be protective in terms of prevention of vaginal imbalance/infection.

Telelap ALF-X vs Standard Laparoscopy for the Treatment of Early-Stage Endometrial Cancer: A Single-Institution Retrospective Cohort Study

STUDY OBJECTIVE To compare the surgical and clinical outcomes of patients affected by early-stage endometrial cancer treated using the Telelap ALF-X platform versus conventional laparoscopic surgery. DESIGN Single institution retrospective cohort study (Canadian Task Force classification II-2). SETTING Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy. PATIENTS The study involved 89 patients affected by early-stage endometrial cancer who underwent elective surgical staging between October 2013 and September 2014. Among them, 43 (48.3%) underwent Telelap ALF-X staging (ALF-X group), and 46 (51.7%) underwent conventional laparoscopic staging (laparoscopic group). INTERVENTIONS All selected patients underwent laparoscopic staging with radical hysterectomy (class A sec Querleu-Morrow), bilateral salpingo-oophorectomy, and pelvic lymphadenectomy if required. The 2 surgical groups were further divided into patients who did not require pelvic lymphadenectomy (subgroup 1) and those who underwent pelvic lymphadenectomy (subgroup 2). MEASUREMENTS AND MAIN RESULTS In the ALF-X group, the median operative time was 128 minutes (range, 69-260 minutes) for subgroup 1 and 193 minutes (range, 129-290 minutes) for subgroup 2. In the laparoscopic group, the median operative time was 82 minutes (range, 25-180 minutes) in subgroup 1 and 104 minutes (range, 36-160 minutes) in subgroup 2. The difference in operative time between subgroups was statistically significant in both the ALF-X and laparoscopic groups (p = .000). In subgroup 1 of the ALF-X group, there was 1 conversion to standard laparoscopy (2.3%) and 2 conversions to laparotomy (4.7%) (p = .234). No conversions to laparotomy occurred in the laparoscopic group. Postoperative complications included 1 case of pelvic hematoma (2.3%) in subgroup 1 of the ALF-X group and 1 case of subocclusion and 1 case of pulmonary edema (4.3%) in subgroup 1 of the laparoscopic group. CONCLUSION Based on operative outcomes and complication rates, our results suggest that the Telelap ALF-X approach is feasible and safe for endometrial cancer staging; however, further studies are needed to definitively assess the role of Telelap ALF-X early-stage endometrial cancer staging.

Diabetes in Pregnancy: Timing and Mode of Delivery

Diabetes in pregnancy represents a risk condition for adverse maternal and feto-neonatal outcomes and many of these complications might occur during labor and delivery. In this context, the obstetrician managing women with pre-existing and gestational diabetes should consider (1) how these conditions might affect labor and delivery outcomes; (2) what are the current recommendations on management; and (3) which other factors should be considered to decide about the timing and mode of delivery. The analysis of the studies considered in this review leads to the conclusion that the decision to deliver should be primarily intended to reduce the risk of stillbirth, macrosomia, and shoulder dystocia. In this context, this review provides useful information for managing specific subgroups of diabetic women that may present overlapping risk factors, such as women with insulin-requiring diabetes and/or obesity and/or prenatal suspicion of macrosomic fetus. To date, the lack of definitive evidences and the complexity of the problem suggest that the “appropriate” clinical management should be customized according with the clinical condition, the type and mode of intervention, its consequences on outcomes, and considering the woman’s consent and informed decisions.

Risk of essure microinsert abdominal migration: Case report and review of literature

Purpose To report a case of Essure microinsert abdominal migration and literature review. Methods A 41-year-old woman was counseled to undergo Essure sterilization. The procedure was hampered by the presence of endometrial cavity adhesions, obscuring left tubal ostium. By using microscissors the adhesions were progressively lysed. Since the procedure had become very painful, the patient required general anesthesia. Once adhesion lysis was completed, the tubal ostium was well visible. Both devices were then easily introduced into the fallopian tubes. At the end of the procedure, five coils were visible on the right side and five coils on the left side, as recommended. Results The 3-month hysterosalpingogram follow-up suspected abdominal migration of the left device. Laparoscopy confirmed the device displacement in the left lower abdominal quadrant. Both fallopian tubes and the uterus appeared normal. No signs of perforation were detected. The device was embedded into the omentum, but it was easily removed. Bilateral tubal sterilization was performed by bipolar coagulation. Conclusion There are only 13 cases, including the present, of Essure abdominal migration in the literature. In most cases, abdominal displacement of the microinsert is asymptomatic and does not induce tissue damage. However, in some cases, it may cause a severe adverse event, requiring major surgery. Therefore, removal of the migrated device should be performed as soon as possible. Moreover, during presterilization counseling, the patient should also be correctly informed about the risk of this rare but relevant complication, as well as about the surgical interventions that could be required to solve it.

The impact on survival of two different staging strategies in apparent early stage endometrial cancer comparing sentinel lymph nodes mapping algorithm and selective lymphadenectomy: An Italian retrospective analysis of two reference centers

OBJECTIVE The role of lymphadenectomy in endometrial cancer is still uncertain. We aimed to evaluate the survival outcomes of two different strategies in apparent uterine confined disease by comparing sentinel lymph node (SLN) mapping and selective lymphadenectomy (LD). METHODS We retrospectively reviewed women with preoperative stage I endometrial cancer underwent surgical staging with either SLN mapping, or LD in two Italian centers. RESULTS Eight hundred and two women underwent surgical staging for preoperative stage I endometrial cancer were revised (145 Monza; 657 Rome). All patients underwent peritoneal washing, simple hysterectomy with bilateral salpingo-oophorectomy and nodal staging including SLN mapping, or LD. Overall 8229 lymph nodes were removed (1595 in Monza, 6634 in Rome). Pelvic lymphadenectomy was performed in 33.1% and 52.4% in Monza and Rome, respectively (p<0.001). Patients with positive pelvic LN were 16.7% and 7.3%, in SLN and LD groups, respectively (p=0.002). Disease-free survival (DFS) curves did not showed a statistically significant difference between centers and strategies adopted (SLN mapping, LD, SLN+LD) with a HR of 0.87 (95% CI 0.63-2.16; p=0.475). CONCLUSIONS Survival outcomes were similar for both strategies. The SLN strategy allowed to identify a higher rate of stage IIIC1 disease even with a lower median number of lymph node removed in SLN group. Applying a SLN algorithm does not impair the prognosis of endometrial cancer patients. The clinical impact and management of low volume metastasis in high-risk patients should be further clarify.

Effects of estroprogestins containing natural estrogen on vaginal flora.

Abstract Estroprogestins with “natural oestrogen” has represented a new option in terms of combined hormonal contraception. So, the aim of this study is to investigate how estroprogestins with natural estrogen may modify the vaginal niche. In literature, very few studies focused on the interaction between hormonal contraception and vaginal milieu. This is a prospective comparative study. We enrolled 60 women from January 2013 to September 2013, 30 of them were administered estradiol valerate dienogest (E2V+DNG – Klaira®) in a quadriphasic regimen, while the other 30 women were administered 17-β estradiol with nomestrol acetate (EV+NOMAC – Zoely®) in a monophasic regimen. After a baseline study of vaginal milieu at recruitment of patients (Gram stain with Nugent score, vaginal pH, vaginal wet mount for the quantification of leukocytes, Lactobacilli and/or presence of Candida), we performed the same follow-up after six months of estroprogestin therapy. Our results showed that the women treated with E2V+DNG had a trend of an improvement of vaginal health in terms of increase of lactobacillar flora and reduction of vaginal pH in place of women treated with EV+NOMAC that showed a reduction of cervical mucus. Finally, our data about the effects on vaginal flora exerted by two estroprogestin pills (EPs) containing a natural estrogen suggest slight, but interesting differences in terms of vaginal ecology. These differences could be related to the type of estrogen, type of progestin, regimen of administration and, after all, to the net balance between estrogenic and progestin component of the EPs. Chinese abstract 含有天然雌激素的避孕药是复合激素避孕药的一种新选择。本研究的目的在于了解含有天然雌激素的避孕药可能对阴道微环境改变的程度。现有的文献很少研究激素避孕药和阴道环境的相互作用。这是一项前瞻性的对照研究。2013年1月至2013年9月我们募集了60名女性，其中30名女性口服四相的戊酸雌二醇地诺孕素复合制剂（E2V+DNG-Klaira），另外30名女性口服单相的17-β雌二醇和醋酸诺美孕酮复合制剂（EV+NOMAC –Zoely）。对研究对象的阴道环境（革兰染色Nugent评分，阴道PH值，阴道湿涂片行白细胞及乳酸杆菌计数，是否合并念珠菌）做基线研究，口服避孕药6个月后对上述指标再次进行测量。我们的结果显示：口服E2V+DNG的女性通过增加乳酸杆菌、降低阴道PH值有改善阴道健康的趋势，而口服EV+NOMAC的女性宫颈粘液减少。最终，我们的资料显示：两种含有天然雌激素的避孕药对阴道菌群的影响在阴道生态方面有细小的、有趣的差别。这些差别可能与雌、孕激素的种类、时相相关，归根到底和避孕药中雌孕激素的组分有关。

Bilateral Ureteral Stent Removal after 15 Years: A Case Report

We present the first reported case of a patient with a forgotten ureteral stent. A 68-year-old woman had undergone radical hysterectomy for cervical cancer in 1997, at which time bilateral ureteral stents were placed. She was admitted to our hospital with stranguria, dysuria, and lower back pain of 10 days duration. Preoperative radiologic evaluation revealed the presence of ureteral stents, which had been in place since 1997. With the patient under general anesthesia, the bilateral stents were removed by urethral cystoscopy. No stone formation was noted. The procedure was easy and fast, and no intraoperative complications occurred.

Preoperative serum human epididymis protein 4 levels in early stage endometrial cancer: A prospective study

Objective The aim of the study was to evaluate the prognostic value of human epididymis protein 4 (HE4) and cancer antigen 125 markers with pathological prognostic factor to complete the preoperative clinical panel and help the treatment planning. Methods This prospective multicenter study was conducted in 2 gynecologic oncology centers between 2012 and 2014 (Institute for Maternal and Child Health IRCCS Burlo Garofolo in Trieste and Catholic University of the Sacred Heart in Rome, Italy). We enrolled 153 patients diagnosed with clinical early (International Federation of Gynecology and Obstetrics stages I–II) type I endometrial cancer. Results Human epididymis protein 4 levels seemed to be strictly related to age (P < 0.001) and menopausal status (P < 0.002). Compared with myometrial invasion (MI), the HE4 values were significantly higher in case of invasion of greater than 50% of the thickness: MI of greater than 50%, median of 94.85 pmol/L (38.3–820.8 pmol/L), versus MI of less than 50%, median of 65.65 pmol/L (25.1–360.2 pmol/L), (P < 0.001). The HE4 levels increase significantly with increasing tumor size: diameter of larger than 2 cm, median of 86.9 pmol/L (35.8–820.8 pmol/L), versus diameter of smaller than 2 cm, median of 52.2 pmol/L (33.3–146.8 pmol/L), (P < 0.001). In our population, HE4 did not correlate with the histological grade, endometrial cancer type I versus type II (P = 0.86), the lymphovascular infiltration (P = 0.12), and the cervical invasion (P = 0.6). We established a new variable, considering 3 high-risk tumor features: MI of greater than 50% and/or histological G3 and/or type II. Human epididymis protein 4 levels significantly increase in high-risk tumors (high risk HE4, 93.6 pmol/L vs low-medium risk, 65.5 pmol/L; P < 0.001). Conclusions A preoperative HE4 evaluation could help stratify patients with deep invasion and/or metastatic disease and is correlated with other relevant prognostic factors to be considered to tailor an adequate surgical strategy.