A randomized controlled trial on the oncologic outcomes of use of the intrauterine manipulator in the treatment of apparent uterine-confined endometrial carcinoma: the MANEC Trial.

BACKGROUND: The intrauterine manipulator used during a hysterectomy for endometrial cancer has been suggested as a reason for worsening oncologic outcomes. However, only a few non-randomized retrospective studies have investigated this association. PRIMARY OBJECTIVES: To compare 4-year recurrence-free survival in the group of patients who undergo hysterectomy using an intrauterine manipulator with that of those who undergo hysterectomy without it. STUDY HYPOTHESIS: Patients with endometrial cancer who undergo laparoscopic hysterectomy performed with an intrauterine manipulator would have a lower recurrence-free survival than patients who undergo laparoscopic hysterectomy without a manipulator. TRIAL DESIGN: Multicenter, parallel arm, open-label, randomized controlled trial. MAJOR INCLUSION/EXCLUSION CRITERIA: Adult women diagnosed with apparently uterine-confined endometrial cancer of any histology are eligible. We exclude women who had synchronous or previous (<5 years) invasive cancer, had a WHO performance score >2, and had inadequate baseline organ function. PRIMARY ENDPOINTS: 4-Year recurrence-free survival defined as any relapse or death related to endometrial cancer or treatment calculated from randomization to the date of the first recurrence-free survival event. SAMPLE SIZE: With an accrual time of 4 years, a minimum follow-up length of 4 years, and a two-sided type I error of 0.05, we need to enroll 515 women per arm to have a statistical power of 80% to reject the null hypothesis (HR for recurrence=1), assuming that patients who undergo hysterectomy with the use of the intrauterine manipulator have a 3-year recurrence rate of 12.5% and without the use of the intrauterine manipulator of 8.5% (HR for recurrence=1.50), and that 5% of patients are lost at follow-up in each arm, with a median time of 24 months. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual completion is expected in 2028, and result presentation in 2032. TRIAL REGISTRATION: ClinicalTrial.gov ID NCT05687084.

SARS-CoV-2 infection testing at delivery: a clinical and epidemiological priority.

BACKGROUND: Universal testing has been suggested as a useful strategy for a safe exit from the total lockdown, without recurrence of COVID-19 epidemic, delivering women being considered a sentinel population. Further universal testing for pregnant women may be useful in order to define appropriate access to COVID19 areas, dedicated neonatal care, and personal protective equipment. METHODS: During the period 10-26 April, all consecutive women admitted for delivery at the Maternity Hospitals of the city of Milan and in six provinces of Lombardy: Brescia, Como, Lecco Monza, Pavia, and Sondrio. areas were tested with nasopharyngeal swabs.Results and conclusion: Out of 1566 women, 49 were tested positive for SARS-Cov-2 (3.1%, 95% Confidence Interval (CI) 2.3-4.0). This value is largely higher than Heath Authorities estimate. Of tested positive women, 22 (44.9%) had symptoms or reported close contacts with positive patients, that is were found at risk by the itemized questionnaire. In conclusion, routine estimate of frequency of positivity among delivering women can be consider a useful methods to monitor positivity at least in females in their fertile ages.

Prospective evaluation of ERCP performance in an Italian regional database study.

BACKGROUND: Prospective studies about endoscopic retrograde cholangio-pancreatography (ERCP) in a community setting are rare. AIM: To assess success and complication rates of routinely-performed ERCP in a regional setting, and the priority quality indicators for ERCP practice. METHODS: Prospective region wide observational study on consecutive patients undergoing ERCP during a 6-month period. A centralized online ERCP questionnaire was built and used for data storage. Primary quality indicators provided by the American Society of Gastrointestinal Endoscopy (ASGE) were considered. RESULTS: 38 endoscopists from 18 centers performed a total of 2388 ERCP. The most common indication for ERCP was choledocholitiasis (54.8%) followed by malignant jaundice (22.6%). Cannulation of the desired duct was obtained in 2293 cases (96%) and ERCP was successful in 2176 cases (91.1%). Success and ERCP difficulty were significantly related to the experience of the operator (p = 0.001 and p < 0.001, respectively). ERCP difficulty was also significantly related to volume centers (p < 0.01). The overall complication rate was 8.4%: post-ERCP pancreatitis (PEP) occurred in 4.1% of procedures, bleeding in 2.9%, infection in 0.8%, perforation in 0.4%. Mortality rate was 0.4%. All the ASGE priority quality indicators for ERCP were confirmed. CONCLUSIONS: The procedural questionnaire proved to be an important tool to assess and verify the quality of routinely-performed ERCP performance in a community setting.

Complications and early mortality in percutaneous endoscopic gastrostomy placement in lombardy: A multicenter prospective cohort study.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) is the most common endoscopic procedure used to provide nutritional support. AIM: To prospectively evaluate the mortality and complication incidences after PEG insertion or replacement. METHODS: All patients who underwent PEG insertion or replacement were included. Details on patient characteristics, ongoing therapies, comorbidities, and indication for PEG placement/replacement were collected, along with informed consent form signatures. Early and late (30-day) complications and mortality were assessed. RESULTS: 950 patients (47.1% male) were enrolled in 25 centers in Lombardy, a region of Northern Italy. Patient mean age was 73 years. 69.5% of patients had ASA status 3 or 4. First PEG placement was performed in 594 patients. Complication and mortality incidences were 4.8% and 5.2%, respectively. The most frequent complication was infection (50%), followed by bleeding (32.1%), tube dislodgment (14.3%), and buried bumper syndrome (3.6%). At multivariable analysis, age (OR 1.08 per 1-year increase, 95% CI, 1.0-1.16, p = 0.010) and BMI (OR 0.86 per 1-point increase, 95% CI, 0.77-0.96, p = 0.014) were factors associated with mortality. PEG replacement was carried out in 356 patients. Thirty-day mortality was 1.8%, while complications occurred in 1.7% of patients. CONCLUSIONS: Our data confirm that PEG placement is a safe procedure. Mortality was not related to the procedure itself, confirming that careful patient selection is warranted.

Natural history of cervical intraepithelial neoplasia during pregnancy.

OBJECTIVE: It is uncertain whether pregnancy influences the natural history of cervical intraepithelial neoplasia (CIN). Our aim was to evaluate the evolution of CIN in pregnant women. DESIGN: Prospective study. SETTING: Department of Obstetrics and Gynaecology, University of Insubria, Italy. POPULATION: Women with histological CIN during pregnancy. METHODS AND MAIN OUTCOME MEASURES: Between 2003 and 2007, women with an abnormal Pap-smear during pregnancy underwent colposcopy. Patients with histological CIN were followed during pregnancy with colposcopy every 8 weeks and post-partum evaluation was scheduled 3-6 months after delivery. Women with post-partum histological diagnosis of CIN 2-3 underwent conization. To understand the impact of pregnancy on the evolution of CIN, women with CIN 1 discovered during pregnancy were compared to a group of non-pregnant fertile patients with first diagnosis of CIN 1. RESULTS: A total of 78 women were included: 36 (46.2%) with CIN 2-3 and 42 (53.8%) with CIN 1. In women with CIN 2-3, no invasion was suspected during pregnancy and at post-partum evaluation, no invasive or microinvasive cancer, and 19 (52.7%) persistent CIN 2-3, and 17 (47.3%) regressions were diagnosed. In the group of CIN 1, we recorded six (14.3%) progressions to CIN 2-3, seven (16.6%) persistent CIN 1 and 29 (69%) regressions. The control group of non-pregnant women had a lower regression rate (37/76: 48.7%) in comparison to pregnant women (p=0.03). CONCLUSIONS: Expectant management for CIN 2-3 diagnosed during gestation is safe. When discovered during pregnancy, CIN 1 has a significantly higher tendency to spontaneous regression in comparison to non-pregnant condition.

Early and delayed complications of polypectomy in a community setting: The SPoC prospective multicentre trial.

BACKGROUND: Colonoscopic polypectomy is effective in reducing the incidence of and mortality from colorectal cancer, but is not complication-free. AIMS: To evaluate the incidence of early and delayed polypectomy complications and factors associated with their occurrence in a community setting. METHODS: Web-database collection of patients' and polyp's features in consecutive colonic polypectomies during a 3-month period in 18 endoscopy centres. RESULTS: Data on 5178 polypectomies in 2692 patients (54.3% males, mean age 59 years) were collected. The majority of the polyps were <10mm (83.5%). Antithrombotic agents were taken by 22.7% of patients, 57.3% of which withheld them before the procedure. Overall, 5 patients experienced perforations (0.2%) and 114 had bleeding (4.2%); the overall complication rate was 4.4%. Early complications were observed in 87 (3.2%); delayed complications (all major bleedings) occurred in 32 (1.2%). At multivariate analysis polyp size (size >10mm: OR 4.35, 95% CI 5.53-7.48) and, inversely, right-sided location (OR 0.58, 95% CI 0.36-0.94) were correlated with bleeding events. The use of antithrombotics was associated with 5-fold increased risk of delayed bleeding. CONCLUSIONS: In the community setting, polypectomy was associated with a 1.4% risk of major complications. Polyp size and, inversely, right-sided location were associated with early bleeding; the use of antithrombotics increased the risk of delayed events.

"Kissing ovaries": a sonographic sign of moderate to severe endometriosis.

OBJECTIVE: To evaluate whether the presence of kissing ovaries at ultrasound is a marker for endometriosis and whether it correlates with the severity of the disease. DESIGN: Prospective observational study. SETTING: Gynecologic departments of two university hospitals. PATIENT(S): A total of 722 consecutive premenopausal women who had laparoscopic surgery for an adnexal mass or suspected pelvic endometriosis. INTERVENTION(S): Preoperative ultrasound evaluation and laparoscopic surgery. MAIN OUTCOME MEASURE(S): Diagnostic and predictive value of ultrasound identification of kissing ovaries in the detection of endometriosis. RESULT(S): Kissing ovaries were diagnosed at ultrasound and confirmed laparoscopically in 32 patients. Of these, 27 had moderate to severe endometriosis and five others had benign adnexal masses. Bowel (18.5% vs. 2.5%) and fallopian tube (92.6% vs. 33%) endometriosis were significantly more frequent in patients with kissing ovaries than in patients without kissing ovaries. In infertile patients (n = 145), kissing ovaries were associated with a higher proportion of women with fallopian tube obstruction (80% vs. 8.6%). Considering patients with moderate to severe endometriosis (n = 189), the median (range) revised American Fertility Society score (74 [32-148] vs. 35 [16-146]) and the operative time (115 minutes [65-245 minutes] vs. 50 [15-180 minutes]) were significantly higher in patients with than in those without kissing ovaries. CONCLUSION(S): The detection of kissing ovaries at ultrasound is strongly associated with the presence of endometriosis and is a marker of the most severe form of this disease.

Determinants of short term recurrence rate of endometriosis.

OBJECTIVE: To analyse the frequency and the determinants of recurrence rate of clinically detectable endometriosis. STUDY DESIGN: Prospective cohort multicenter study. Eligible for the study were all women observed for the first time during the period January-June 1998 at the participating centres with a laparoscopically confirmed first diagnosis of endometriosis. After diagnosis, patients were treated according to standard care of each centre and desire for pregnancy. The protocol required all women to be followed up at the centre each year for 2 years with a clinical examination, an ultrasound pelvic examination and a CA125 assay, unless pregnancy occurred. Second look laparoscopy was performed on a clinical basis. RESULTS: A total of 311 women (median age 36 years) entered the study. The two-year recurrence rate was 5.7% among cases stage I-II and 14.4% among stage III-IV (chi(1)2 adjusted for indication for surgery, p < 0.05). The recurrence rates tended to increase with age, being 4.6% among women aged 20-30 and 13.1% among women aged >30, but this finding was not statistically significant. CONCLUSION: The recurrence rate of clinically detectable endometriosis tends to be higher in older women with advanced stages of the disease and lower in women with infertility.

Opening vesical pressure: a new test to discriminate urethral sphincter deficiency?

Urethral sphincter deficiency (USD) is not standardised. Opening vesical pressure could reflect the pressure exerted to overcome urethral resistance during void; thus, we evaluated if it could discriminate USD. Women with urinary symptoms were prospectively assessed with a questionnaire and urodynamics and divided into three groups: urodynamic stress incontinence with USD (group 1), urodynamic stress incontinence related to urethral hypermobility without USD (group 2) and normal urodynamic (group 3). USD was defined as the concomitant presence of severe urodynamic stress incontinence, VLPP <60 cm H2O, MUCP <20 cm H2O and urethral mobility <30 degrees . A total of 145 women were enrolled: 56 in group 1, 50 in group 2 and 39 in group 3. The three groups did not differ for demographics, obstetric and surgical history. The median values for opening vesical pressures were 17.5 (15.6-22.2 95%CI), 30 (27.0-37.3 95%CI) and 30 (30.6-44.2 95% CI) for the groups 1, 2 and 3, respectively. A p value <0.0001 was found when comparing group 1 either with group 2 or 3. Opening vesical pressure is a promising parameter to detect USD.

Laparoscopic management of endometrial cancer in nonobese and obese women: A consecutive series.

STUDY OBJECTIVE: To assess the technical feasibility and surgical outcome of a 5 mm-ports technique in a consecutive series of women with endometrial cancer laparoscopically managed. DESIGN: Prospective collaborative cohort study (Canadian Task Force classification II-2). SETTING: Two gynecologic oncology units of university hospitals. PATIENTS: A series of consecutive patients undergoing laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the treatment of endometrial cancer. INTERVENTIONS: A 10-mm zero-degree umbilical operative laparoscope and three 5-mm suprapubic trocars were used. The lymph nodes were removed with the use of a specimen bag through the umbilical port. Intraoperative and postoperative details and complications were prospectively collected. MEASUREMENTS AND MAIN RESULTS: A total of 101 patients were enrolled. Twenty-two (21.8%) had a body mass index (BMI) of 30 kg/m2 or higher, and nine (8.9%) were severely obese (BMI > or =35 kg/m2). One hundred procedures (99%) were carried out entirely with only three 5-mm ancillary trocars. In one patient, a 5-mm trocar was replaced with a 10-mm trocar because of a lesion of the external iliac vein requiring the placement of vascular clips. One procedure needed to be converted to laparotomy. Intraoperative complications occurred in three patients (one bladder injury and one iliac vein injury, both managed laparoscopically, and one subcutaneous emphysema). Postoperative complications occurred in 10 (10%) patients. The only complication requiring a subsequent intervention was a symptomatic pelvic lymphocyst. No difference was found in surgical outcomes between obese women and those of ideal BMI. CONCLUSION: The use of only 5-mm ancillary trocars for the laparoscopic treatment of endometrial cancer can further minimize surgical invasiveness without compromising surgical efficacy and safety in patients with high BMI as well as for women with ideal BMI.

Laparoscopic-assisted vaginal hysterectomy versus total laparoscopic hysterectomy for the management of endometrial cancer: a randomized clinical trial.

STUDY OBJECTIVE: To compare laparoscopic-assisted vaginal hysterectomy (LAVH) and total laparoscopic hysterectomy (TLH) for the treatment of endometrial cancer. DESIGN: Randomized, controlled trial. DESIGN CLASSIFICATION: Randomized controlled trial (Canadian Task Force classification I). SETTING: Two gynecologic oncologic units of university hospitals. PATIENTS: Seventy-two women with endometrial cancer randomized to undergo either LAVH or TLH. INTERVENTIONS: Total laparoscopic hysterectomy or laparoscopic-assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washing, and systematic pelvic lymphadenectomy. MEASUREMENTS AND MAIN RESULTS: Parameters of technical feasibility (operating time of hysterectomy phase, estimated blood loss, perioperative complications) were considered as major statistical endpoints. Thirty-seven women were allocated to the LAVH arm, and 35 were allocated to the TLH arm. Mean total operating time was significantly shorter in the TLH than in the LAVH group (184.0 +/- 46.0 vs 213.2 +/- 39.4 minutes, p = .003). The hysterectomy phase was longer in the LAVH than in the TLH group only in overweight (77.9 +/- 9.8 vs 68.1 +/- 9.3 min, p = .005) and obese patients (87.7+/- 13.1 vs. 62.1+/- 9.9 min, p < .0001). The median estimated blood loss during hysterectomy was similar between groups. Intraoperative complications occurred in three (8.1%) patients in the LAVH group and in one patient (2.8%) in the TLH group (p = .61). No difference was found in the postoperative complication rate between women undergoing LAVH and those who had TLH (24.3% vs 17.1%, p = .56). Within a median follow-up period of 10 months (range 3-17 months), 2 patients in the LAVH group developed recurrent disease. No port site metastasis and no vaginal cuff recurrence were detected in either group. CONCLUSION: Both LAVH and TLH can be performed successfully to manage endometrial cancer, with similar surgical outcomes. Obese patients benefit more from TLH than from LAVH in terms of shorter operating time.