Roberto Montera

Tension-free vaginal tape versus transobturator suburethral tape: Five-year follow-up results of a prospective, randomised trial

BACKGROUND Many studies have assessed the equivalent effectiveness of tension-free vaginal tape (TVT) and transobturator suburethral tape (TVT-O) at short- to medium-term follow-up, but no long-term randomised trials appear in the literature. OBJECTIVE We compared the use of TVT to TVT-O, providing a longer follow-up than currently appears in the literature. DESIGN, SETTING, AND PARTICIPANTS Seventy-two consecutive patients affected by stress urinary incontinence (SUI) were included in this randomised, controlled trial. Patients were randomly allocated to the TVT or TVT-O procedure using a predetermined, computer-generated randomisation code. INTERVENTION After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure. MEASUREMENTS This 5-yr study represents the extension of our original randomised trial, which was designed to assess the incidence of long-term complications (primary end point) and successes (secondary end point) for both techniques. RESULTS AND LIMITATIONS At 60-mo follow-up, 52 patients (72%) were objectively cured of SUI (72.9% after TVT-O and 71.4% after TVT), but only 44 patients (61%) were satisfied. The late complication rate was 16.6% (10 women): five women (16.1%) in the TVT-O group and five women (17.2%) in the TVT group (p=1). In this follow-up, 62% of the patients from the TVT-O group and 60% from the TVT group (p=1) expressed that they were satisfied or very satisfied with the results. The mean cause of dissatisfaction was the development of sexual dysfunction resulting from dyspareunia or incontinence during intercourse, which was found in 6 of 16 dissatisfied patients (37.5%). The limitations of our study included the adequate but small sample size and the lack of questionnaires. CONCLUSIONS Both surgical techniques are safe, with similar results (72.9% and 71% of patients objectively cured after TVT-O and TVT, respectively) and low complication rates (16.6%: 16.1% and 17.2%, respectively, for TVT-0 and TVT), even after 5-yr follow-up.

A new type of absorbable barbed suture for use in laparoscopic myomectomy.

To compare effectiveness, feasibility, and suturing time required between an absorbable barbed wire (V‐Loc) uterine suture and a classic continuous suture with intracorporeal knots among women undergoing laparoscopic myomectomy.

Neoadjuvant chemotherapy plus radical surgery followed by chemotherapy in locally advanced cervical cancer

OBJECTIVES To evaluate the efficacy, in terms of safety, overall survival and progression free survival of neoadjuvant chemotherapy followed by radical surgery plus adjuvant chemotherapy in patients affected by locally advanced cervical cancer (stage IB2-IIB) with or without node metastases. METHODS Between June 2000 and February 2007, all patients with diagnosis of locally advanced cervical cancer referred to the Division of Gynecologic Oncology of the University Campus Bio-Medico of Rome were eligible for this protocol. All enrolled patients received 3 cycles of platinum-based chemotherapy every 3 weeks according to the scheme Cisplatin 100mg/mq and Paclitaxel 175 mg/mq. After neoadjuvant chemotherapy all patients with stable or progressive disease were excluded from the protocol, the others were submitted to classical radical hysterectomy, bilateral salpingo-oophorectomy and bilateral systematic pelvic lymphadenectomy and 4 cycles of adjuvant treatment with platinum based chemotherapy were executed. RESULTS Concerning intention to treat basis analysis, 5 year overall survival (OS) and disease-free survival (DFS) are 77% and 61%, respectively. The 5-year OS of patients with positive pelvic nodes and those with negative nodes metastases was respectively 60% and 87%. Concerning the according to protocol analysis, the 5-year OS and DFS are 81% and 70% respectively. The 5-year OS in patient with positive and negative lymph nodes is 75% and 88% respectively. CONCLUSIONS The adjuvant chemotherapy regimen after neoadjuvant chemotherapy and radical surgery represents a valid treatment for patients with locally advanced cervical cancer.

Feasibility of the Use of Novel Matrix Hemostatic Sealant (FloSeal) to Achieve Hemostasis during Laparoscopic Excision of Endometrioma

STUDY OBJECTIVE To evaluate the use of FloSeal, a 2-component (collagen granules and thrombin) topical hemostatic agent for the control of minor bleeding of the ovarian wall at the end of the laparoscopic stripping procedure for endometriomas. DESIGN Pilot study. SETTING Tertiary care university hospital. PATIENTS Twenty consecutive patients who underwent laparoscopic excision of endometriomas were included in the study. INTERVENTIONS Eight patients was allocated to FloSeal group, whereas the remaining 12 patients were allocated to the control group. MEASUREMENTS AND MAIN RESULTS At the end of the laparoscopic stripping procedure for ovarian cyst (diameter between 3 and 6 cm), the ovarian cortex was carefully everted and thoroughly rinsed to identify the precise localization of bleeding spots. In the FloSeal group the sites of bleeding were covered with FloSeal under direct vision with a laparoscopic applicator. Gentle pressure on the ovary was applied for 5 minutes and subsequently bleeding sites were reexamined. In the control group hemostasis was obtained with conventional methods. Hemostasis was obtained in all cases by 3 minutes from FloSeal application in both study arms. The time of hemostasis was similar in control and FloSeal groups with a median time of 172 and 182 seconds, respectively. CONCLUSION This preliminary series suggests that FloSeal may be used instead of bipolar electric coagulation after excision of ovarian endometriomas. Because the latter was identified by some authors as a possible cause of follicular damage, the use of FloSeal for bleeding control should be investigated in patients undergoing laparoscopic stripping of endometriomas.

Can the preoperative HE4 level predict optimal cytoreduction in patients with advanced ovarian carcinoma

OBJECTIVE Optimal surgical outcome has been proved to be one of the most powerful survival determinants in the management of ovarian cancer patients. Actually, for ovarian cancer patients there is no general consensus on the preoperatively establishment of cytoreducibility. METHODS Between January 2011 and June 2012 patients affected by suspicious advanced ovarian cancer, referred to the Department of Gynecology of Campus Biomedico of Rome were enrolled in the study. All patients had serum CA125 and HE4 measured preoperatively. After a complete laparoscopy to assess the possibility of optimal debulking surgery defined as no visible residual tumor after cytoreduction (RT=0), patients were submitted to primary cytoreductive surgery (Group A) or addressed to neoadjuvant chemotherapy (Group B). RESULTS After diagnostic open laparoscopy, 36 patients underwent optimal primary cytoreductive surgery (Group A) and 21 patients were addressed to neoadjuvant chemotherapy (Group B). In our population, based on ROC curve, the HE4 value of 262pmol/L is the best cut-off to identify patients candidates to optimal cytoreduction with a sensitivity of 86.1% and a specificity of 89.5% (PPV=93.9% and NPV=77%). In addition, CA125 has a sensitivity of 58.3% and a specificity of 84% at cut-off of 414 UI/mL (AUC is 0.68, 95% C.I.=0.620 to 0.861). CONCLUSION Our data indicate that preoperative HE4 is a better predictor for optimal cytoreduction compared to CA125. The best combination in predicting cytoreduction is HE4≤262 pmol/L and ascites <500mL with a sensitivity of 100% and a specificity of 89.5% (PPV=94% and NPV=100%).

Update on urodynamic bladder dysfunctions after radical hysterectomy for cervical cancer

INTRODUCTION Bladder dysfunctions are a common sequela after radical hysterectomy (RH, former type III sec Piver) ranging from 8 to 80%. This discrepancy, probably, reflects the different bladder function evaluation methods utilized in literature. MATERIAL AND METHODS We searched English-language medical reports published from 1952 to 2010, on MEDLINE. Inclusion criteria were: (1) studies of urological dysfunctions in patients with cervical cancer, treated with type III sec Piver (C2 sec Querleu) radical hysterectomy; (2) use of urodynamic measurement. RESULTS The overall incidence of urodynamic bladder dysfunctions is 72%. Follow-up >12 months studies report a high incidence of overactive detrusor low compliance (34%). Eight out of 19 studies show a decrease of the maximal urethral closure pressure (MUCP). DISCUSSION AND CONCLUSIONS Follow-up timing seems to be the major factor influencing the wide range of incidence of bladder dysfunction. Urodynamic data could help physicians to formulate appropriate evaluation and treatment for patients having urge incontinence (UI) after RH.

Update on lymphadenectomy in early and advanced ovarian cancer

Purpose of review Pelvic and para-aortic lymphnode sampling is an integral part of the staging system of ovarian cancer. The issue concerning lymphadenectomy in the management of the disease is still debated, however. The purpose of this paper is to review the role of systematic lymphadenectomy in patients affected by early and advanced-stage ovarian cancer. Recent findings Some retrospective studies have revealed an increased survival rate in early-stage ovarian cancer patients after lymphadenectomy. Recently, the first randomized prospective trial, on lymphadenectomy in advanced-stage disease, was published. It evidenced an improvement in progression-free survival in patients who had undergone lymphadenectomy. Summary Systematic lymphadenectomy has a diagnostic value in early-stage ovarian cancer, thanks to the possibility of accurate clinical staging. As up to 22% of women, who were presumed to have early-stage ovarian cancers, are upstaged during the lymphadenectomy procedure, accurate staging can help to avoid unnecessary postoperative chemotherapy. In patients affected by advanced ovarian cancer, systematic lymphadenectomy statistically significantly improves progression-free survival and reduces recurrence rates despite a higher incidence of postoperative complications. As improvement of overall survival is not statistically significant, further studies are needed to balance risks and benefits of systematic lymphadenectomy in advanced-stage disease.

Ten years of HPV vaccines: State of art and controversies

The human papillomavirus (HPV) represents one of the most common sexually transmitted infections and it has been related to cervical cancer. The HPV vaccines prevent infection with certain species of HPV associated with the development of cervical cancer or genital warts. We carried out a PubMed search up to 2015 evaluating all randomized studies published in literature. This review discusses the current status of HPVs vaccines on the global market, efficacy, safety profiles, controversies and future vaccine developments. Three HPVs vaccines are currently on the global market: bivalent, quadrivalent and ninevalent. Bivalent and quadrivalent vaccines can protect against almost 70% of cervical HPV-related cancerous and precancerous conditions and the ninevalent vaccine, instead, provides a protection against almost 90%. The use of vaccinations raised several controversies in the last years and, currently, is not possible to establish which type of vaccine is most effective, however all of them are safe.

REM (RISK OF ENDOMETRIAL MALIGNANCY): A PROPOSAL FOR A NEW SCORING SYSTEM TO EVALUATE RISK OF ENDOMETRIAL MALIGNANCY .

Purpose: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help the physician are needed to triage patients into high and low risk of endometrial cancer. The purpose of this study was to obtain a predictive model to assess the risk of endometrial malignancy (REM) in women with ultrasound endometrial abnormalities. Experimental Design: Women, between ages 45 to 80 years, diagnosed through ultrasound with endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at the Department of Gynaecologic Oncology of Campus Bio-Medico, University of Rome. Preoperative clinical, ultrasound and laboratory characteristics were taken into account. Logistic regression algorithm was used to categorize patients into low- and high-risk groups for endometrial cancer. Results: A total of 675 patients were considered for the analysis: 88 with endometrial cancer and 587 with benign endometrial disease. We divided the patients into two groups: training set (TS) and verification set (VS). Preoperative age, symptom, HE4 levels, and ultrasound endometrial thickness were found statistically significant, and were included into a multivariate logistic regression model to determine the probability to have endometrial cancer. In the TS, REM reported 93.3% sensitivity and 97.1% specificity [positive predictive value (PPV), 0.83; negative predictive value (NPV), 0.98; AUC, 0.957; 95% confidence interval (CI), 0.908–0.984]. In the VS, REM reported 89.3% sensitivity and 95.4% specificity (PPV, 0.73; NPV, 0.98; AUC, 0.919; 95% CI, 0.829–0.970). Conclusions: Our data support the use of REM to triage patients into low- and high-risk groups for endometrial cancer, even if an external validation of the model is needed. Clin Cancer Res; 19(20); 5733–9. ©2013 AACR.

The effects of giving patients verbal or written pre-operative information in gynecologic oncology surgery: a randomized study and the medical-legal point of view

OBJECTIVES To evaluate the verbal and written preoperative information in patients undergoing surgery for malignant gynaecologic disease, in terms of satisfaction about preoperative received informations, hospitalization days, postoperative pain experienced using visual analogue scale (VAS) and number of pain drugs used daily. STUDY DESIGN From January 2008 to December 2012, consecutive patients with diagnosis of endometrial cancer, referred to the Division of Gynecology of University Campus Bio-Medico of Rome, were enrolled. Eligible subjects were randomized into two groups: Group V (Verbal information ward) consisted of patients who had verbal preoperative information about surgical procedure and postoperative management and Group W (Written Information ward) consisted of patients who had written preoperative information. All preoperative and postoperative data were recorded. Concerning satisfaction about preoperative received informations, patients were asked to complete the QLQ-C30 and the EORTC INFO25. RESULTS 190 patients were considered in this study. Group W (n=92) has a better info satisfaction (p=0.0008, statistically significant), a mean VAS value lower (p=0.02, statistically significant) and also a lower number of hospitalization days (p=0.0265, statistically significant) and pain medications used daily, (p=0.0120, statistically significant), comparing with group V (n=98). CONCLUSIONS We support the use of preoperative information leaflet to better prepare patients for a surgical procedure, showing a faster recovery, low medications use and a better quality of life outcome.