Anna Fagotti

Catholic University of the Sacred Heart , Milano, Lombardy, Italy

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Publications (180)572.02 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: To assess the learning curve associated with tele-assisted surgery. We performed a training box-based study, describing speed and accuracy in volunteers performing basic and complex laparoscopic tasks, to assess performance and in the skill acquisition of inexperienced users, using the Telelap Alf X system. Ten surgeons in gynaecology who had never received formal instruction on this new surgical device, completed four modules during a consecutive 3 day training programme. All the participants completed the training programme with a good learning curve. Use of the TELELAP Alf X advanced surgical robotic system is associated with a rapid learning curve among experienced surgeons. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    International Journal of Medical Robotics and Computer Assisted Surgery 06/2015; DOI:10.1002/rcs.1672 · 1.53 Impact Factor
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    ABSTRACT: The aim of this study was to compare the toxicity, perioperative outcomes of interval debulking surgery (IDS), and duration of progression-free survival (PFS) in women with unresectable high-grade serous advanced ovarian cancer (AOC) receiving neoadjuvant chemotherapy (NACT) with or without bevacizumab. Twenty-five patients with high-grade serous AOC treated with bevacizumab-based NACT (cases) were matched according to initial disease extension assessed by laparoscopy, and age, in a 1:2 ratio, with 50 high-grade serous AOC patients treated with standard NACT without bevacizumab (controls). Both groups received a median of four NACT cycles before IDS (p = 0.867), and the median time interval between NACT and IDS was 27 days in both groups (p = 0.547). Twenty-two cases (88.0 %) showed complete/partial radiologic response compared with 36 controls (72.3 %; p = 0.054). A higher percentage of cases showed complete serological response (48 vs. 35.1 %; p = 0.041). At IDS, complete cytoreduction was achieved in 20 cases (80.0 %) and 36 controls (72.3 %) [p = 0.260]. No differences were observed between groups in terms of surgical complexity score, perioperative outcomes, surgical complications, and chemotherapy-related adverse events. One death due to gastrointestinal perforation was observed among cases. Cases showed a longer median PFS compared with controls (18 months vs. 10 months; p = 0.001), and the administration of bevacizumab (hazard ratio 3.786; p = 0.001) retained a prognostic role for longer PFS at multivariate analysis. The incorporation of bevacizumab in NACT prolongs PFS without affecting the safety of IDS. The risk of gastrointestinal perforation should be considered prior to attempting bevacizumab-based NACT in women with diffuse bowel involvement at initial laparoscopic evaluation.
    Annals of Surgical Oncology 06/2015; DOI:10.1245/s10434-015-4651-8 · 3.94 Impact Factor
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    ABSTRACT: This prospective single-institutional clinical trial sought to assess the safety and feasibility of laparoscopic benign ovarian cyst enucleation with a novel robot-assisted laparoscopic system. In this study, we report a series of 10 cases treated using Telelap ALF-X in the first clinical application on patients at the Division of Gynaecologic Oncology, Catholic University of the Sacred Heart of Rome. The primary inclusion criterion was the presence of monolateral ovarian cyst without a preoperative assessment suspicious for malignancy. Intra-operative data such as docking time, operative time, estimated blood loss, intra and peri-operative complications, and conversion to either standard laparoscopy or laparotomy were collected. The cysts were removed using the ovary sparing technique with respect to conservative surgical principles. The median operative time was 46,3 min, and patients without post-operative complications were discharged either 1 or 2 days after the procedure. Telelap Alf-X laparoscopic enucleation of benign ovarian cysts with ovary sparing techniques is feasible, safe and effective. However, more clinical data are needed to assess whether this approach would offer any other benefits compared to other minimally invasive surgical techniques. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.
    Journal of Minimally Invasive Gynecology 05/2015; DOI:10.1016/j.jmig.2015.05.007 · 1.58 Impact Factor
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    ABSTRACT: Phase II study on total TELELAP ALF-X hysterectomy. safety, feasibility and perioperative outcomes analysis. Phase II study. Canadian Task Force II-2. Catholic University of the Sacred Heart, Rome, Italy. From October 2013 to May 2014, 80 women underwent total TELELAP ALF X hysterectomy. The study population was divided in two groups according to surgical procedures: total hysterectomy ± bilateral salpingo-oophorectomy (Group 1), and endometrial cancer patients staged also with pelvic lymphadenectomy (Group 2). Total TELELAP ALF-X hysterectomy ± bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy. Median age was 51 years (range 48-79), and median BMI was 24 kg/m2 (range 17.3 - 34.2). Forty-five patients (56.2%) had previous surgery. Median operative time was 140 minutes (range 58-320) in the Group 1 and 197 minutes (range 129-290) in the Group 2 (p < .001). Median docking time was 8 minutes (range 3-25). During the study period, a significant trend in the operative time reduction was observed. Procedures were successfully performed without conversion in 93.7% of cases. We observed 2 (2.5%) intraoperative complications, 3 (3.7%) conversions to standard laparoscopy and 2 (2.5%) to laparotomy. Median time to discharge was 2 days (range 1-5). One patient (1.2%) was readmitted the early post-operative period. As new technology evolves, critical appraisal of patient-related outcomes, utilization, cost, and access to minimally invasive hysterectomy must remain a priority. Despite the relative small number of our series, we showed the feasibility and safety of total TELELAP ALF-X hysterectomy for benig and malignant disease. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.
    Journal of Minimally Invasive Gynecology 05/2015; DOI:10.1016/j.jmig.2015.05.004 · 1.58 Impact Factor
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    ABSTRACT: Recurrence of disease represents a clinical challenge in cervical cancer patients, especially when all available treatment modalities have been used in the primary setting. The aim of this study was to analyse the patterns of recurrence and their association with clinical outcome in locally advanced cervical cancer (LACC) patients submitted to primary chemoradiation (CTRT) followed by radical surgery (RS). This study was conducted on 364 LACC patients treated with CTRT plus RS since January 1996 to July 2012. For each relapse, information on date of clinical/pathological recurrence, and pattern of disease presentation were retrieved. Post-relapse survival (PRS) was recorded from the date of recurrence to the date of death for disease or last seen. Survival probabilities were compared by the log rank test. Cox's regression model with stepwise variable selection was used for multivariate prognostic analysis for PRS. Within a median follow-up of 42 months, 75 recurrences (20.6%) and 54 disease-associated deaths (14.8%) were recorded. By analysing the pattern of relapse, most of the recurrences were outside the irradiated field (n=43, 57.3%) and the most frequently observed site was visceral (n=16, 21.3%). Among the parameters of the recurrence associated with PRS including the pattern of recurrence, the size of recurrence, SCC-Ag serum levels at recurrence, and secondary radical surgery, only the last one retained an independent predictive role in reducing the risk of death (p=0.037). The feasibility of secondary radical resection positively impacts on PRS of LACC patients submitted to multimodality primary treatments. Copyright © 2015. Published by Elsevier Inc.
    Gynecologic Oncology 05/2015; DOI:10.1016/j.ygyno.2015.04.035 · 3.69 Impact Factor
  • Gynecologic Oncology 05/2015; 138:1-2. DOI:10.1016/j.ygyno.2015.04.017 · 3.69 Impact Factor
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    ABSTRACT: To compare prognosis of advanced epithelial ovarian cancer (AEOC) patients based on where the first surgical assessment was performed. Retrospective analysis of primary AEOC patients was performed and three groups were formed based on where the decision of primary treatment was taken: Internal, if the decision was carried out at our Institution (PDS (Primary Debulking Surgery), I-IDS (Internal-Interval Debulking Surgery)) and Referred in case women were referred after neoadjuvant chemotherapy (NACT) from other Centers (R-IDS (Referred-Interval Debulking Surgery)). Among 573 AEOC, 279 (48.7%) were PDS and 294 (51.3%) IDS. In particular, 134 of 294 (45.6%) were R-IDS and 160 (54.4%) were I-IDS. Median progression-free survival (PFS) was 26 months in PDS, 14 months in I-IDS and 17 months in R-IDS. The difference was statistically significant (p<0.05) among all groups. IDS can represent a suitable approach only when the first complete debulking is not achievable in a tertiary referral hospital. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.
    Anticancer research 05/2015; 35(5):3027-32. · 1.87 Impact Factor
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    ABSTRACT: To evaluate the safety and feasibility of the new robotic TELELAP ALF-X platform in a heterogeneous series of gynecological procedures. Between September 2013 and May 2014, 146 patients were enrolled in this Phase II study trial. Patients with presumed benign or borderline adnexal disease, and benign and early stage malignant uterine disease were prospectively included. Median age was 52 years (range 19-79 years), and median BMI was 23.7 (range 17.3-34.0 kg/m(2)). Sixty-two patients (32.5 %) underwent mono/bilateral salpingo-oophorectomy or cyst removal (Group A), four patients (2.7 %) myomectomy (Group B), 46 patients (31.5 %) total hysterectomy (Group C), and 34 (23.3 %) endometrial cancer staging (Group D). Median docking time was 7 min (range 3-36). Median OT was 35 min (range 17-145) in the Group A, 40 min (range 10-50) in the Group B, 133 min (range 58-320) in the Group C, and 160 min (range 69-290) in the Group D. Reduction in OT over the study period for hysterectomy (p < 0.001) and adnexal surgery (p < 0.002) was observed. We registered two laparoscopic conversion (3.2 %) in the Group A and two (4.3 %) in the Group C. In the Group D, we showed one (2.9 %) laparoscopic and two (5.8 %) laparotomic conversions. One patient (2.17 %) in the Group C was readmitted in the early postoperative period for severe vaginal bleeding. We report the first series of a novel robotic approach for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, TELELAP ALF-X is feasible and safe. Further studies are mandatory to define the benefits, advantages, and costs of this new robotic approach with respect to others minimally invasive approaches.
    Surgical Endoscopy 04/2015; DOI:10.1007/s00464-015-4187-9 · 3.31 Impact Factor
  • Gynecologic Oncology 04/2015; 137:133-134. DOI:10.1016/j.ygyno.2015.01.332 · 3.69 Impact Factor
  • Gynecologic Oncology 04/2015; 137:134. DOI:10.1016/j.ygyno.2015.01.333 · 3.69 Impact Factor
  • Gynecologic Oncology 04/2015; 137:147-148. DOI:10.1016/j.ygyno.2015.01.369 · 3.69 Impact Factor
  • Gynecologic Oncology 04/2015; 137. DOI:10.1016/j.ygyno.2015.01.069 · 3.69 Impact Factor
  • Gynecologic Oncology 04/2015; 137:115. DOI:10.1016/j.ygyno.2015.01.285 · 3.69 Impact Factor
  • Gynecologic Oncology 04/2015; 137. DOI:10.1016/j.ygyno.2015.01.006 · 3.69 Impact Factor
  • Gynecologic Oncology 04/2015; 137:125. DOI:10.1016/j.ygyno.2015.01.312 · 3.69 Impact Factor
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    ABSTRACT: In this study we analyzed perioperative outcomes of Laparo-Endoscopic Single-Site (LESS) hysterectomy in obese and non-obese women. feasibility and perioperative outcomes of Laparo-Endoscopic Single-Site (LESS) hysterectomy in obese and non-obese women. multicentric retrospective case-control study . Canadian Task Force II-2 SETTING: Catholic University of the Sacred Heart and National Cancer Institute "Regina Elena" (Rome, Italy), Massachusetts General Hospital (Boston, USA), and Johns Hopkins Hospital, Baltimore (USA). From July 2009 to April 2013, 120 women underwent LESS hysterectomy. Five women (8%) were excluded from the analysis. The remaining 115 women were divided into two groups: obese (n=43, BMI ≥ 30 kg/m2) and non-obese (n=72, BMI < 30 kg/m2). Totale LESS hysterectomies for malignant and pre-malgnat uterine disease or at least for prophylactic intent were performed. No statistical differences regarding perioperative outcomes were observed between the two groups. Conversion to standard laparoscopy occurred in 2 obese (5%) and 2 (5%) non-obese women (p = 0.62). Conversion to laparotomy occurred in 1 obese (2.3%) and 3 (4.2%) non-obese women (p = 0.212). Median operative time was 115 minutes (range 48-300) in obese and 114 minutes (range 55-342) in non-obese women (p = 0.787). Intraoperative complication rate was 11.6% and 9.6% in obese and non-obese women, respectively (p = 0.712). The early postoperative complication rate was 6.9% in obese and 4.1% in non-obese women (p = 0.516). Despite the fact that the present analysis was performed in a relatively small group of patients, this study suggests that obesity (BMI ≥ 30) does not preclude successful completion of total LESS hysterectomy. Further prospective studies are required to confirm these preliminary data and to clarify potential advantages and disadvantages of LESS in obese women. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.
    Journal of Minimally Invasive Gynecology 12/2014; 22(3). DOI:10.1016/j.jmig.2014.12.008 · 1.58 Impact Factor
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    ABSTRACT: to compare the peri-operative outcomes of minimally invasive secondary cytoreduction surgery (SCS) plus HIPEC versus open surgery plus HIPEC in a group of platinum sensitive advanced epithelial ovarian cancer (AEOC) patients with isolated relapse.DesignRetrospective cohort study (Canadian Task Force classification II-2)SettingDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome.PatientsWe selected 22 patients, with a peritoneal cancer index (PCI) value 2. The laparoscopic group is composed by 11 patients underwent laparoscopic/robotic complete cytoreduction + HIPEC while laparotomic group is composed by 11 patients underwent complete laparotomic cytoreduction + HIPEC.InterventionsMinimally invasive surgery (MIS) group were platinum sensitive single recurrent ovarian cancer patients undergoing either laparoscopic or robotic complete secondary cytoreduction + HIPEC, while open group were women with similar clinical characteristics undergoing complete secondary cytoreduction + HIPEC by laparotomy.Measurements and main resultsThe median operative time, calculated from the skin incision to the end of SCS (i.e. excluding HIPEC phase) was 125 minutes (range 95-150 min) in the MIS group and 295 (range 180-420 min) in the open group (p=0.001), with a median estimated blood loss of 50 ml (range 50-100) and 500 ml (range 50-1300) respectively (p=0.025). The median length of hospital stay was 4 days (range 3-17) in the MIS group and 8.5 days (range 4-30) in the open group (p=0.002). No statistically significant differences were registered in terms of intra- and post-operative complications between the two groups.Conclusion The minimally invasive approach for SCS + HIPEC is safe and efficient in terms of toxicity and post-operative outcomes for single isolated relapse. HIPEC should not be considered as major contraindications to a minimally invasive approach.
    Journal of Minimally Invasive Gynecology 11/2014; 22(3). DOI:10.1016/j.jmig.2014.11.008 · 1.58 Impact Factor
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    ABSTRACT: Purpose This prospective, phase 2 study aimed at assessing the efficacy of accelerated fractionation radiation therapy by concomitant boosts (CBs) associated with chemoradiation therapy (CRT) of the whole pelvis, in improving the rate of pathological complete response (pCR) to treatment in patients with International Federation of Gynaecology and Obstetrics (FIGO) stage IB2-IVA locally advanced cervical cancer. Methods and Materials Neoadjuvant CRT included conformal irradiation of the whole pelvis with a total dose of 39.6 Gy (1.8 cGy/fraction, 22 fractions), plus additional irradiation of primary tumor and parametria with 10.8 Gy administered with CBs (0.9 cGy/fraction, 12 fractions, every other day). Concomitant chemotherapy included cisplatin (20 mg/m2, days 1-4 and 26-30 of treatment), and capecitabine (1300 mg/m2/daily, orally) during the first 2 and the last 2 weeks of treatment. Radical hysterectomy plus pelvic with or without aortic lymphadenectomy was performed within 6 to 8 weeks from CRT. Toxicity was recorded according to Radiation Therapy Oncology Group toxicity criteria and Chassagne grading system. Based on the Simon design, 103 cases were required, and the regimen would be considered active if >45 pCR were registered (α error = 0.05; β error = 0.1). Results pCR was documented in 51 cases (50.5%), and the regimen was considered active, according to the planned statistical assumptions. At median follow-up of 36 months (range: 7-85 months), the 3-year local failure rate was 7%, whereas the 3-year disease-free and overall survival rates were 73.0% and 86.1%, respectively. Grade 3 leukopenia and neutropenia were reported in only 1 and 2 cases, respectively. Gastrointestinal toxicity was always grade 1 or 2. Conclusions Addition of CBs in the accelerated fractionation modality to the whole pelvis chemoradiation followed by radical surgery results in a high rate of pathologically assessed complete response to CRT and a very encouraging local control rate, with acceptable toxicity.
    International journal of radiation oncology, biology, physics 11/2014; 90(4):778–785. DOI:10.1016/j.ijrobp.2014.07.033 · 4.18 Impact Factor
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    ABSTRACT: Study Objective To compare the perioperative outcome of laparoendoscopic single-site (LESS-RH) and minilaparoscopic radical hysterectomy (mLPS-RH). Design Retrospective multicenter study (Canadian Task Force Classification II-2). Setting Early stage cervical cancer. Patients Forty-six patents with FIGO stage IA2-IB1/IIA1 cervical cancer were included. Nineteen patients (41.3%) received LESS-RH, and 27 cases (58.7%) mLPS-RH. Pelvic lymph node dissection (PLND) was performed in all patients of cases. Interventions In the LESS-RH group all surgical procedures were performed through single umbilical multichannel port. In the mLPS group, RH was completed using a 5-mm umbilical optical trocar, and three additional 3-mm ancillary trocars placed suprapubically, and in the left/right lower abdominal regions. Measurements and Main Results There was no difference in clinic-pathological characteristics at the time of diagnosis between the LESS-RH and mLPS-RH groups. Median operative time was 270 (149-380) minutes in LESS-RH and 180 (90-240) minutes in the mLPS-RH group (p value=0.001). No further differences were detected in terms of type of RH, number of lymph nodes removed, or perioperative outcomes between the two groups. Conversion to laparotomy occurred in one patient (5.3%) in the LESS-RH group, following external iliac vein injury. Furthermore, in another woman treated with LESS approach, conversion to standard laparoscopy was required due to truncal obesity. In the mLPS-RH group, no conversions were observed, but reoperation for repair of a ureteral injury occurred. The percentage of patients discharged one day after surgery was significantly higher in the LESS-RH (57.9%), compared to mLPS-RHgroup (25.0%; p value=0.030). After a median follow-up of 27 months (9-73) only one patient, treated with mLPS-RH, experienced pelvic recurrence and died of disease. Conclusions Both LESS-RH and mLPS-RH are feasible ultra minimally invasive approaches for completion of RH plus PLND. Further technical improvements are required to allow a wider diffusion of these techniques for more complex procedures.
    Journal of Minimally Invasive Gynecology 11/2014; 21(6). DOI:10.1016/j.jmig.2014.04.008 · 1.58 Impact Factor
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    ABSTRACT: The aim of this study was to verify possible differences in terms of perioperative outcomes and complications between mini-laparoscopic radical hysterectomy with lymphadenectomy (mLRH) and robotic radical hysterectomy with lymphadenectomy (RRH) in patients with early cervical cancer (ECC). In this retrospective study, thirty women with early stage cervical cancer who underwent mini-laparoscopic radical hysterectomy plus lymphadenectomy (mLRH) were compared with a cohort of thirty women who underwent robotic multiport radical hysterectomy (RRH). The study involved patients, between August 2010 and December 2012, from three Italian institutions: National Cancer Institute of Rome, University of Insubria, Varese, and the Catholic University of the Sacred Heart of Rome. No significant differences between groups were observed in terms of age, BMI, previous abdominal surgery or FIGO stage. Operative time, blood loss, need of blood transfusion, risk of intra- and post-operative complications, and lymph nodes yield were similar between mLRH and RRH in patients with ECC. The median length of hospital stay was 2 days in the mLRH group and 3 days in the RRH group (p < 0.05). The few differences we registered do not seem clinically relevant, thus making the two procedures comparable. The decision on how to gain best access for radical hysterectomy considers the surgeon's skill and experience with the different possible approaches. Further randomized trials are needed to determine whether mini-laparoscopic techniques truly offer any advantages. Copyright © 2014 Elsevier Ltd. All rights reserved.
    European Journal of Surgical Oncology 10/2014; 41(1). DOI:10.1016/j.ejso.2014.10.048 · 2.89 Impact Factor

Publication Stats

2k Citations
572.02 Total Impact Points


  • 1999–2015
    • Catholic University of the Sacred Heart
      • • School of Obstetrics and Gynecology
      • • School of Oncology
      Milano, Lombardy, Italy
  • 1990–2015
    • Università degli Studi di Perugia
      • Department of Cellular and Environmental Biology
      Perugia, Umbria, Italy
  • 2013
    • Columbus-Gemelli University Hospital
      Roma, Latium, Italy
  • 1995–2012
    • The Catholic University of America
      Washington, Washington, D.C., United States
  • 2009
    • Ospedale Sacro Cuore di Gesù
      Benevento, Campania, Italy
  • 2006
    • Gynecologic Oncology Group
      Buffalo, New York, United States
  • 2003–2006
    • Sacred Heart University
      Феърфилд, Connecticut, United States
  • 2001
    • Jackson Memorial Hospital
      Miami, Florida, United States