0000000000126229

AUTHOR

Giuseppe Vizzielli

0000-0002-2424-2691

Robotic Total Mesometrial Resection versus Laparoscopic Total Mesometrial Resection in Early Cervical Cancer: A Case-Control Study

Abstract Study Objective To report our experience with robotic total mesometrial resection (R-TMMR) comparing perioperative results with a series of laparoscopic total mesometrial resections (L-TMMRs). Design Multicenter retrospective case-control study (Canadian Task Force classification II-2). Setting Catholic University of the Sacred Heart of Rome (Italy) and Campobasso (Italy). Patients From July 2013 to August 2015 all cervical cancer patients with preoperative FIGO stage IA2 to IB1 were assessed at preoperative magnetic resonance imaging scan and clinically confirmed by investigation under anesthesia, complying strictly with the FIGO criteria. Surgical and postsurgical data of the TMM…

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Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Background: Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods: This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, r…

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Indocyanine Green to Assess Vascularity of Ileal Conduit Anastomosis During Pelvic Exenteration for Recurrent/Persistent Gynecological Cancer: A Pilot Study

IntroductionPelvic exenteration performed for recurrent/persistent gynecological malignancies has been associated with urological short- and long-term morbidity due to altered vascularization of tissues for previous radiotherapy. The aims of the present study were to describe the use of intravenous indocyanine green (ICG) to assess vascularity of urinary diversion (UD) after pelvic exenteration for gynecologic cancers, to evaluate the feasibility and safety of this technique, and to assess the postoperative complications.MethodsProspective, observational, single-center, pilot study including consecutive patients undergoing anterior or total pelvic exenteration due to persistent/recurrent gy…

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Robotic Versus Laparoscopic Staging for Early Ovarian Cancer: A Case-Matched Control Study.

Abstract Study Objective To evaluate the feasibility, surgical outcome, and oncologic results observed after robotic staging compared with conventional laparoscopic staging for patients with early-stage ovarian cancer patients. Design A retrospective cohort study (Canadian Task Force classification II-2). Setting Catholic University of the Sacred Heart, Rome, Italy. Patients Ninety-six patients underwent minimally invasive staging for presumed stage I ovarian cancer; 32 underwent the robotic approach (cases), and 64 underwent the laparoscopic approach (controls). Measurements and Main Results There was no statistically significant difference between the 2 approaches with regard to final Fed…

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A laparoscopic risk-adjusted model to predict major complications after primary debulking surgery in ovarian cancer: A single-institution assessment

Abstract Objective To develop and validate a simple adjusted laparoscopic score to predict major postoperative complications after primary debulking surgery (PDS) in advanced epithelial ovarian cancer (AEOC). Methods From January 2006 to June 2015, preoperative, intraoperative, and post-operative outcome data from patients undergoing staging laparoscopy (S-LPS) before receiving PDS (n=555) were prospectively collected in an electronic database and retrospectively analyzed. Major complications were defined as levels 3 to 5 of MSKCC classification. On the basis of a multivariate regression model, the score was developed using a random two-thirds of the population (n=370) and was validated on …

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Influence of Intraperitoneal Dissemination Assessed by Laparoscopy on Prognosis of Advanced Ovarian Cancer: An Exploratory Analysis of a Single-Institution Experience

Purpose: The aim of this study was to investigate whether preoperative laparoscopic evaluation of the dissemination of disease may have an independent impact on survival in advanced epithelial ovarian cancer (AEOC).Methods: All AEOC women were submitted to staging laparoscopy before receiving primary debulking surgery (PDS) or neoadjuvant chemotherapy (NACT). All study women received a laparoscopic score (predictive index value [PIV]) and were stratified into three groups based on volume of disease: high tumor load (HTL) for PIV ≥8, intermediate tumor load (ITL) for PIV equal to 6 and 4, and low tumor load (LTL) for PIV 1 cm in 15 cases (9.1 %). When stratifying the whole population accordi…

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Laparoscopic radical hysterectomy in cervical cancer as total mesometrial resection (L-TMMR): A multicentric experience

Abstract Objective To analyze the feasibility of total mesometrial resection by laparoscopy (L-TMMR) in a multicentric series of early stage cervical cancer. Method We prospectively evaluated a consecutive series of cervical cancer patients with pre-operative FIGO stages IA2–IB1 at the Catholic University in Rome and in Campobasso and the Charite University in Berlin. All cases were assessed at pre-operative MRI scan and clinically confirmed by investigation under anesthesia, adhering strictly to the FIGO criteria. The surgical and post-surgical data were collected. Results 104 women with cervical cancer were admitted between July 2013 and August 2014 and among them 71 patients with pre-ope…

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Phase III randomised clinical trial comparing primary surgery versus neoadjuvant chemotherapy in advanced epithelial ovarian cancer with high tumour load (SCORPION trial): Final analysis of peri-operative outcome.

Abstract Objective To establishing whether neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) is superior primary debulking surgery (PDS) in terms of clinical outcome as well as peri-operative morbidity in advanced epithelial ovarian cancer (AEOC) endowed with high tumour load (HTL). Material and methods This is a single-Institution, superiority, randomised phase III trial enrolling supposed AEOC women. Patients considered pre-operatively eligible were triaged to staging laparoscopy to assess the predictive index (PI) of tumour load. All AEOC women with PI ≥ 8 or ≤ 12 (considered as HTL) were included. They were randomly assigned (1:1 ratio) to undergo either PDS f…

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8 A multicentric randomized trial to evaluate the role of uterine manipulator on laparoscopic/robotic hysterectomy for the treatment of low-risk endometrial cancer: the ROMANHY trial (NCT:02762214)

Background The role of the intrauterine manipulator in minimally invasive hysterectomy for endometrial cancer has been widely debated in terms of impact on the oncological outcomes. To date, definitive conclusions on the possible advantages and oncological safety of its use in endometrial cancer staging are still awaited. Objectives This randomized trial aimed to assess the role of the uterine manipulator in terms of oncological and perioperative outcomes in patients undergoing minimally invasive (laparoscopic/robotic) staging for presumed low-risk endometrial cancer. Study Design Enrolled patients were randomly allocated in two groups according to the use (Group A) or no use (Group B) of t…

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Peritoneal HPV‐DNA test in cervical cancer (PIONEER study): A proof of concept

The aim of this study was to investigate the prevalence of peritoneal human papillomavirus (HPV) infection in different clinical cervical cancer (CC) settings, and its association with potential clinical and/or histological factors. This is a single-center, prospective, observational study. Consecutive patients with newly diagnosed or recurrent/persistent CC, between March 2019 and April 2020, were included. A group of patients undergoing surgery for benign gynecological conditions was included as control group. All patients underwent HPV-DNA test in the cervix and in the peritoneal cavity simultaneously at time of surgery. Two-hundred seventy-two patients had cervical and peritoneal HPV te…

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Laparoscopic Total Mesometrial Resection (L-TMMR)

Abdominal radical hysterectomy and pelvic lymph node dis- section as introduced by Wertheim and Meigs [1–2] first in the beginning of the century is still regarded as “gold stan- dard” in the surgical treatment of the uterine cervix carci- noma, FIGO stages IA2-IB and IIA. The resection of the parametrial and paracervical tissues proposed by the conventional radical hysterectomy is based on a “centrifu- gal diffusion” from the center of the tumor on the direction of the parametrial (dorsal, lateral and ventral) highways. This imply a classic functional and ligament-focused view of the surgical anatomy.

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Is a Vaginectomy Enough or is a Pelvic Exenteration Always Required for Surgical Treatment of Recurrent Cervical Cancer? A Propensity-Matched Study.

Purpose: Reporting the perioperative and survival outcomes of vaginectomy with respect to a matched series of pelvic exenteration (PE) in women with isolated recurrent cervical cancer. Methods: The records of vaginal recurrent cervical cancer patients admitted at Fondazione Policlinico “Agostino Gemelli” IRCCS in Rome from January 2010 to June 2019 were retrospectively analyzed. A propensity-matched score analysis was performed by age, clinical stage, disease-free interval, and R0 resection. Postsurgical complications and survival rates were evaluated. Results: Fifteen women underwent vaginectomy, and 30 patients were submitted to PE. No statistical differences were observed between the two…

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Anatomical distribution of sentinel lymph nodes in patients with endometrial cancer: a multicenter study.

ObjectiveSentinel lymph node (SLN) mapping represents the standard approach in uterine confined endometrial cancer patients. The aim of this study was to evaluate the anatomical distribution of SLNs and the most frequent locations of nodal metastasis.MethodsThis was an observational retrospective multicenter study involving eight high volume gynecologic cancer centers in Italy. We reviewed 1576 patients with a histologically confirmed diagnosis of endometrial cancer from September 2015 to June 2020. All patients underwent total hysterectomy with salpingo-ophorectomy and SLN mapping.ResultsA total of 3105 SLNs were mapped and removed, 2809 (90.5%) of these were bilateral and 296 (9.5%) unila…

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336 Is a vaginectomy enough or is a pelvic exenteration always required for surgical treatment of recurrent cervical cancer?

Introduction No consensus has yet been reached on the best strategy for treatment of cervical cancer local recurrence. Vaginectomy could be a salvage treatment in selected patients. Methods The records of vaginal recurrent cervical cancer patients admitted at Fondazione Policlinico ‘Agostino Gemelli’ IRCCS in Rome from January 2010 to June 2019 were retrospectively analyzed. We reported perioperative and survival outcomes of vaginectomy with respect to a matched series of pelvic exenteration (PE). Results Fifteen women underwent vaginectomy and 30 patients were submitted to PE. No statistical differences were observed between the two groups at baseline characteristics. The vaginectomy proce…

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Surgical outcomes of diaphragmatic resection during cytoreductive surgery for advanced gynecological ovarian neoplasia: A randomized single center clinical trial - DRAGON.

Introduction: Ovarian cancer (OC) represent nearly 4% of gynecologic malignancies and it is often diagnosed at advanced stage. Diaphragmatic surgery, a fundamental step of advanced stage ovarian cancer (ASOC) debulking surgery, is associated with a high post-operative complication incidence, which is supposedly reduced with thoracostomy tube placement. We assessed the role of intra-operative thoracostomy tube placement, as a prevention measure for post-operative complications, after diaphragmatic resection. Methods: This was a single center prospective randomized trial. Ovarian cancer patients, who underwent mono-lateral diaphragmatic resection, were randomized 1:1 into two arms. Arm A incl…

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Robotic Radical Hysterectomy After Concomitant Chemoradiation in Locally Advanced Cervical Cancer: A Prospective Phase II Study

Study Objective To assess the feasibility of total robotic radical surgery (TRRS) in patients with locally advanced cervical cancer (LACC) who receive chemoradiation therapy (CT/RT). Design A prospective (preplanned) study of a nonrandomized controlled trial (Canadian Task Force classification level 2). Setting Catholic University of the Sacred Hearth, Rome, Italy. Patients Between September 2013 and January 2016, a total of 40 patients with LACC (Fédération Internationale de Gynécologie et d'Obstétrique stage IB2–III) were enrolled in the study. Interventions Robotic radical hysterectomy (RRH) plus pelvic and/or aortic lymphadenectomy was attempted within 6 weeks after CT/RT. The feasibili…

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Survival analyses from a randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer with high tumor load (SCORPION trial).

5516Background: Previous randomized multicenter trials determined that neoadjuvant chemotherapy (NACT) was non-inferior to primary debulking surgery (PDS) for both progression-free (PFS) and overal...

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Laparoscopic laterally extended pelvic resection for gynecological malignancies

Lateral isolated gynecological cancer infiltrating the pelvic side wall has been considered non-operable with a poor oncological outcome.[1][1] The development of the laterally extended endopelvic resection and surgical progress for disease, overcoming the endopelvic fascia infiltrating muscles and

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Surgery vs. chemotherapy for ovarian cancer recurrence: what is the best treatment option

Nowadays, the best treatment option for ovarian cancer recurrence is often subjective, can vary in the different centers and depend on personal experience. Arbeitsgemeinschaft Gynaekologische Onkologie (AGO)-DESKTOP studies have identified a population of patients who could benefit from secondary surgery. The results of the Gynecologic Oncology Group (GOG)-0213 study were recently published, which showed no advantage in terms of overall survival (OS) in patients with platinum-sensitive recurrent epithelial ovarian undergoing secondary cytoreductive surgery (SCS) compared to chemotherapy alone. Aim of this narrative review is to summarize the best aspects that can make ovarian cancer recurre…

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Out-of-the-box pelvic surgery including iliopsoas resection for recurrent gynecological malignancies: Does that make sense? A single-institution case-series

Abstract Objective To report morbidity and oncological outcomes in a consecutive series of lateral isolated recurrent gynecological cancer involving the pelvic side wall (PSW) including the iliopsoas muscle. Material and methods We retrospectively evaluated a consecutive series between 6/2013 and 12/2015 of lateral isolated recurrent gynecological malignancies treated with a lateral endopelvic resection (LEPR). LEPR was defined as an en-bloc lateral resection of a pelvic tumor with sidewall muscle, and/or bone, and/or major nerve, and/or major vascular structure. Post-surgical complications, quality of life (QoL) and survivals were computed. Results Seventy-four women with pelvic isolated r…

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What is the prognostic importance of lymphovascular space invasion in the absence of lymph node metastasis for early-stage endometrial cancer?

Objective: The aim of this study is to analyze the prognostic role of lymph-vascular space invasion (LVSI), evaluated in a semi-quantitative fashion on prognosis of early stage, low risk endometrial cancer (EC). Methods: We enrolled patients who underwent surgery for endometrial cancer between 2003 and 2018 in two referral cancer center. All patients had endometrioid EC, G1–G2, with myometrial invasion <50%, and no lymph-node involvement. LVSI was analyzed in a semi-quantitative way, according to a 3-tiered scoring system in absent, focal and substantial. Results: Among 524 patients, any positive LVSI was found in 57 patients (10.9%) with focal LVSI (n=35, 6.7%) and substantial LVSI (n=2…

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From palliation to cure: PIPAC for peritoneal malignancies

Introduction Systemic chemotherapy offers poor control over peritoneal disease, maybe as a consequence of restricted drug availability within the abdominal cavity. Locoregional chemotherapy may overcome these shortcomings but its administration is limited to a few patients with confined peritoneal spread. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) emerged in the last years as a novel method of intraperitoneal drug administration. Evidence acquisition We report a meta-analysis of published studies on PIPAC safety and pathological anti-tumoral efficacy on PC from various tumor entities, with the aim of providing more evidence to support further research. This systematic review a…

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ASO Authors Reflections: Vaginectomy as Surgical Treatment of Recurrent Cervical Cancer

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Protective Role of Conization Before Radical Hysterectomy in Early-Stage Cervical Cancer: A Propensity-Score Matching Study.

Purpose: The purpose of this study was to assess the prognostic role and the perioperative outcomes of conization performed before radical hysterectomy in early-stage cervical carcinoma. Methods: This multicenter, retrospective observational cohort study included patients with FIGO 2009 stage IB1 cervical carcinoma treated with radical hysterectomy between June 2004 and June 2019. Patients were divided into two groups according to conization before radical surgery. One-to-one case–control matching was used to adjust the baseline characteristics. Results: A total of 332 patients were included after propensity matching (166, 50% in each group). Twenty-four of 166 (14.4%) and 142 of 166 (85.6%…

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A Multicentric Randomized Trial to Evaluate the ROle of Uterine MANipulator on Laparoscopic/Robotic HYsterectomy for the Treatment of Early-Stage Endometrial Cancer: The ROMANHY Trial

ObjectiveThis prospective randomized trial aimed to assess the impact of the uterine manipulator in terms of lymph vascular space invasion (LVSI) in patients undergoing minimally invasive staging for early-stage endometrial cancer.MethodsIn this multicentric randomized trial, enrolled patients were randomly allocated in two groups according to the no use (arm A) or the use (arm B) of the uterine manipulator. Inclusion criteria were G1-G2 early-stage endometrial cancer at preoperative evaluation. The variables collected included baseline demographic characteristics, perioperative data, final pathology report, adjuvant treatment, and follow-up.ResultsIn the study, 154 patients (76 in arm A an…

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Hepatoceliac Lymph Node Involvement in Advanced Ovarian Cancer Patients: Prognostic Role and Clinical Considerations.

Background: The study aimed too investigate the rate of hepatoceliac lymph node (HCLN) involvement, as well as its association with clinicopathologic features, together with morbidity of HCLN resection and the prognostic impact of metastatic HCLN status on patients with advanced ovarian cancer (OC) undergoing cytoreductive surgery. Methods: All consecutive patients with stages 3c to 4 epithelial OC who underwent HCLN surgery from January 2010 to September 2016 were analyzed for surgical procedures, pathology, and oncologic outcomes. Results: During the study period, 85 patients underwent HCLN resection. Absence of visible tumor at the end of surgery was documented for 73 of the patients (85…

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Robotic versus laparoscopic radical hysterectomy in early cervical cancer: A case matched control study

Abstract Background This study aims at evaluating the feasibility, surgical outcome and oncological results observed after robotic radical hysterectomy (RH) compared to laparoscopy for patients with early stage cervical cancer (ECC) patients. Methods Between January 2010 and October 2016, 210 patients underwent RH for treatment of ECC: 70 underwent robotic approach (Cases), and 140 underwent laparoscopic approach (Controls). Results There was no statistically significant difference between the two approaches with regard to clinical patient characteristics and in terms of extent of RH and rate of pelvic and aortic lymphadenectomy. Operative time was significantly longer in the robotic versus…

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Role of Cytoreductive surgery in recurrent ovarian cancer

Ovarian cancer is the leading cause of death from gynecologic malignancy in western countries, primarily because over 60% of patients with ovarian cancer will experience disease recurrence. Primary cytoreductive surgery and combination chemotherapy are the cornerstones of the initial treatment for epithelial ovarian cancer. The management of recurrent ovarian cancer is less clear than that of primary disease. The management of recurrent ovarian cancer is largely based on systemic chemotherapy, with surgery being offered only in selected individuals. Despite this, the benefits of surgery has been shown in a meta-analysis by Bristow et al. where the survival is influenced by the completeness …

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351 Substantial lymph-vascular space invasion (LVSI) as predictor of distant relapse and poor prognosis in low-risk early stage endometrial cancer

Objective To evaluate the prognostic role of LVSI, evaluated in a semi-quantitative fashion on prognosis of early stage, low risk endometrial cancer (EC). Methods We enrolled patients who underwent surgery for EC between 2003 and 2018 in two referral cancer center. All patients had endometrioid EC, G1-G2, with myometrial invasion Results Among 524 patients, any positive LVSI was found in 57 patients (10.9%) with 6.7% (n=35) focal LVSI and 4.2% (n=22) substantial LVSI. Substantial LVSI was associated to higher rate of G2 (p Conclusions Substantial LVSI represents the strongest independent risk factor for decreased survival and distant relapse, indicating a role for potential hematogenous dis…

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Self-Reported Long-Term Autonomic Function After Laparoscopic Total Mesometrial Resection for Early-Stage Cervical Cancer: A Multicentric Study.

ObjectivesThis multicentric retrospective study investigates the early and long-term self-reported urinary, bowel, and sexual dysfunctions in early-stage cervical cancer patients who submitted to laparoscopic total mesometrial resection (L-TMMR), total laparoscopic radical hysterectomy, vaginal-assisted laparoscopic radical hysterectomy, and laparoscopic-assisted radical vaginal hysterectomy.MethodsCervical cancer patients, FIGO (International Federation of Gynecology and Obstetrics) stage IA2–IB1/IIA1 who submitted to nerve-sparing radical hysterectomy were recruited. Pelvic functions were assessed within 30 days (early outcome) and 12 months after surgery (long-term outcome).ResultsTwo hu…

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Definition of a dynamic laparoscopic model for the prediction of incomplete cytoreduction in advanced epithelial ovarian cancer: Proof of a concept

Abstract Objective To develop an updated laparoscopy-based model to predict incomplete cytoreduction (RT>0) in advanced epithelial ovarian cancer (AEOC), after the introduction of upper abdominal surgery (UAS). Patients and methods The presence of omental cake, peritoneal extensive carcinomatosis, diaphragmatic confluent carcinomatosis, bowel infiltration, stomach and/or spleen and/or lesser omentum infiltration, and superficial liver metastases was evaluated by staging laparoscopy (S-LPS) in a consecutive series of 234 women with newly diagnosed AEOC, receiving laparotomic PDS after S-LPS. Parameters showing a specificity≥75%, PPV≥50%, and NPV≥50% received 1 point score, with an additional…

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Minimally Invasive Pelvic Exenteration for Gynecologic Malignancies: A Multi-Institutional Case Series and Review of the Literature.

ABSTRACT Study Objective To assess the feasibility and efficacy of minimally invasive pelvic exenteration (MIPE) in a multi-institutional Italian case series of women with gynecologic cancer and a review of the literature. Design Retrospective cohort study (Canadian Task Force classification II-2). Setting Three Italian university/teaching hospitals: “Agostino Gemelli” Foundation University Hospital in Rome, "ARNAS Civico Di Cristina Benfratelli” Hospital in Palermo, and “Maggiore della Carita” Hospital in Novara. Patients We reviewed all consecutive cases with gynecologic malignancies in this multi-institutional setting recorded between March 2014 and June 2017. Women with primary or centr…

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Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850)

ObjectiveTo investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load.MethodsPatients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by int…

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