11 results on '"Falconer, H"'
Search Results
2. ESGE/ESGO/SERGS consensus statement on surgical steps in minimally invasive surgery in gynecologic oncology: transperitoneal and extraperitioneal approach for paraaortic lymphadenectomy.
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Rovira R, Mereu L, Planchamp F, Falconer H, El-Balat A, Barahona M, Fagotti A, Querleu D, and Taskiran C
- Abstract
Introduction: Assessment of retroperitoneal nodes is an important part of the surgical staging of gynecologic cancers. Although pelvic and paraaortic lymphadenectomy have been widely described by different authors, there is little consensus on the description of the different surgical steps for each procedure. An Intergroup Committee on Onco-Gyn Minimally Invasive Surgery has been established with members of the European Society for Gynecological Endoscopy (ESGE), European Society of Gynaecological Oncology (ESGO) and the Society of European Robotic Gynaecological Surgery (SERGS). The Intergroup Committee has various objectives: writing down a surgical description of the technique, which will be assessed by a group of experts following a formal consensus method and developing a specific Objective Structured Assessment of Technical Skills (OSATS) scale for each procedure., Methods: A hierarchical task analysis was conducted by a working group of eight experts from the three societies in order to identify the surgical steps of transperitoneal and extraperitoneal approach in paraaortic lymphadenectomy. The selection of the definitive surgical steps was confirmed by a group of 19 experts from the different societies, following a formal consensus method. Two rounds of Delphi panel rating were considered necessary for achieving an agreement. The consensus agreement identified 29 surgical steps in transperitoneal and 17 surgical steps in extraperitoneal approach to complete a paraaortic lymphadenectomy. Once the description of the procedure and the consensus were established, an Objective specific Scale for the Assessment of Technical Skills for Paraaortic lymphadenectomy (PA-OSATS) in the transperitoneal and extraperitoneal approach was developed., Results: In the first round of rating we found that 28 steps out of 29 in the transperitoneal approach and 13 out of 17 in the extraperitoneal approach did not reach a strong degree of agreement. They were reformulated based on comments made by the experts, and submitted to a second round of rating and this finally achieved an agreement., Conclusion: We defined a list of surgical steps in transperitoneal and extraperitoneal approach in paraaortic lymphadenectomy and a specific PA-OSATS scale for these procedures. This tool will be useful for teaching, assessing and standardizing this surgical procedure., Competing Interests: Competing interests: AEB has reported grants for travelling from Olympus; AF has reported advisory boards for Johnson & Johnson, Fondazione Internazionale Menarini and Oncoinvent, research support from AstraZeneca/MSD, and speakers bureau for GlaxoSmithKline and Covidien/Medtronic; RR, LM, FP, HF, MB, DQ, and CT have reported no conflicts of interest., (© IGCS and ESGO 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)
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- 2024
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3. Assessing minimally invasive simple hysterectomy in low risk cervical cancer: set up for the LASH trial.
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Bizzarri N, Abu-Rustum NR, Plante M, Ramirez PT, Chiva L, Falconer H, Cibula D, Querleu D, Fanfani F, Fagotti A, and Scambia G
- Abstract
After the publication of the Laparoscopic Approach to Cervical Cancer (LACC) trial, open surgery has become the standard approach for radical hysterectomy in early stage cervical cancer. Recent studies assessed the role of a non-radical approach in low risk cervical cancer and showed no survival difference compared with radical hysterectomy. However, there is a gap in knowledge regarding the oncologic outcomes of minimally invasive simple hysterectomy in low risk cervical cancer. This review offers an overview of the current evidence on the role of the minimally invasive approach in low risk cervical cancer and raises the need for a new clinical trial in this setting., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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4. Radical trachelectomy.
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Segarra-Vidal B, Persson J, and Falconer H
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- Female, Humans, Trachelectomy methods
- Abstract
Radical trachelectomy is the 'cornerstone' of fertility-sparing surgery in patients with early-stage cervical cancer wishing to preserve fertility. Growing evidence has demonstrated the oncologic safety and subsequent favorable pregnancy outcomes in well-selected cases. In the absence of prospective trials, the decision on the appropriate surgical approach (vaginal, open, or minimally invasive surgery) should be based on local resources and surgeons' preferences. Radical trachelectomy has the potential to preserve fertility in a large proportion of women with early-stage cervical cancer. However, prematurity and premature rupture of membranes are common obstetric complications after radical trachelectomy for cervical cancer. A multidisciplinary approach is crucial to optimize the balance between oncologic and obstetric outcomes. The purpose of this review is to provide an updated overview of the technical, oncologic, and obstetric aspects of radical trachelectomy., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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5. Development of a surgical competency assessment tool for sentinel lymph node dissection by minimally invasive surgery for endometrial cancer.
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Moloney K, Janda M, Frumovitz M, Leitao M, Abu-Rustum NR, Rossi E, Nicklin JL, Plante M, Lecuru FR, Buda A, Mariani A, Leung Y, Ferguson SE, Pareja R, Kimmig R, Tong PSY, McNally O, Chetty N, Liu K, Jaaback K, Lau J, Ng SYJ, Falconer H, Persson J, Land R, Martinelli F, Garrett A, Altman A, Pendlebury A, Cibula D, Altamirano R, Brennan D, Ind TE, De Kroon C, Tse KY, Hanna G, and Obermair A
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- Adult, Clinical Competence, Consensus, Delphi Technique, Female, Humans, Male, Middle Aged, Minimally Invasive Surgical Procedures methods, Sentinel Lymph Node Biopsy standards, Surveys and Questionnaires, Endometrial Neoplasms surgery, Gynecology methods, Sentinel Lymph Node Biopsy methods
- Abstract
Introduction: Sentinel lymph node dissection is widely used in the staging of endometrial cancer. Variation in surgical techniques potentially impacts diagnostic accuracy and oncologic outcomes, and poses barriers to the comparison of outcomes across institutions or clinical trial sites. Standardization of surgical technique and surgical quality assessment tools are critical to the conduct of clinical trials. By identifying mandatory and prohibited steps of sentinel lymph node (SLN) dissection in endometrial cancer, the purpose of this study was to develop and validate a competency assessment tool for use in surgical quality assurance., Methods: A Delphi methodology was applied, included 35 expert gynecological oncology surgeons from 16 countries. Interviews identified key steps and tasks which were rated mandatory, optional, or prohibited using questionnaires. Using the surgical steps for which consensus was achieved, a competency assessment tool was developed and subjected to assessments of validity and reliability., Results: Seventy percent consensus agreement standardized the specific mandatory, optional, and prohibited steps of SLN dissection for endometrial cancer and informed the development of a competency assessment tool. Consensus agreement identified 21 mandatory and three prohibited steps to complete a SLN dissection. The competency assessment tool was used to rate surgical quality in three preselected videos, demonstrating clear separation in the rating of the skill level displayed with mean skills summary scores differing significantly between the three videos (F score=89.4; P<0.001). Internal consistency of the items was high (Cronbach α=0.88)., Conclusion: Specific mandatory and prohibited steps of SLN dissection in endometrial cancer have been identified and validated based on consensus among a large number of international experts. A competency assessment tool is now available and can be used for surgeon selection in clinical trials and for ongoing, prospective quality assurance in routine clinical care., Competing Interests: Competing interests: AO reports grants and personal fees from Surgical Performance PTY LTD, grants from Medtronic, outside the submitted work; NRA-R reports grants from Stryker/Novadaq, outside the submitted work; MF reports grants from Astra Zeneca, grants from Tesaro/GSK, grants and personal fees from Stryker, grants from Biom’Up, outside the submitted work; ML reports Ad hoc consulting from Intuitive Surgical, serves on advisory board for Ethicon, partial grant support from NIH/NCI Memorial Sloan Kettering Cancer Center Support, outside the submitted work; TEI reports personal fees from Medtronic, personal fees from Intuitive Surgical, outside the submitted work; RK reports personal fees from Intuitive Surgical Inc., personal fees from Medtronic, personal fees from Medicaroid, outside the submitted work, and President of SERGS and Council Member of IGCS; HF reports personal fees from Intuitive Surgical Inc, outside the submitted work; JP reports personal fees from Intuitive Surgical Inc., outside the submitted work; AA reports grants and a site PI, speaker fees and serves on advisory board for Astrazeneca, serves on the advisory board for GSK, grants and grats and site Co-PI and speaker fees from Merck, speaker fees from Sanofi, grants from Pfizer, grants from Clovis, grants from CancerCare Manitoba Foundation, grants from Canadian Clinical Trials group, outside the submitted work., (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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6. Beyond oncologic outcomes: fertility and ovarian preservation as key priorities.
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Salvo G, Falconer H, and Pareja R
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- Female, Fertility Preservation standards, Humans, Ovarian Neoplasms therapy, Pregnancy, Pregnancy Complications, Neoplastic therapy, Fertility Preservation methods
- Abstract
Competing Interests: Competing interests: None declared.
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- 2021
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7. Pelvic sentinel lymph node biopsy in endometrial cancer-a simplified algorithm based on histology and lymphatic anatomy.
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Bollino M, Geppert B, Lönnerfors C, Falconer H, Salehi S, and Persson J
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- Adult, Aged, Aged, 80 and over, Carcinoma, Endometrioid surgery, Coloring Agents, Endometrial Neoplasms surgery, Female, Humans, Indocyanine Green, Lymph Node Excision, Lymphatic System cytology, Lymphatic System pathology, Middle Aged, Neoplasm Grading, Neoplasm Staging, Sentinel Lymph Node surgery, Algorithms, Carcinoma, Endometrioid pathology, Endometrial Neoplasms pathology, Lymphatic System anatomy & histology, Sentinel Lymph Node pathology, Sentinel Lymph Node Biopsy methods
- Abstract
Objective: To achieve the full potential of sentinel lymph node (SLN) detection in endometrial cancer, both presumed low- and high-risk groups should be included. Perioperative resource use and complications should be minimized. Knowledge on distribution and common anatomical sites for metastatic SLNs may contribute to optimizing the concept while maintaining sensitivity. Proceeding from previous studies, simplified algorithms based on histology and lymphatic anatomy are proposed., Methods: Data on mapping rates and locations of pelvic SLNs (metastatic and non-metastatic) from two previous prospective SLN studies in women with endometrial cancer were retrieved. Cervically injected indocyanine green was used as a tracer and an ipsilateral re-injection was performed in case of non-display of the upper and/or lower paracervical pathways. A systematic surgical algorithm was followed with clearly defined SLNs depicted on an anatomical chart. In high-risk endometrial cancer patients, removal of SLNs was followed by a pelvic and para-aortic lymphadenectomy., Results: 423 study records were analyzed. The bilateral mapping rates of the upper and lower paracervical pathways were 88.9% and 39.7%, respectively. 72% of all SLNs were typically positioned along the upper paracervical pathway (interiliac and/or proximal obturator fossa) and 71 of 75 (94.6%) of pelvic node positive women had at least one metastatic SLN at either of these positions. Women with grade 1-2 endometroid cancers (n=275) had no isolated metastases along the lower paracervical pathway compared with two women with high-risk histologies (n=148)., Conclusion: SLNs along the upper paracervical pathway should be identified in all endometrial cancer histological subtypes; removal of nodes at defined typical positions along the upper paracervical pathway may replace a site-specific lymphadenectomy in case of non-mapping despite tracer re-injection. Detection of SLNs along the lower paracervical pathway can be restricted to high-risk histologies and a full pre-sacral lymphadenectomy should be performed in case of non-display., Competing Interests: Competing interests: JP and CL have received honoraria from Intuitive Surgical for proctoring and lectures in robot assisted surgery, and HF has received honoraria from Intuitive Surgical and Medtronics for similar services., (© IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2020
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8. Robot-assisted approach to cervical cancer (RACC): an international multi-center, open-label randomized controlled trial.
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Falconer H, Palsdottir K, Stalberg K, Dahm-Kähler P, Ottander U, Lundin ES, Wijk L, Kimmig R, Jensen PT, Zahl Eriksson AG, Mäenpää J, Persson J, and Salehi S
- Subjects
- Disease-Free Survival, Female, Humans, Hysterectomy adverse effects, Laparoscopy adverse effects, Laparoscopy methods, Lymph Node Excision adverse effects, Lymph Node Excision methods, Neoplasm Staging, Prospective Studies, Robotic Surgical Procedures adverse effects, Treatment Outcome, Uterine Cervical Neoplasms pathology, Clinical Protocols, Hysterectomy methods, Robotic Surgical Procedures methods, Uterine Cervical Neoplasms surgery
- Abstract
Background: Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival., Primary Objective: To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy., Study Hypothesis: Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes., Trial Design: Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden., Major Inclusion/exclusion Criteria: Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years., Primary Endpoint: Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer., Sample Size: The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1-β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients., Estimated Dates for Completing Accrual and Presenting Results: Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter., Trial Registration: The trial is registered at ClinicalTrials.gov (NCT03719547)., Competing Interests: Competing interests: HF, RK, and JP are proctors for Intuitive Surgical Inc., (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2019
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9. International radical trachelectomy assessment: IRTA study.
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Salvo G, Ramirez PT, Leitao M, Cibula D, Fotopoulou C, Kucukmetin A, Rendon G, Perrotta M, Ribeiro R, Vieira M, Baiocchi G, Falconer H, Persson J, Wu X, Căpilna ME, Ioanid N, Mosgaard BJ, Berlev I, Kaidarova D, Olawaiye AB, Liu K, Nobre SP, Kocian R, Saso S, Rundle S, Noll F, Tsunoda AT, Palsdottir K, Li X, Ulrikh E, Hu Z, and Pareja R
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- Disease-Free Survival, Female, Fertility Preservation methods, Humans, Minimally Invasive Surgical Procedures methods, Neoplasm Staging, Retrospective Studies, Robotic Surgical Procedures methods, Uterine Cervical Neoplasms pathology, Trachelectomy methods, Uterine Cervical Neoplasms surgery
- Abstract
Background: Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy., Primary Objective: To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy., Study Hypothesis: We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach., Study Design: This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data., Inclusion Criteria: Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both)., Exclusion Criteria: Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach., Primary Endpoint: The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy., Sample Size: An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2019
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10. Lymphedema, serious adverse events, and imaging 1 year after comprehensive staging for endometrial cancer: results from the RASHEC trial.
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Salehi S, Åvall-Lundqvist E, Brandberg Y, Johansson H, Suzuki C, and Falconer H
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- Adult, Aged, Female, Follow-Up Studies, Humans, Lymphedema diagnosis, Middle Aged, Neoplasm Staging, Quality of Life, Endometrial Neoplasms pathology, Endometrial Neoplasms surgery, Laparoscopy adverse effects, Lymphedema etiology, Postoperative Complications, Robotic Surgical Procedures adverse effects
- Abstract
Background and Objectives: In the Robot Assisted Surgery for High Risk Endometrial Cancer (RASHEC) trial, patients with high-risk endometrial cancer were randomly assigned to robot-assisted laparoscopic surgery (RALS) or laparotomy for pelvic and infrarenal para-aortic lymph node dissection. We here report on self-reported lower limb lymphedema (LLL), lymphocyst formation, ascites, and long-term serious adverse events 12 months after surgery., Patients and Methods: Patients were enrolled between 2013 and 2016, and 96 patients were included in the per protocol analysis, evenly distributed between RALS and laparotomy. Self-reported LLL was recorded using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for endometrial cancer-EN24, assessed before and 12 months after surgery. Computed tomography was assessed at baseline, 3, and 12 months. Medical charts were reviewed for serious adverse events and hospital admissions 31 to 365 days after surgery., Results: At 12 months after laparotomy and RALS, 61% and 50% patients, respectively, reported LLL (p = 0.31). In univariate analysis, the mean score of LLL at 12 months was significantly higher for laparotomy than for RALS (p < 0.05) and for those without abdominal drainage (p = 0.02), but was not independently associated with LLL in the multivariate analysis. Imaging showed no significant difference in lymphocyst formation or ascites between surgical modalities. No difference was found in serious adverse events and admissions to hospital for any reason. There was no agreement between lymphocyst formation or ascites and self-reported LLL., Conclusion: Follow-up 1 year after comprehensive surgical staging for high-risk endometrial cancer showed no differences in self-reported LLL, findings on imaging, or SAE between laparotomy and robot-assisted surgery., Competing Interests: Competing interests: SS, EÅ-L, YB, CS, HJ declare no conflict of interest in regard to this paper. HF is a proctor for Intuitive Surgical., (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2019
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11. Letter to the Editor on the "European Society of Gynaecologic Oncology Quality Indicators for Advanced Ovarian Cancer Surgery" by Querleu et al, Int J Gynecol Cancer 2016;26: 1354-1363.
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Salehi S, Hjerpe E, and Falconer H
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- Cytoreduction Surgical Procedures methods, Female, Gynecologic Surgical Procedures methods, Health Services Accessibility, Humans, Ovarian Neoplasms diagnosis, Ovarian Neoplasms pathology, Practice Guidelines as Topic, Cytoreduction Surgical Procedures standards, Gynecologic Surgical Procedures standards, Ovarian Neoplasms surgery
- Published
- 2018
- Full Text
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