Pablo Padilla-Iserte1, Víctor Lago2, Carmen Tauste3, Berta Díaz-Feijoo4, Antonio Gil-Moreno5, Reyes Oliver6, Pluvio Coronado7, María Belén Martín-Salamanca8, Manuel Pantoja-Garrido9, Josefina Marcos-Sanmartin10, Juan Gilabert-Estellés11, Cristina Lorenzo12, Eduardo Cazorla13, Fernando Roldán-Rivas14, José Ramón Rodríguez-Hernández15, Lourdes Sánchez16, Juan Carlos Muruzábal3, David Hervas17, Santiago Domingo2. 1. Department of Gynaecologic Oncology, La Fe University and Polytechnic Hospital, Valencia, Spain. Electronic address: pablo_iserte@hotmail.com. 2. Department of Gynaecologic Oncology, La Fe University and Polytechnic Hospital, Valencia, Spain. 3. Department of Gynecologic Oncology, Complejo Hospitalario de Navarra, Pamplona, Spain. 4. Departments of Obstetrics and Neonatology, Institute Clinic of Gynecology, Hospital Clinic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain. 5. Gynecologic Oncology Unit, Department of Gynecology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain. 6. Department of Obstetrics and Gynecology, Endoscopy Unit, 12 de Octubre University Hospital, Madrid, Spain. 7. Women's Health Institute of the Hospital Clínico San Carlos, Madrid, Spain. 8. Department of Gynecology, Hospital Universitario de Getafe, Madrid, Spain. 9. Department of Gynecology and Obstetrics, University Hospital Virgen Macarena, Seville, Spain. 10. Departments of Obstetrics and Gynecology and Public Health, Hospital General Universitari D'Alacant, Alicante, Spain. 11. Department of Obstetrics and Gynecology, University General Hospital of Valencia, Valencia, Spain. 12. Department of Obstetrics and Gynecology, Hospital Nuestra Señora de la Calendaria, Tenerife, Spain. 13. Department of Obstetrics and Gynecology, Hospital Universitario de Torrevieja, Alicante, Spain. 14. Department of Obstetrics and Gynaecology, Clinico Lozano Blesa Hospital, Zaragoza, Spain. 15. Department of Obstetrics and Gynecology, Virgen de la Arrixaca University Clinical Hospital, El Palmar Murcia, Spain. 16. Department of Gynaecology and Obstetrics, Hospital General Universitario de Ciudad Real, Real, Spain. 17. Department of Biostatistics, Health Research Institute La Fe, Valencia, Spain.
Abstract
BACKGROUND: There are limited data available to indicate whether oncological outcomes might be influenced by the uterine manipulator, which is used at the time of hysterectomy for minimally invasive surgery in patients with endometrial cancer. The current evidence derives from retrospective studies with limited sample sizes. Without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience. OBJECTIVE: To evaluate the use of the uterine manipulator on oncological outcomes after minimally invasive surgery, for apparent early-stage endometrial cancer. STUDY DESIGN: We performed a retrospective multicentric study to assess the oncological safety of uterine manipulator use in patients with apparent early-stage endometrial cancer, treated with minimally invasive surgery. The type of manipulator, surgical staging, histology, lymphovascular space invasion, International Federation of Gynecology and Obstetrics stage, adjuvant treatment, recurrence, and pattern of recurrence were evaluated. The primary objective was to determine the relapse rate. The secondary objective was to determine recurrence-free survival, overall survival, and the pattern of recurrence. RESULTS: A total of 2661 women from 15 centers were included; 1756 patients underwent hysterectomy with a uterine manipulator and 905 without it. Both groups were balanced with respect to histology, tumor grade, myometrial invasion, International Federation of Gynecology and Obstetrics stage, and adjuvant therapy. The rate of recurrence was 11.69% in the uterine manipulator group and 7.4% in the no-manipulator group (P<.001). The use of the uterine manipulator was associated with a higher risk of recurrence (hazard ratio, 2.31; 95% confidence interval, 1.27-4.20; P=.006). The use of uterine manipulator in uterus-confined endometrial cancer (International Federation of Gynecology and Obstetrics [FIGO] I-II) was associated with lower disease-free survival (hazard ratio, 1.74; 95% confidence interval, 0.57-0.97; P=.027) and higher risk of death (hazard ratio, 1.74; 95% confidence interval, 1.07-2.83; P=.026). No differences were found regarding the pattern of recurrence between both groups (chi-square statistic, 1.74; P=.63). CONCLUSION: In this study, the use of a uterine manipulator was associated with a worse oncological outcome in patients with uterus-confined endometrial cancer (International Federation of Gynecology and Obstetrics I-II) who underwent minimally invasive surgery. Prospective trials are essential to confirm these results.
BACKGROUND: There are limited data available to indicate whether oncological outcomes might be influenced by the uterine manipulator, which is used at the time of hysterectomy for minimally invasive surgery in patients with endometrial cancer. The current evidence derives from retrospective studies with limited sample sizes. Without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience. OBJECTIVE: To evaluate the use of the uterine manipulator on oncological outcomes after minimally invasive surgery, for apparent early-stage endometrial cancer. STUDY DESIGN: We performed a retrospective multicentric study to assess the oncological safety of uterine manipulator use in patients with apparent early-stage endometrial cancer, treated with minimally invasive surgery. The type of manipulator, surgical staging, histology, lymphovascular space invasion, International Federation of Gynecology and Obstetrics stage, adjuvant treatment, recurrence, and pattern of recurrence were evaluated. The primary objective was to determine the relapse rate. The secondary objective was to determine recurrence-free survival, overall survival, and the pattern of recurrence. RESULTS: A total of 2661 women from 15 centers were included; 1756 patients underwent hysterectomy with a uterine manipulator and 905 without it. Both groups were balanced with respect to histology, tumor grade, myometrial invasion, International Federation of Gynecology and Obstetrics stage, and adjuvant therapy. The rate of recurrence was 11.69% in the uterine manipulator group and 7.4% in the no-manipulator group (P<.001). The use of the uterine manipulator was associated with a higher risk of recurrence (hazard ratio, 2.31; 95% confidence interval, 1.27-4.20; P=.006). The use of uterine manipulator in uterus-confined endometrial cancer (International Federation of Gynecology and Obstetrics [FIGO] I-II) was associated with lower disease-free survival (hazard ratio, 1.74; 95% confidence interval, 0.57-0.97; P=.027) and higher risk of death (hazard ratio, 1.74; 95% confidence interval, 1.07-2.83; P=.026). No differences were found regarding the pattern of recurrence between both groups (chi-square statistic, 1.74; P=.63). CONCLUSION: In this study, the use of a uterine manipulator was associated with a worse oncological outcome in patients with uterus-confined endometrial cancer (International Federation of Gynecology and Obstetrics I-II) who underwent minimally invasive surgery. Prospective trials are essential to confirm these results.
Authors: Salvatore Gueli Alletti; Emanuele Perrone; Camilla Fedele; Stefano Cianci; Tina Pasciuto; Vito Chiantera; Stefano Uccella; Alfredo Ercoli; Giuseppe Vizzielli; Anna Fagotti; Valerio Gallotta; Francesco Cosentino; Barbara Costantini; Stefano Restaino; Giorgia Monterossi; Andrea Rosati; Luigi Carlo Turco; Vito Andrea Capozzi; Francesco Fanfani; Giovanni Scambia Journal: Front Oncol Date: 2021-09-10 Impact factor: 6.244