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| Name | Class |
|---|---|
| Fundación Mutua Madrileña | OTHER |
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The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transperitoneal | Active Comparator | Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy. |
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| Extraperitoneal | Experimental | Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transperitoneal laparoscopic aortic lymphadenectomy | Procedure | Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lymph nodes | The number of lymph nodes (absolute number) is specified by the pathologist on histopathological analysis of the sample sent by the surgeon after surgical staging is realized (laparoscopic aortic lymphadenectomy). This variable is subdivided into: supra-mesenteric and infra-mesenteric. | After aortic lymphadenectomy is completed |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Total duration of surgery (from initial skin incision to end of skin suture), and total aortic lymphadenectomy time (time spent since the beginning of aortic lymphadenectomy to its completion). Metric: minutes. | At the time of the surgery |
| Intraoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Gil Moreno, M.D., PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Study Chair |
| Berta DÃaz Feijoo, M.D., PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Study Director |
| Jose Luis Sánchez, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| Alejandro Correa Paris, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| M. Assumpció Pérez-Benavente, M.D., PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| Silvia Cabrera DÃaz, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| Silvia Franco Camps, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| Oriol Puig Puig, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Bacelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20839058 | Background | Gil-Moreno A, Franco-Camps S, Cabrera S, Perez-Benavente A, Martinez-Gomez X, Garcia A, Xercavins J. Pretherapeutic extraperitoneal laparoscopic staging of bulky or locally advanced cervical cancer. Ann Surg Oncol. 2011 Feb;18(2):482-9. doi: 10.1245/s10434-010-1320-9. Epub 2010 Sep 14. | |
| 18538379 | Background |
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|
| Extraperitoneal laparoscopic aortic lymphadenectomy | Procedure | Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy. |
|
|
Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome. |
| At the time of surgery |
| Early Postoperative complications | Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome. | within 30 days after surgery |
| Late Postoperative complications | Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome. | past 30 days after surgery |
| Overall survival | Number of patients alive after surgery. | up to 3 years |
| Disease-free survival | Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease. | up to 3 years |
| Gil-Moreno A, Diaz-Feijoo B, Perez-Benavente A, del Campo JM, Xercavins J, Martinez-Palones JM. Impact of extraperitoneal lymphadenectomy on treatment and survival in patients with locally advanced cervical cancer. Gynecol Oncol. 2008 Sep;110(3 Suppl 2):S33-5. doi: 10.1016/j.ygyno.2008.03.024. Epub 2008 Jun 5. |
| 18365538 | Background | Gil-Moreno A, Maffuz A, Diaz-Feijoo B, Puig O, Martinez-Palones JM, Perez A, Garcia A, Xercavins J. Modified approach for extraperitoneal laparoscopic staging for locally advanced cervical cancer. J Exp Clin Cancer Res. 2007 Dec;26(4):451-8. |
| 16431320 | Background | Gil-Moreno A, Diaz-Feijoo B, Morchon S, Xercavins J. Analysis of survival after laparoscopic-assisted vaginal hysterectomy compared with the conventional abdominal approach for early-stage endometrial carcinoma: a review of the literature. J Minim Invasive Gynecol. 2006 Jan-Feb;13(1):26-35. doi: 10.1016/j.jmig.2005.08.013. |
| 18835020 | Background | Dowdy SC, Aletti G, Cliby WA, Podratz KC, Mariani A. Extra-peritoneal laparoscopic para-aortic lymphadenectomy--a prospective cohort study of 293 patients with endometrial cancer. Gynecol Oncol. 2008 Dec;111(3):418-24. doi: 10.1016/j.ygyno.2008.08.021. Epub 2008 Oct 2. |
| 19157527 | Background | Magrina JF, Kho R, Montero RP, Magtibay PM, Pawlina W. Robotic extraperitoneal aortic lymphadenectomy: Development of a technique. Gynecol Oncol. 2009 Apr;113(1):32-5. doi: 10.1016/j.ygyno.2008.11.038. Epub 2009 Jan 21. |
| 20580322 | Background | Franco-Camps S, Cabrera S, Perez-Benavente A, Diaz-Feijoo B, Bradbury M, Xercavins J, Gil-Moreno A. Extraperitoneal laparoscopic approach for diagnosis and treatment of aortic lymph node recurrence in gynecologic malignancy. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):570-5. doi: 10.1016/j.jmig.2010.03.020. Epub 2010 Jun 30. |
| 27098143 | Derived | Diaz-Feijoo B, Correa-Paris A, Perez-Benavente A, Franco-Camps S, Sanchez-Iglesias JL, Cabrera S, de la Torre J, Centeno C, Puig OP, Gil-Ibanez B, Colas E, Magrina J, Gil-Moreno A. Prospective Randomized Trial Comparing Transperitoneal Versus Extraperitoneal Laparoscopic Aortic Lymphadenectomy for Surgical Staging of Endometrial and Ovarian Cancer: The STELLA Trial. Ann Surg Oncol. 2016 Sep;23(9):2966-74. doi: 10.1245/s10434-016-5229-9. Epub 2016 Apr 20. |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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