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| Name | Class |
|---|---|
| European Regional Development Fund | OTHER |
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The purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with 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 |
|---|---|---|---|
| Extraperitoneal | Experimental | Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy. |
|
| Transperitoneal | Active Comparator | Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications | Composite outcome defined by including at least one of the following:
| intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery |
| 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. | Postoperatively (within 1 week), at the moment of histopathologic examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Gil Moreno, MD, PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Study Chair |
| Berta Diaz Feijoo, MD, PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Study Director |
| Alejandro Correa Paris, MD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| M. Assumpció Pérez-Benavente, MD, PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| Silvia Franco Camps, MD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| Jose Luis Sánchez Iglesias, MD, PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| Silvia Cabrera DÃaz, MD, PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| Oriol Puig Puig, MD | 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 | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8641608 | Background | Vasilev SA, McGonigle KF. Extraperitoneal laparoscopic para-aortic lymph node dissection. Gynecol Oncol. 1996 Jun;61(3):315-20. doi: 10.1006/gyno.1996.0149. | |
| 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. |
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|
| 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. |
|
|
| 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 |
| Hospital stay | The number of days that patients stay in the hospital after surgery, measured in days from the day of the surgery to the day the patient is discharged from the hospital. | Measured the day the patient is discharged (up to 100 days) |
| Overall survival | Number of patients alive after surgery. | up to 3 years after surgery |
| Disease-free survival | Period of time in which there is no appearance of the symptoms or effects of the disease. | up to 3 years after surgery |
| Javier De La Torre, MD, PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Principal Investigator |
| 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. |
| 18538379 | Background | 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. |
| 18607826 | Background | Gil-Moreno A, Franco-Camps S, Diaz-Feijoo B, Perez-Benavente A, Martinez-Palones JM, Del Campo JM, Parera M, Verges R, Castellvi J, Xercavins J. Usefulness of extraperitoneal laparoscopic paraaortic lymphadenectomy for lymph node recurrence in gynecologic malignancy. Acta Obstet Gynecol Scand. 2008;87(7):723-30. doi: 10.1080/00016340802136343. |
| 24361579 | Background | Pakish J, Soliman PT, Frumovitz M, Westin SN, Schmeler KM, Reis RD, Munsell MF, Ramirez PT. A comparison of extraperitoneal versus transperitoneal laparoscopic or robotic para-aortic lymphadenectomy for staging of endometrial carcinoma. Gynecol Oncol. 2014 Feb;132(2):366-71. doi: 10.1016/j.ygyno.2013.12.019. Epub 2013 Dec 20. |
| 20188409 | Background | Dowdy SC, Mariani A. Lymphadenectomy in endometrial cancer: when, not if. Lancet. 2010 Apr 3;375(9721):1138-40. doi: 10.1016/S0140-6736(09)62068-7. Epub 2010 Feb 24. No abstract available. |
| 18304622 | Background | Mariani A, Dowdy SC, Cliby WA, Gostout BS, Jones MB, Wilson TO, Podratz KC. Prospective assessment of lymphatic dissemination in endometrial cancer: a paradigm shift in surgical staging. Gynecol Oncol. 2008 Apr;109(1):11-8. doi: 10.1016/j.ygyno.2008.01.023. Epub 2008 Mar 4. |
| 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. |
| 24231134 | Background | Diaz-Feijoo B, Gil-Ibanez B, Perez-Benavente A, Martinez-Gomez X, Colas E, Sanchez-Iglesias JL, Cabrera-Diaz S, Puig-Puig O, Magrina JF, Gil-Moreno A. Comparison of robotic-assisted vs conventional laparoscopy for extraperitoneal paraaortic lymphadenectomy. Gynecol Oncol. 2014 Jan;132(1):98-101. doi: 10.1016/j.ygyno.2013.11.004. Epub 2013 Nov 11. |
| 34022445 | Derived | Bebia V, Gil-Moreno A, Hernandez A, Gilabert-Estelles J, Franco-Camps S, de la Torre J, Siegrist J, Chipirliu A, Cabrera S, Bradbury M, Perez-Benavente A, Diaz-Feijoo B. Robot-assisted Extraperitoneal Para-aortic Lymphadenectomy Is Associated with Fewer Surgical Complications: A Post Hoc Analysis of the STELLA-2 Randomized Trial. J Minim Invasive Gynecol. 2021 Dec;28(12):2004-2012.e1. doi: 10.1016/j.jmig.2021.05.009. Epub 2021 May 20. |
| 33160695 | Derived | Diaz-Feijoo B, Bebia V, Hernandez A, Gilabert-Estalles J, Franco-Camps S, de la Torre J, Segrist J, Chipirliu A, Cabrera S, Perez-Benavente A, Gil-Moreno A. Surgical complications comparing extraperitoneal vs transperitoneal laparoscopic aortic staging in early stage ovarian and endometrial cancer. Gynecol Oncol. 2021 Jan;160(1):83-90. doi: 10.1016/j.ygyno.2020.10.038. Epub 2020 Nov 5. |
| 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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