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Recent findings have suggested that laparoscopic surgery is safe and effective, as well as laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover, our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or lymphovascular space invasion.
Based on these considerations, the aim of the current protocol-study will be to compare two different strategies for vaginal cuff recurrences prevention in patients affected by ESEC treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation will be compared to post-operative brachytherapy.
Women with ESEC scheduled for laparoscopic surgery will be enrolled and randomized in three arms [vaginectomy group (VG), brachytherapy group (BG), and control group (CG)]. All laparoscopic procedures will consist of total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washing, systematic inspection of peritoneal cavity and biopsy of each suspect lesion, and pelvic (and eventual para-aortic) lymphadenectomy. In VG an upper vaginecomy will be added to standard laparoscopic procedures followed by observation, whereas BG will receive post-operative brachytherapy. CG will be treated with standard protocol for management of ESEC according to National Comprehensive Cancer Network (www.nccn.org).
Safety and efficacy data will be recorded in each group for 24 months of follow-up.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginectomy group | Experimental | Upper vaginectomy |
|
| Brachytherapy group | Experimental | Post-operative brachytherapy |
|
| Control group | Active Comparator | Standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper vaginectomy | Procedure | Laparoscopic surgery with upper vaginectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal cuff recurrences | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative complications | six months | |
| Adverse events | 24 months | |
| Loco-regional recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Palomba, MD | Contact | +39-0961.883234 | stefanopalomba@tin.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Palomba, MD | Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro | Principal Investigator |
| Fulvio Zullo, MD | Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Pugliese" Hospital | Recruiting | Catanzaro | 88100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16202724 | Background | Zullo F, Palomba S, Russo T, Falbo A, Costantino M, Tolino A, Zupi E, Tagliaferri P, Venuta S. A prospective randomized comparison between laparoscopic and laparotomic approaches in women with early stage endometrial cancer: a focus on the quality of life. Am J Obstet Gynecol. 2005 Oct;193(4):1344-52. doi: 10.1016/j.ajog.2005.02.131. |
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| Post-operative brachytherapy |
| Radiation |
Laparoscopic surgery followed by brachytherapy |
|
| Standard procedures | Procedure | Laparoscopic surgery +/- brachytherapy +/- pelvic radiation |
|
| 24 months |
| Distant recurrence rate | 24 months |
| Quality of life | 24 months |
| Overall survival | 24 months |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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