Clinical trial · Interventional
Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery
Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Endometrial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-operative brachytherapy | Radiation | — | UNRESOLVED |
| Standard procedures | Procedure | — | UNRESOLVED |
| Upper vaginectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vaginectomy group
- description
- Upper vaginectomy
- interventionNames
- Procedure: Upper vaginectomy
- type
- EXPERIMENTAL
- label
- Brachytherapy group
- description
- Post-operative brachytherapy
- interventionNames
- Radiation: Post-operative brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Standard treatment
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Early stage endometrial cancer Exclusion Criteria: * Other pre-malignancies and malignancies * Major medical conditions * Psychiatric disorders * Current or past history of acute or chronic physical illness * Premenstrual syndrome (PMS) * Current or past (within 6 months from study enrolment) use of drugs influencing cognition, vigilance, and/or mood.
References
Publications (1)
- BACKGROUNDZullo 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. PMID 16202724