NCT06681831Completed
Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer
Feasibility, Safety, and Efficacy of Robotic Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer: A Pilot Study
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
Patients with clinically confirmed endometrioid endometrial cancer at FIGO stage IA-IB were eligible for robotic single-port hysterectomy (R-SPH). Criteria included: well or moderately differentiated tumor grade (G1 or G2), sufficient vaginal access, uterine size under 12 weeks' gestation, adequate bone marrow, kidney, liver, and heart function, and an ECOG performance status of 2 or below. Exclusions applied to patients with significant cardiopulmonary disease, previous pelvic or abdominal radiation, or severe hip disease affecting positioning. Prior abdominal surgeries did not exclude patients from robotic surgery. Surgeries were performed using the Vinci Single-Site® system by a specialized team. Clinical data collected included age, BMI, FIGO stage, tumor grade, surgical margin status, and hospital stay duration. Operation times were divided into docking, console (surgical), and total operation times. Intraoperative assessments included complications, blood loss, hemoglobin changes, and transfusions if hemoglobin was ≤7 g/L. Postoperative complications were evaluated short- and long-term, including surgical, cardiac, and respiratory events.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 4 Nov 2024
- Start date
- 26 Jun 2024
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Endometrial cancer, Childhood cancers
- NCT number
- NCT06681831
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 26 Jun 2024 to the primary completion date, 1 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \-
Who the study is looking for
- \-
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS regina elena cancer istitute Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.