CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
DaVinci SPdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06681831
NCT06681831N/ACompleted

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·interventional·Posted Nov 8, 2024·Updated Nov 8, 2024

In Brief

A clinical study evaluating DaVinci SP for Endometrial Cancer. Completed, enrolled 15 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedNov 8, 2024
Enrollment StartJun 26, 2024
Primary CompletionOct 1, 2024
Study CompletionOct 15, 2024
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 1.7 years ago

Interventions

DaVinci SPdevice

robotic single-port hysterectomy (R-SPH) with DaVinci SP