Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer

NCT06681831CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

15

Start Date

2024-06-26

Completion Date

2024-10-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

DaVinci SP

Conditions

Endometrial Cancer

Eligibility

Sex

FEMALE

Inclusion Criteria: Patients with clinically confirmed endometrioid endometrial cancer, FIGO stage IA-IB.

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Exclusion Criteria: significant cardiopulmonary disease or contraindications for prolonged Trendelenburg position; prior pelvic or abdominal radiotherapy; severe hip disease limiting dorsolithotomy position

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Outcome Measures

Primary Outcomes

Operative Time

duration of the hysterectomy, measured in minutes

Time frame: during the intervention/procedure/surgery

Docking Time

Duration of the davinci SP docking, measured in minutes

Time frame: during the intervention/procedure/surgery

Console Time

Time spent by the surgeon in the console during the surgical operation, measured in minutes

Time frame: during the intervention/procedure/surgery

Blood loss

Blood loss during the surgery, measured in ml

Time frame: during the intervention/procedure/surgery

Change in hemoglobin

Change in hemoglobin after the surgery, measured in g/dl

Time frame: immediately after the intervention/procedure/surgery

Locations

IRCCS regina elena cancer istitute, Rome, Italy

Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer