This is a prospective, single-center clinical trial. One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach.
The study proposed comprises a prospective, single-center clinical trial (Catholic University of the Sacred Heart of Rome, A. Gemelli University Polyclinic). One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach. Post-operative pain will be reported by the patients through a Visual Analog Scale (VAS). It will be assessed at 2, 4 and 12 and 24 hours after the procedure. At the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the standard laparoscopic approach to multiple access and/or to a laparotomic approach will be analyzed in order to arrive at the feasibility and efficacy of robotic assisted treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The surgical procedures will be performed using the innovative TELELAP ALF-X robotic system, equipped with multiple independent arms. Initial entry will be through a classic open in which the arm with the video camera will be inserted. The device has four independent arms (one for the video camera and three for surgical instruments). Patients will be in the lithotomy position, supported by Allen stirrups and under general anesthesia. The uterus will be manipulated with a multi-use uterine manipulator. After having induced a pneumoperitoneum, high-definition 3D-technology optics will be inserted. Three laparoscopic instruments will be used to complete the procedure. Standard techniques will be used.
Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart
Rome, Italy
Feasibility and complications of robotic assisted surgery in the treatment of gynecological diseases
The rate of complications and conversions to laparoscopic/laparotomic surgery will be collected and calculated. As this is a pilot study, no pre-determined success criteria has been set. The number of complications observed during robotic assisted surgery in the treatment of gynecological diseases will be registered.
Time frame: Pre-operative to 30 days follow-up
Robotic assisted surgery learning curve assessed through the reduction of procedure times
Assessment of the Robotic assisted surgery learning curve through an assessment of procedure times
Time frame: Through study completion, on average 1 year
Procedure times
The duration of each procedure will be registered. Mean duration will be estimated
Time frame: Day of surgical intervention
Intra- and post-operative complications
The number of intra- and post-operative complications complications will be registered and described
Time frame: Day of surgical intervention, 24h post-surgery and after 30-day follow-up
Post-operative pain
Post-operative pain will be reported by the patients through a 10-points VAS scale (1-10)
Time frame: End of surgery to 24 hours post-op
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