Uterine Diseases Clinical Trial
Official title:
Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study
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.
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