Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

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.

Patient Inclusion Criteria:

• Age ≥ 18 years old
• Sign the informed consent form
• BMI ≤ 40
• A.S.A. Class < III or IV

Disease Inclusion Criteria:

• Ovarian cyst (enucleation/oophorectomy)
• Prophylactic bilateral oophorectomy
• Ectopic pregnancy (salpingotomy/salpingectomy)
• Tubal inflammatory disease (salpingotomy/salpingectomy)
• Infertility and sterility (treatment of endometriosis, chromo-salpingography, etc.)
• Benign uterine disease (Fibromatosis, Adenomyosis)
• Endometrial hyperplasia
• Stage Ia G1-2 Endometrial tumors
• Precancerous lesions of the uterine cervix
• Stage Ia uterine cervical tumors
• Pelvic endometriosis

Patient Exclusion Criteria:

• Pregnancy
• Liver disease
• Coagulation disorders
• Patient internal or anatomical criteria that preclude a laparoscopic approach