Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

SOFAR

Status: Completed

Conditions: Adnexal Diseases; Uterine Diseases

Treatments: Device: TELELAP ALF-X Robotic Surgical System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03093675

TELELAP-ALF-X

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

TELELAP ALF-X Robotic Surgical System

Experimental group

Description:

The patients will undergo surgical procedures using the innovative TELELAP ALF-X robotic system.

Treatment:

Device: TELELAP ALF-X Robotic Surgical System