Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

Conditions
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Adnexal Diseases, Uterine Diseases

Intervention / Treatment
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* Device: TELELAP ALF-X Robotic Surgical System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TELELAP ALF-X Robotic Surgical System<br>The patients will undergo surgical procedures using the innovative TELELAP ALF-X robotic system. | Device: TELELAP ALF-X Robotic Surgical System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-operative to 30 days follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, on average 1 year | 
| Procedure times | The duration of each procedure will be registered. Mean duration will be estimated | Day of surgical intervention | 
| Intra- and post-operative complications | The number of intra- and post-operative complications complications will be registered and described | 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) | End of surgery to 24 hours post-op |