Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study
- Conditions
- Adnexal DiseasesUterine Diseases
- Interventions
- Device: TELELAP ALF-X Robotic Surgical System
- Registration Number
- NCT03093675
- Lead Sponsor
- SOFAR S.p.A.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- 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
- Pregnancy
- Liver disease
- Coagulation disorders
- Patient internal or anatomical criteria that preclude a laparoscopic approach
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TELELAP ALF-X Robotic Surgical System TELELAP ALF-X Robotic Surgical System The patients will undergo surgical procedures using the innovative TELELAP ALF-X robotic system.
- Primary Outcome Measures
Name Time Method Feasibility and complications of robotic assisted surgery in the treatment of gynecological diseases Pre-operative to 30 days follow-up 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.
- Secondary Outcome Measures
Name Time Method Robotic assisted surgery learning curve assessed through the reduction of procedure times Through study completion, on average 1 year Assessment of the Robotic assisted surgery learning curve through an assessment of procedure times
Post-operative pain End of surgery to 24 hours post-op Post-operative pain will be reported by the patients through a 10-points VAS scale (1-10)
Procedure times Day of surgical intervention The duration of each procedure will be registered. Mean duration will be estimated
Intra- and post-operative complications Day of surgical intervention, 24h post-surgery and after 30-day follow-up The number of intra- and post-operative complications complications will be registered and described
Trial Locations
- Locations (1)
Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart
🇮🇹Rome, Italy