Clinical trial NCT03093675: Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study
Official title: Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adnexal Diseases
Uterine Diseases
Lead sponsor: SOFAR S.p.A.
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasibility and complications of robotic assisted surgery in the treatment of gynecological diseases
timeFrame: Pre-operative to 30 days follow-up
Secondary outcomes:
measure: Robotic assisted surgery learning curve assessed through the reduction of procedure times
timeFrame: Through study completion, on average 1 year
measure: Procedure times
timeFrame: Day of surgical intervention
measure: Intra- and post-operative complications
timeFrame: Day of surgical intervention, 24h post-surgery and after 30-day follow-up
measure: Post-operative pain
timeFrame: End of surgery to 24 hours post-op
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart
Study officials:
affiliation: Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart
name: Giovanni Scambia, Professor
role: PRINCIPAL_INVESTIGATOR
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