Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

March 27, 2017 updated by: SOFAR S.p.A.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TELELAP ALF-X Robotic Surgical System
The patients will undergo surgical procedures using the innovative TELELAP ALF-X robotic system.
Device: TELELAP ALF-X Robotic Surgical System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and complications of robotic assisted surgery in the treatment of gynecological diseases
Time Frame: 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.
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
Time Frame: Through study completion, on average 1 year
Assessment of the Robotic assisted surgery learning curve through an assessment of procedure times
Through study completion, on average 1 year
Procedure times
Time Frame: Day of surgical intervention
The duration of each procedure will be registered. Mean duration will be estimated
Day of surgical intervention
Intra- and post-operative complications
Time Frame: 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
Day of surgical intervention, 24h post-surgery and after 30-day follow-up
Post-operative pain
Time Frame: 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)
End of surgery to 24 hours post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOFAR S.p.A.

Investigators

  • Principal Investigator: Giovanni Scambia, Professor, Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 23, 2013

Primary Completion (ACTUAL)

December 9, 2014

Study Completion (ACTUAL)

December 9, 2014

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

March 27, 2017

First Posted (ACTUAL)

March 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TELELAP-ALF-X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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