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Adnexal DiseasesNCT03093675

Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

A study testing TELELAP ALF-X Robotic Surgical System in people with Adnexal Diseases and Uterine Diseases, run by SOFAR S.p.A. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Adnexal Diseases, Uterine Diseases
What is being tested?
TELELAP ALF-X Robotic Surgical System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteItaly
Study dates
23 Oct 2013to 9 Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

Italy1 site

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

    Rome, 00168

Other trials in Italy

About this study

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.

Read the 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.

Being tested
TELELAP ALF-X Robotic Surgical System
Medical subject headings
Adnexal Diseases, Uterine Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TELELAP ALF-X Robotic Surgical SystemDevice

    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.

Study groups in NCT03093675
Study groupRoleWhat they receive
TELELAP ALF-X Robotic Surgical SystemExperimentalThe patients will undergo surgical procedures using the innovative TELELAP ALF-X robotic system.
Receives: Device: TELELAP ALF-X Robotic Surgical System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre-operative to 30 days follow-up

Secondary outcomes (4)

  1. 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

    Measured: Through study completion, on average 1 year

  2. Procedure times

    The duration of each procedure will be registered. Mean duration will be estimated

    Measured: Day of surgical intervention

  3. Intra- and post-operative complications

    The number of intra- and post-operative complications complications will be registered and described

    Measured: Day of surgical intervention, 24h post-surgery and after 30-day follow-up

  4. Post-operative pain

    Post-operative pain will be reported by the patients through a 10-points VAS scale (1-10)

    Measured: End of surgery to 24 hours post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start23 Oct 2013
  3. Primary completion9 Dec 2014
  4. Study completion9 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03093675
Sponsor's protocol ID
TELELAP-ALF-X
Status last verified
Mar 2017
First submitted
16 Mar 2017
Last updated
28 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schreuder HW, Verheijen RH. Robotic surgery. BJOG. 2009 Jan;116(2):198-213. doi: 10.1111/j.1471-0528.2008.02038.x.

    PubMed 19076952

  • Murphy DG, Hall R, Tong R, Goel R, Costello AJ. Robotic technology in surgery: current status in 2008. ANZ J Surg. 2008 Dec;78(12):1076-81. doi: 10.1111/j.1445-2197.2008.04754.x.

    PubMed 19087046

  • Heemskerk J, van Gemert WG, de Vries J, Greve J, Bouvy ND. Learning curves of robot-assisted laparoscopic surgery compared with conventional laparoscopic surgery: an experimental study evaluating skill acquisition of robot-assisted laparoscopic tasks compared with conventional laparoscopic tasks in inexperienced users. Surg Laparosc Endosc Percutan Tech. 2007 Jun;17(3):171-4. doi: 10.1097/SLE.0b013e31805b8346.

    PubMed 17581459

  • Nezhat C, Saberi NS, Shahmohamady B, Nezhat F. Robotic-assisted laparoscopy in gynecological surgery. JSLS. 2006 Jul-Sep;10(3):317-20.

    PubMed 17212887

  • Advincula AP, Song A. The role of robotic surgery in gynecology. Curr Opin Obstet Gynecol. 2007 Aug;19(4):331-6. doi: 10.1097/GCO.0b013e328216f90b.

    PubMed 17625414

  • Marchal F, Rauch P, Verhaeghe JL, Guillemin F. [Laparoscopic surgery and robot]. Bull Cancer. 2007 Dec;94(12):1075-80. doi: 10.1684/bdc.2007.0524. French.

    PubMed 18156116

  • De Ugarte DA, Etzioni DA, Gracia C, Atkinson JB. Robotic surgery and resident training. Surg Endosc. 2003 Jun;17(6):960-3. doi: 10.1007/s00464-002-8745-6. Epub 2003 Mar 28.

    PubMed 12658424

  • Weinberg L, Rao S, Escobar PF. Robotic surgery in gynecology: an updated systematic review. Obstet Gynecol Int. 2011;2011:852061. doi: 10.1155/2011/852061. Epub 2011 Nov 28.

    PubMed 22190948

  • Ercoli A, D'asta M, Fagotti A, Fanfani F, Romano F, Baldazzi G, Salerno MG, Scambia G. Robotic treatment of colorectal endometriosis: technique, feasibility and short-term results. Hum Reprod. 2012 Mar;27(3):722-6. doi: 10.1093/humrep/der444. Epub 2012 Jan 11.

    PubMed 22238113

  • Carvalho L, Abrao MS, Deshpande A, Falcone T. Robotics as a new surgical minimally invasive approach to treatment of endometriosis: a systematic review. Int J Med Robot. 2012 Jun;8(2):160-5. doi: 10.1002/rcs.451. Epub 2011 Dec 9.

    PubMed 22162096

  • Yim GW, Kim YT. Robotic surgery in gynecologic cancer. Curr Opin Obstet Gynecol. 2012 Feb;24(1):14-23. doi: 10.1097/GCO.0b013e32834daebc.

    PubMed 22123220

  • Fagotti A, Gagliardi ML, Fanfani F, Salerno MG, Ercoli A, D'Asta M, Tortorella L, Turco LC, Escobar P, Scambia G. Perioperative outcomes of total laparoendoscopic single-site hysterectomy versus total robotic hysterectomy in endometrial cancer patients: a multicentre study. Gynecol Oncol. 2012 Jun;125(3):552-5. doi: 10.1016/j.ygyno.2012.02.035. Epub 2012 Mar 3.

    PubMed 22391483

Questions about this trial

What is this clinical trial studying?

A study testing TELELAP ALF-X Robotic Surgical System in people with Adnexal Diseases and Uterine Diseases, run by SOFAR S.p.A. at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and complications of robotic assisted surgery in the treatment of gynecological diseases (time frame: Pre-operative to 30 days follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03093675, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.

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