Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

NCT03093675 | Completed

• 1 other identifier: TELELAP-ALF-X
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Adnexal Diseases; Uterine Diseases

Outcome Measures

Primary Outcomes (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.

  Pre-operative to 30 days follow-up

Secondary Outcomes (4)

• Robotic assisted surgery learning curve assessed through the reduction of procedure times

  Through study completion, on average 1 year

• Procedure times

  Day of surgical intervention

• Intra- and post-operative complications

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

• Post-operative pain

  End of surgery to 24 hours post-op

Study Arms (1)

TELELAP ALF-X Robotic Surgical System

EXPERIMENTAL

The patients will undergo surgical procedures using the innovative TELELAP ALF-X robotic system.

Device: TELELAP ALF-X Robotic Surgical System

Interventions

TELELAP ALF-X Robotic Surgical System DEVICE

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.

TELELAP ALF-X Robotic Surgical System

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study concerns female-only diseases, adnexal and uterine diseases
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Sign the informed consent form
• BMI ≤ 40
• A.S.A. Class \< III or IV
• 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

You may not qualify if:

• Pregnancy
• Liver disease
• Coagulation disorders
• Patient internal or anatomical criteria that preclude a laparoscopic approach

Sponsors & Collaborators

• SOFAR S.p.A.: lead

Study Sites (1)

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

Rome, 00168, Italy

Location

Related Publications (12)

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

  PMID: 19076952 BACKGROUND

• 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.

  PMID: 19087046 BACKGROUND

• 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.

  PMID: 17581459 BACKGROUND

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

  PMID: 17212887 BACKGROUND

• 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.

  PMID: 17625414 BACKGROUND

• 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.

  PMID: 18156116 BACKGROUND

• 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.

  PMID: 12658424 BACKGROUND

• 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.

  PMID: 22190948 BACKGROUND

• 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.

  PMID: 22238113 BACKGROUND

• 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.

  PMID: 22162096 BACKGROUND

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

  PMID: 22123220 BACKGROUND

• 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.

  PMID: 22391483 BACKGROUND

MeSH Terms

Conditions

Adnexal Diseases; Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 28, 2017
• Study Start: October 23, 2013
• Primary Completion: December 9, 2014
• Study Completion: December 9, 2014
• Last Updated: March 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)