Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

Uterine Diseases Clinical Trial

Official title:

Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093675
• Other study ID #: TELELAP-ALF-X
• Status: Completed
• Phase: N/A
• First received: March 16, 2017
• Last updated: March 27, 2017
• Start date: October 23, 2013
• Est. completion date: December 9, 2014

Study information

• Verified date: March 2017
• Source: SOFAR S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the feasibility, efficacy and safety of this approach.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 9, 2014
• Est. primary completion date: December 9, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adnexal Diseases
• Genital Diseases, Female
• Uterine Diseases

Intervention

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.

Locations

Country	Name	City	State
Italy	Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
SOFAR S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (12)

Advincula AP, Song A. The role of robotic surgery in gynecology. Curr Opin Obstet Gynecol. 2007 Aug;19(4):331-6. Review. — View Citation

Carvalho L, Abrão 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. Review. — View Citation

De Ugarte DA, Etzioni DA, Gracia C, Atkinson JB. Robotic surgery and resident training. Surg Endosc. 2003 Jun;17(6):960-3. Epub 2003 Mar 28. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Marchal F, Rauch P, Verhaeghe JL, Guillemin F. [Laparoscopic surgery and robot]. Bull Cancer. 2007 Dec;94(12):1075-80. Review. French. — View Citation

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. — View Citation

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

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

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. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Through study completion, on average 1 year
Secondary	Procedure times	The duration of each procedure will be registered. Mean duration will be estimated	Day of surgical intervention
Secondary	Intra- and post-operative complications	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
Secondary	Post-operative pain	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