Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX

Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis Clinical Trial

— OB-ALFX  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02338505
• Other study ID #: 21264/14
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 12, 2015
• Last updated: January 13, 2015
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2015
• Source: Catholic University of the Sacred Heart
• Contact: Salvatore Gueli Alletti, MD
• Email: gueliallettis[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Phase II prospective single-institutional study.

Description:

The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• informed consent

• 30 = BMI < 40

• ASA < III

• Ovarian Cyst

• Prophylactic bilateral salpingo-oophorectomy

• Ectopic Pregnancy

• Pelvic Inflammatory Disease

• Sterility/Infertility

• Benign uterine disease (fibromatosis, adenomyosis)

• Endometrial hiperplasia

• Early-stage Endometrial Cancer

• Preneoplastic lesions of the cervix

• IA1 Cervical Cancer

• Pelvic endometriosis

Exclusion Criteria:

• Pregnancy

• Liver disease

• Coagulopathies

• Clinical conditions contraindicating laparoscopy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis
• Genital Diseases, Female

Intervention

Device:
• Telelap ALF-X
Patients placed in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. After achieving pneumoperitoneum (12mmHg) through a trans umbilical open access technique, intra-abdominal visualization was obtained with a 10mm 0° HD 3D telescope. During the trocar placement the operative room nurses supported the surgeon in the docking procedures approaching the robotic arms to the operative table, in places established for pelvic surgery. The cockpit is located in one corner of our square shape room; the operative table is surrounded by the three robotic arms unit. Through the teleassisted operative ports we could make use of several type of instruments. Movements of both instruments and optic were completely carried out by the surgeon from the cockpit according to the needs of the procedure.

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart Rome,	Rome,	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	SOFAR S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Falavolti C, Gidaro S, Ruiz E, Altobelli E, Stark M, Ravasio G, Ravasio G, Lazzaretti SS, Buscarini M. Experimental Nephrectomies Using a Novel Telesurgical System: (The Telelap ALF-X)-A Pilot Study. Surg Technol Int. 2014 Nov;25:37-41. — View Citation

Gidaro S, Altobelli E, Falavolti C, Bove AM, Ruiz EM, Stark M, Ravasio G, Lazzaretti SS, Maurizio B. Vesicourethral anastomosis using a novel telesurgical system with haptic sensation, the Telelap Alf-X: a pilot study. Surg Technol Int. 2014 Mar;24:35-40. — View Citation

Gidaro S, Buscarini M, Ruiz E, Stark M, Labruzzo A. Telelap Alf-X: a novel telesurgical system for the 21st century. Surg Technol Int. 2012 Dec;22:20-5. — View Citation

Lococo A, Larocca V, Marino F, De Filippis AF, Cesario A, Lococo F. Experimental Robotic Pulmonary Lobectomy With the TELELAP/ALFX System in the Ovine Model. Surg Innov. 2015 Jun;22(3):252-6. doi: 10.1177/1553350614549633. Epub 2014 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative complication rate	Operative time, conversion rate, estimated blood loss, visceral injury	intraoperative	Yes
Secondary	postoperative complication rate	Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death	30 days	Yes

External Links

•   Link