Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study

Not Applicable

• Conditions: Gynecological Surgery
• Interventions: Procedure: Surgical procedure with the system Kymerax; Device: The system Kymerax

• Registration Number: NCT01953627
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.

Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.

Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.

Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-24
• Study Start: 2012-10
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-24
• Primary Completion: 2014-09
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Patient requiring a following surgical procedure realized usually by coelioscopy:

Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis

Exclusion Criteria

• Patient refusing to participate in the study
• Patient understanding French.
• Minor waits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical procedure with the system Kymerax	The system Kymerax	-
Surgical procedure with the system Kymerax	Surgical procedure with the system Kymerax	-

Primary Outcome Measures

Name	Time	Method
assessment of Kymerax systemerax	18 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France