NCT01932216

Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy

Detailed description

Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy. * The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach. * The secondary objective of this study is to assess the peri-operative clinical outcomes of robotic- assisted single incision cholecystectomy with da Vinci Single - Site Instruments™ in comparison to a multiport laparoscopic approach. * The third objective of this study is to evaluate hernia incidence at 1 year and 18 months after surgery

Conditions

• Symptomatic Gallbladder Disease

Interventions

Type	Name	Description
PROCEDURE	Cholecystectomy	Gallbladder removal

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2013-08-30
• Last updated: 2017-10-16

Locations

8 sites across 2 countries: United States, Greece