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

Completed · Not applicable

Conditions studied: Symptomatic Gallbladder Disease

In brief

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

Key facts

Study ID

NCT01932216

Run by

Intuitive Surgical

People needed

136

Starts

2013-09-01

Expected to finish

2017-03-01

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient between ages of 18- 80 year
• Patient with symptomatic gallbladder disease
• Patient willing to participate in this study and able to provide informed consent

You may not qualify if…

• Patient pregnancy
• Emergency patient
• Patient with acute cholecystitis
• Patient with upper midline visible abdominal scars or keloid
• Presence of umbilical hernia , or prior umbilical hernia repair
• Inability of patients to tolerate Trendelenberg position or pneumoperitoneum
• Patient with cirrhosis
• Patients with mental impairment that preclude giving informed consent

Where it is running

• Huntington Memorial Hospital — Pasadena, California, United States
• JFK Medical center — Lake Worth, Florida, United States
• Baptist Health South Florida — Miami, Florida, United States
• West Suburban Hospital — Elmwood Park, Illinois, United States
• Dr. Omar Kudsi — Brockton, Massachusetts, United States
• Hillcrest Medical Center — Tulsa, Oklahoma, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• Athens Medical center — Marousi, Athens, Greece

Full record on ClinicalTrials.gov

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