Symptomatic Gallbladder Disease Clinical Trial
Official title:
Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Verified date | October 2017 |
Source | Intuitive Surgical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy
Status | Completed |
Enrollment | 136 |
Est. completion date | March 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Athens Medical center | Marousi | Athens |
United States | Dr. Omar Kudsi | Brockton | Massachusetts |
United States | West Suburban Hospital | Elmwood Park | Illinois |
United States | JFK Medical center | Lake Worth | Florida |
United States | Baptist Health South Florida | Miami | Florida |
United States | Huntington Memorial Hospital | Pasadena | California |
United States | Drexel University | Philadelphia | Pennsylvania |
United States | Hillcrest Medical Center | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Intuitive Surgical |
United States, Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cosmesis | 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. | up to 3 months after surgery |