Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 10/18/2017 |
Start Date: | September 2013 |
End Date: | March 2017 |
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci
Single Site Instruments™ to multi-port (four ports) laparoscopy
Single Site Instruments™ to multi-port (four ports) laparoscopy
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
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
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
We found this trial at
8
sites
Miami, Florida 33183
Principal Investigator: Anthony Gonzalez, MD
Phone: 786-662-2315
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Philadelphia, Pennsylvania 19102
Principal Investigator: Andrew Castellanos, MD
Phone: 267-507-6811
Click here to add this to my saved trials
Click here to add this to my saved trials