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

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Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci
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

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
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1 Pearl Street
Brockton, Massachusetts 02301
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Brockton, MA
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Elmwood Park, Illinois 60707
Phone: 708-453-6800
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Elmwood Park, IL
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Lake Worth, Florida 33462
Phone: 561-777-9120
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Lake Worth, FL
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5 Distomou
Marousi, Athens 15125
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Marousi,
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Pasadena, California 91105
Phone: 626-765-6405
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Pasadena, CA
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Principal Investigator: Andrew Castellanos, MD
Phone: 267-507-6811
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Philadelphia, PA
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Tulsa, Oklahoma 74101
Phone: 918-636-2417
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Tulsa, OK
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