Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
NCT ID: NCT01932216
Last Updated: 2017-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2013-09-30
2017-03-31
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-site robotic cholecystectomy
Single-site cholecystectomy using da Vinci robotic assisted surgery
Cholecystectomy
Gallbladder removal
Multi-port laparoscopic cholecystectomy
Multi-port cholecystectomy using laparoscopic surgery
Cholecystectomy
Gallbladder removal
Interventions
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Cholecystectomy
Gallbladder removal
Eligibility Criteria
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Inclusion Criteria
* Patient with symptomatic gallbladder disease
* Patient willing to participate in this study and able to provide informed consent
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Intuitive Surgical
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Kudsi OY, Castellanos A, Kaza S, McCarty J, Dickens E, Martin D, Tiesenga FM, Konstantinidis K, Hirides P, Mehendale S, Gonzalez A. Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial. Surg Endosc. 2017 Aug;31(8):3242-3250. doi: 10.1007/s00464-016-5353-4. Epub 2016 Nov 18.
Other Identifiers
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ISI-RCTSS-001
Identifier Type: -
Identifier Source: org_study_id