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

Not Applicable

Completed

• Conditions: Symptomatic Gallbladder Disease

• Registration Number: NCT01932216
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Study Start: 2013-09
• Primary Completion: 2016-12
• Study Completion: 2017-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cosmesis	up to 3 months after surgery	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.

Trial Locations

Locations (8)

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