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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical
ClinicalTrials.gov Identifier:
NCT01932216
First received: August 27, 2013
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy

Condition Intervention
Symptomatic Gallbladder Disease
Procedure: Cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Intuitive Surgical:

Primary Outcome Measures:
  • Cosmesis [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 136
Study Start Date: September 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single-site robotic cholecystectomy
Single-site cholecystectomy using da Vinci robotic assisted surgery
Procedure: Cholecystectomy
Gallbladder removal
Active Comparator: Multi-port laparoscopic cholecystectomy
Multi-port cholecystectomy using laparoscopic surgery
Procedure: Cholecystectomy
Gallbladder removal

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932216

Locations
United States, California
Huntington Memorial Hospital
Pasadena, California, United States, 91105
United States, Florida
JFK Medical center
Lake Worth, Florida, United States, 33462
Baptist Health South Florida
Miami, Florida, United States, 33173
United States, Illinois
West Suburban Hospital
Elmwood Park, Illinois, United States, 60707
United States, Massachusetts
Dr. Omar Kudsi
Brockton, Massachusetts, United States, 02301
United States, Oklahoma
Hillcrest Medical Center
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Greece
Athens Medical center
Marousi, Athens, Greece, 15125
Sponsors and Collaborators
Intuitive Surgical
  More Information

Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT01932216     History of Changes
Other Study ID Numbers: ISI-RCTSS-001 
Study First Received: August 27, 2013
Last Updated: June 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Intuitive Surgical:
robotic single-site cholecystectomy
laparoscopic cholecystectomy
cosmesis
quality of life

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2016