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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Intuitive Surgical
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical
ClinicalTrials.gov Identifier:
NCT01932216
First received: August 27, 2013
Last updated: August 15, 2014
Last verified: August 2014
  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
Device: robotic single-site cholecystectomy
Device: Laparoscopic multiport cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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: 154
Study Start Date: September 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: robotic single-site cholecystectomy
patient in this arm will undergo robotic single-site cholecystectomy
Device: robotic single-site cholecystectomy
Other Name: da Vinci Single-Site™ Instrumentation for the da Vinci® Si™ System
Active Comparator: Laparoscopic multi-port cholecystectomy
Patient in this arm will undergo Laparoscopic multi-port cholecystectomy
Device: Laparoscopic multiport cholecystectomy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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 Recruiting
Pasadena, California, United States, 91105
Contact: Angelica Esparza    626-765-6405    angelica.ofc@gmail.com   
United States, Florida
JFK Medical center Recruiting
Lake Worth, Florida, United States, 33462
Contact: Victoria Vanacore    561-777-9120    vvanacore33@gmail.com   
Baptist Health South Florida Recruiting
Miami, Florida, United States, 33173
Contact: Edshelee Torrez    786-662-2315    EdsheleeT@baptisthealth.net   
Principal Investigator: Anthony Gonzalez, MD         
United States, Illinois
West Suburban Hospital Recruiting
Elmwood Park, Illinois, United States, 60707
Contact: Jennifer Duffy    708-453-6800    jen@newhopesurgical.com   
United States, Oklahoma
Hillcrest Medical Center Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Amy Garner    918-636-2417    Amy.Garner@hillcrest.com   
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Cynthia Gifford-Hollingsworth    267-507-6811    Cynthia.Gifford-Hollingsworth2@DrexelMed.edu   
Principal Investigator: Andrew Castellanos, MD         
Sponsors and Collaborators
Intuitive Surgical
  More Information

No publications provided

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: August 15, 2014
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 September 18, 2014