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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Intuitive Surgical
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical
ClinicalTrials.gov Identifier:
NCT01932216
First received: August 27, 2013
Last updated: August 29, 2013
Last verified: August 2013
  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: March 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.

No Contacts or Locations Provided
  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 29, 2013
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 20, 2014