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

October 12, 2017 updated by: Intuitive Surgical
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmesis
Time Frame: 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.
up to 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (ESTIMATE)

August 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI-RCTSS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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