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

Primary Purpose

Symptomatic Gallbladder Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cholecystectomy
Sponsored by
Intuitive Surgical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Gallbladder Disease focused on measuring robotic single-site cholecystectomy, laparoscopic cholecystectomy, cosmesis, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huntington Memorial Hospital
  • JFK Medical center
  • Baptist Health South Florida
  • West Suburban Hospital
  • Dr. Omar Kudsi
  • Hillcrest Medical Center
  • Drexel University
  • Athens Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single-site robotic cholecystectomy

Multi-port laparoscopic cholecystectomy

Arm Description

Single-site cholecystectomy using da Vinci robotic assisted surgery

Multi-port cholecystectomy using laparoscopic surgery

Outcomes

Primary Outcome Measures

Cosmesis
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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2013
Last Updated
October 12, 2017
Sponsor
Intuitive Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT01932216
Brief Title
Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Official Title
Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Gallbladder Disease
Keywords
robotic single-site cholecystectomy, laparoscopic cholecystectomy, cosmesis, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-site robotic cholecystectomy
Arm Type
Active Comparator
Arm Description
Single-site cholecystectomy using da Vinci robotic assisted surgery
Arm Title
Multi-port laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
Multi-port cholecystectomy using laparoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
Cholecystectomy
Intervention Description
Gallbladder removal
Primary Outcome Measure Information:
Title
Cosmesis
Description
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.
Time Frame
up to 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
JFK Medical center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
West Suburban Hospital
City
Elmwood Park
State/Province
Illinois
ZIP/Postal Code
60707
Country
United States
Facility Name
Dr. Omar Kudsi
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Athens Medical center
City
Marousi
State/Province
Athens
ZIP/Postal Code
15125
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
27864724
Citation
Kudsi OY, Castellanos A, Kaza S, McCarty J, Dickens E, Martin D, Tiesenga FM, Konstantinidis K, Hirides P, Mehendale S, Gonzalez A. Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial. Surg Endosc. 2017 Aug;31(8):3242-3250. doi: 10.1007/s00464-016-5353-4. Epub 2016 Nov 18.
Results Reference
derived

Learn more about this trial

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

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