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

Symptomatic Gallbladder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932216
• Other study ID #: ISI-RCTSS-001
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: October 12, 2017
• Start date: September 2013
• Est. completion date: March 2017

Study information

• Verified date: October 2017
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gallbladder Diseases
• Symptomatic Gallbladder Disease

Intervention

Procedure:
• Cholecystectomy
Gallbladder removal

Locations

Country	Name	City	State
Greece	Athens Medical center	Marousi	Athens
United States	Dr. Omar Kudsi	Brockton	Massachusetts
United States	West Suburban Hospital	Elmwood Park	Illinois
United States	JFK Medical center	Lake Worth	Florida
United States	Baptist Health South Florida	Miami	Florida
United States	Huntington Memorial Hospital	Pasadena	California
United States	Drexel University	Philadelphia	Pennsylvania
United States	Hillcrest Medical Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Countries where clinical trial is conducted

United States,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 months after surgery