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

N/ACompletedNCT01932216

Intuitive Surgical136 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Symptomatic Gallbladder Disease

Interventions

CholecystectomyPROCEDURE

Gallbladder removal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (8)

Huntington Memorial Hospital

Pasadena, California, United States

JFK Medical center

Lake Worth, Florida, United States

Baptist Health South Florida

Miami, Florida, United States

West Suburban Hospital

Elmwood Park, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 3 months after surgery

Data from ClinicalTrials.gov

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