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

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

Detailed Description
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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

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

Conditions
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Symptomatic Gallbladder Disease

Intervention / Treatment
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* Procedure: Cholecystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single-site robotic cholecystectomy<br>Single-site cholecystectomy using da Vinci robotic assisted surgery | Procedure: Cholecystectomy<br>* Gallbladder removal<br>|
| Active Comparator: Multi-port laparoscopic cholecystectomy<br>Multi-port cholecystectomy using laparoscopic surgery | Procedure: Cholecystectomy<br>* Gallbladder removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic single-site cholecystectomy, laparoscopic cholecystectomy, cosmesis, quality of life