Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Intuitive Surgical
- Enrollment
- 136
- Locations
- 8
- Primary Endpoint
- Cosmesis
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single-site robotic cholecystectomy
Single-site cholecystectomy using da Vinci robotic assisted surgery
Intervention: Cholecystectomy (Procedure)
Multi-port laparoscopic cholecystectomy
Multi-port cholecystectomy using laparoscopic surgery
Intervention: Cholecystectomy (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported