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

Intuitive Surgical

Status: Completed

Conditions: Symptomatic Gallbladder Disease

Treatments: Procedure: Cholecystectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01932216

ISI-RCTSS-001

Details and patient eligibility

About

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

Full 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

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Single-site robotic cholecystectomy

Active Comparator group

Description:

Single-site cholecystectomy using da Vinci robotic assisted surgery

Treatment:

Procedure: Cholecystectomy

Multi-port laparoscopic cholecystectomy

Active Comparator group

Description:

Multi-port cholecystectomy using laparoscopic surgery

Treatment:

Procedure: Cholecystectomy