Clinical trial NCT01932216: Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Official title: Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Gallbladder Disease
Keywords: robotic single-site cholecystectomy
laparoscopic cholecystectomy
cosmesis
quality of life
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2013-08-30
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Cosmesis
timeFrame: up to 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: Lake Worth
country: United States
facility: JFK Medical center
state: Florida
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Elmwood Park
country: United States
facility: West Suburban Hospital
state: Illinois
city: Brockton
country: United States
facility: Dr. Omar Kudsi
state: Massachusetts
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Marousi
country: Greece
facility: Athens Medical center
state: Athens
Study officials:
References:
citation: Kudsi OY, Castellanos A, Kaza S, McCarty J, Dickens E, Martin D, Tiesenga FM, Konstantinidis K, Hirides P, Mehendale S, Gonzalez A. Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial. Surg Endosc. 2017 Aug;31(8):3242-3250. doi: 10.1007/s00464-016-5353-4. Epub 2016 Nov 18.