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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01932216

Enrollment

136

Registered

2013-08-30

Start date

2013-09-30

Completion date

2017-03-31

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Gallbladder Disease

Keywords

robotic single-site cholecystectomy, laparoscopic cholecystectomy, cosmesis, quality of life

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

Interventions

PROCEDURECholecystectomy

Gallbladder removal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Cosmesis	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.

Countries

Greece, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026