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OpenTrials
Completed

NCT Number: NCT01932216

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athens Medical center, Marousi, Athens, Greece

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy

Procedure

Gallbladder removal

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Aug 30, 2013
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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