CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
3D Laparoscopic visual system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01930344
NCT01930344N/ACompleted

Does Three-Dimensional Laparoscopy Provide Significant Advantages for Patients and Surgeons? A Randomised Controlled Trial Investigating Operating Time and Surgical Errors With 3D vs 2D Visual Systems in Laparoscopic Cholecystectomies.

Royal Surrey County Hospital NHS Foundation Trust·interventional·Posted Aug 28, 2013·Updated Dec 3, 2015

In Brief

A clinical study evaluating 3D Laparoscopic visual system and 2D Laparoscopic visual system for Gall Bladder Disease. Completed, enrolled 114 participants across 1 site.

Detailed Summary

During laparoscopic surgery, your surgeon operates through 'keyhole' incisions in your abdomen. These allow long tools and a camera to pass to perform the surgery and allow the surgeon to see inside you. The cameras images are seen on a television screen, and this is viewed, like you watch television at home, in a two-dimensional (2D), form. This can make performing laparoscopic surgery very challenging, as you have to learn to appreciate depth while performing surgical tasks. Recent advances in viewing technology mean we now have the capability for comfortable three-dimensional (3D) viewing of laparoscopic surgery, and many centers have shown its superiority over 2D in lab-based experiments. However, this technology has never been compared against our normal gold standard 2D imaging in laparoscopic operations. This study aims to investigate whether there is a quantifiable benefit in using these new 3D imaging systems over 2D for laparoscopy, as we hypothesise that there is a marked benefit using 3D over 2D. Patients who have been placed on the waiting list for keyhole surgery to remove their gallbladder will be invited to take part in the study. If they agree, they will undergo the standard operation for removing their gallbladder as planned already. At the beginning of the operation they will be randomised (selected by chance) into one of two groups. One group will have their surgery performed to our current 'Gold standard' with the surgeon using a 2D camera and screen. The other group will have the exact same operation but with the surgeon using a 3D camera and screen. The intra-abdominal part of the operation will be recorded and viewed by an independent observer who is a surgeon, to assess for technical performance differences between operations performed in 2D and 3D, as well as time taken for the surgery. There are no extra risks to taking part and being randomised to the 3D group. The laparoscopic camera is the same size as a 2D camera and used in the same way. There are no real disadvantages, as patients will still undergo the operation they were booked for and will experience no change in their treatment. The aim is to compare 2D and 3D Day Case Laparoscopic Cholecystectomies, to see if there is a marked difference with this new technology. Lab based studies imply that 3D imaging systems reduce surgical errors and operating time therefore could improve patient safety. This study may help improve laparoscopic surgery for future patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 28, 2013
Enrollment StartMay 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.8 years ago

Interventions

3D Laparoscopic visual systemdevice

Three-dimensional endoscope used for surgery - multiple company products - and passive polarising three-dimensional laparoscopic displays;

2D Laparoscopic visual systemdevice

Standard 2D HD Laparoscopic Visual System