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NCT03143426

Does 3D Visualisation Improve Performance of Laparoscopic Cholecystectomy by Junior Surgeons?

Completed NA Last updated 26 January 2018
What this trial tests

NA trial testing 3D laparoscopic cholecystectomy in Complication Laparoscopic Cholecystectomy in 100 participants. Completed in 30 September 2017.

Timeline
1 April 2017
Primary endpoint
30 September 2017
30 September 2017

Quick facts

Lead sponsorClinical Research Centre, Malaysia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment100
Start date1 April 2017
Primary completion30 September 2017
Estimated completion30 September 2017
Sites1 location across Malaysia

Drugs / interventions tested

Conditions studied

Sponsor

Clinical Research Centre, Malaysia

Who can join

18 and older, any sex, with Complication Laparoscopic Cholecystectomy or Conversion Laparoscopic to Open Cholecystectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal surgery in Western countries. Ever since the introduction of laparoscopic surgery in the late 1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the introduction and refinement of other laparoscopic abdominal surgeries have rapidly progressed due to the early experience and safety profile seen in LC. The introduction of stereoscopes which allow for 3D visual feedback has been postulated to overcome setbacks encountered in conventional 2-dimensional (2D) laparoscopic surgery. Since its introduction in the mid-2000s, 3D visualisation has been proven to be advantageous over 2D visualisation, especially so within the context of training junior surgeons in controlled, experimental settings. The body of evidence on benefits of 3D visualisation within the clinical setting, i.e. when applied on live patients in operating theatres, remains small and weak. The previous publications however did not extrapolate any potential benefits on patients' well-being in correlation to their reported benefits and neither did they explore any potential benefits in reducing operative complications. We decided to embark on a study to investigate any peri-operative advantage conferred on junior surgeons in performing LC using 3D visualisation as the majority of LCs in Sibu Hospital are carried out by junior surgeons.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Clinical Research Centre, Malaysia trials

Trials by the same sponsor.

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Data sources for this page

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