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

NCT03143426 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-01-26

No results posted yet for this study

Summary

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.

Conditions

  • Complication Laparoscopic Cholecystectomy
  • Conversion Laparoscopic to Open Cholecystectomy

Interventions

PROCEDURE

3D laparoscopic cholecystectomy

Laparoscopic cholecystectomy will be performed under 3D visualization as opposed to 2D visualization (conventional method). 3D supposedly provide sharper view with better depth perception and therefore might lead to reduce complication rates.

Sponsors & Collaborators

  • Clinical Research Centre, Malaysia

    lead OTHER

Principal Investigators

  • Chan Hooi Chea, MS · Ministry of Health, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143426 on ClinicalTrials.gov