Sponsor study identifier
interventional
100
1 country
1
Study Start
April 1, 2017
Actual (reported)Primary Completion
September 30, 2017
Actual (reported)Study Completion
September 30, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2017
Actual (reported)May 4, 2017
Actual (reported)May 8, 2017
Actual (reported)September 30, 2017
Actual (reported)September 30, 2017
Actual (reported)Complication rate
Intraoperative complications : Gallbladder perforation, adjacent organ injury, uncontrolled bleeding Post-operative : pain score, length of hospital stay, readmission, mortality
6 months
Operative Time
6 months
Conversion to open cholecystectomy
6 months
Laparoscopic cholecystectomy will be performed under 3D visualisation.
Laparoscopic cholecystectomy will be performed under 2D visualisation, the standard viewing method used during all laparoscopic surgeries currently.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sibu Hospital
Sibu, Sarawak, 96000, Malaysia
Chan Hooi Chea, MS
Ministry of Health, Malaysia
100 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2017
First Posted
May 8, 2017
Study Start
April 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 30, 2017
Actual (reported)Study Completion
September 30, 2017
Actual (reported)Last Updated
January 26, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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