NCT03143426

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

May 4, 2017

Last Update Submit

January 25, 2018

Conditions

Complication Laparoscopic CholecystectomyConversion Laparoscopic to Open Cholecystectomy

Keywords

3D laparoscopic cholecystectomyJunior surgeonsComplicationConversion

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    Intraoperative complications : Gallbladder perforation, adjacent organ injury, uncontrolled bleeding Post-operative : pain score, length of hospital stay, readmission, mortality

    6 months

Secondary Outcomes (2)

  • Operative Time

    6 months

  • Conversion to open cholecystectomy

    6 months

Study Arms (2)

3D laparoscopic cholecystectomy

EXPERIMENTAL

Laparoscopic cholecystectomy will be performed under 3D visualisation.

Procedure: 3D laparoscopic cholecystectomy

2D laparoscopic cholecystectomy

NO INTERVENTION

Laparoscopic cholecystectomy will be performed under 2D visualisation, the standard viewing method used during all laparoscopic surgeries currently.

Interventions

3D laparoscopic cholecystectomyPROCEDURE

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.

3D laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients scheduled to undergo elective LC

You may not qualify if:

  • Patients below 18 years-old
  • Patients who declined to join the study
  • Patients with contraindications to undergo laparoscopic surgery (e.g. congestive cardiac failure, severe respiratory disease, uncorrected coagulopathy)
  • Patients with acute cholecystitis, gallbladder neck adherent to main biliary tree or dense omental adhesion to gallbladder
  • Patients with gallbladder tumour (suspected or confirmed)
  • Patients with variant biliary anatomy
  • Patients who had defaulted follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sibu Hospital

Sibu, Sarawak, 96000, Malaysia

Location

Study Officials

  • Chan Hooi Chea, MS

    Ministry of Health, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

April 1, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)