3D HD Versus 2D HD in Cholecystectomy
Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in cholecystectomy in terms of error rating, performance time and subjective assessment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFebruary 28, 2017
February 1, 2017
2.5 years
March 12, 2015
February 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of errors during the dissection of the Calot´s triangle
The unedited videos of the operations will be assessed according to GERT (Generic Error Rating Tool) by three surgeons, blinded to which optical modalities is used during the operations as done in a previous pilot study.
Expected duration: 20 minutes
Secondary Outcomes (7)
Duration of the dissection of the Calot´s triangle
Expected duration: 20 minutes
Duration of surgery
Expected duration: 1 hour
The need for conversion to open surgery
intraoperative, expected duration of surgery: 1 hour
Estimated blood loss in ml
intraoperative, expected duration of surgery: 1 hour
Intraoperative complications
intraoperative, expected duration of surgery: 1 hour
- +2 more secondary outcomes
Study Arms (2)
2D HD laparoscopy
PLACEBO COMPARATORElective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode
3D HD laparoscopy
ACTIVE COMPARATORElective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode
Interventions
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective cholecystectomy (out-patient treatment)
You may not qualify if:
- Previous upper abdominal surgery
- ASA-score 3 or above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Herlev Hospital
Herlev, DK2730, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charlotte Fergo
Herlev Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Miss
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 24, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
February 28, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share