3D HD Versus 2D HD in Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02396927
• Other study ID #: 3D_vs_2D_chol
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2015
• Last updated: February 26, 2017
• Start date: March 2015
• Est. completion date: September 2017

Study information

• Verified date: February 2017
• Source: Herlev Hospital
• Contact: Charlotte Fergo
• Email: charlotte.sayaka.fergo[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Conventional laparoscopy can be very challenging, especially with the requirement of converting the two-dimensional image of the operating field to a three-dimensional perception. This can potentially lead to a detrimental effect on the learning curve as well for the feasibility of the operation for the more inexperienced surgeon. In our hospital, the high frequency of cholecystectomy serves as a basis for the minimally experienced surgeons to explore whether three-dimensional laparoscopy provides a better ability for solving complex intraoperative tasks than the conventional laparoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for elective cholecystectomy (out-patient treatment)

Exclusion Criteria:

• Previous upper abdominal surgery

• ASA-score 3 or above

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gall Bladder Disease
• Gallbladder Diseases
• Gallstones
• Urinary Bladder Diseases

Intervention

Device:
• 3D HD laparoscopy
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
• 2D HD laparoscopy
Placebo

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of the dissection of the Calot´s triangle		Expected duration: 20 minutes
Secondary	Duration of surgery		Expected duration: 1 hour
Secondary	The need for conversion to open surgery		intraoperative, expected duration of surgery: 1 hour
Secondary	Estimated blood loss in ml		intraoperative, expected duration of surgery: 1 hour
Secondary	Intraoperative complications	e.g. leakage of bile, leakage of gallstone, injury to the bile ducts, injury to organs.	intraoperative, expected duration of surgery: 1 hour
Secondary	Subjective assessment (Assessment of fatigue and perceived exertion)	The surgeon will fill out questionnaires and scales.	an expected average of 15 minutes before and after the operation
Secondary	Subjective assessment (optical modality and mental load assessment)	The surgeon will fill out questionnaires and scales.	an expected average of 15 minutes after the operation