Back to results3D vs 2D HD Laparoscopy in Cholecystectomy
Primary Purpose
Cholecystolithiasis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
2D laparoscopic cholecystectomy
3D laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystolithiasis focused on measuring 3D, laparoscopy, cholecystectomy
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for laparoscopic cholecystectomy
Exclusion Criteria:
- Some other surgical operation planned during LCC
- Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis)
- Operating surgeon experience less than 5 3D laparoscopy operations
Sites / Locations
- Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2D laparoscopic cholecystectomy
3D laparoscopic cholecystectomy
Arm Description
The normal laparoscopic cholecystectomy with two dimensional view
The normal laparoscopic cholecystectomy with three dimensional view
Outcomes
Primary Outcome Measures
Duration of surgery
Secondary Outcome Measures
Need for conversion into open surgery
Intraoperative complications
Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture
Complications, Clavien-Dindo classification
Postoperative stay in hospital
Bleeding
Number of participants with readmission(s)
Total need of opioids in milligrams
Mortality
Operation theatre time
Postoperative pain, VAS
Full Information
NCT ID
NCT02357589
First Posted
February 3, 2015
Last Updated
August 27, 2017
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02357589
Brief Title
3D vs 2D HD Laparoscopy in Cholecystectomy
Official Title
3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 10, 2017 (Actual)
Study Completion Date
May 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
5. Study Description
Brief Summary
The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
Keywords
3D, laparoscopy, cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2D laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
The normal laparoscopic cholecystectomy with two dimensional view
Arm Title
3D laparoscopic cholecystectomy
Arm Type
Experimental
Arm Description
The normal laparoscopic cholecystectomy with three dimensional view
Intervention Type
Procedure
Intervention Name(s)
2D laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
3D laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Duration of surgery
Time Frame
Expected average time of surgery 1 hour
Secondary Outcome Measure Information:
Title
Need for conversion into open surgery
Time Frame
During the operation, expected average time of surgery 1 hour
Title
Intraoperative complications
Description
Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture
Time Frame
During the operation, expected average time of surgery 1 hour
Title
Complications, Clavien-Dindo classification
Time Frame
30 days after randomization
Title
Postoperative stay in hospital
Time Frame
Expected range 0-7 day
Title
Bleeding
Time Frame
During the operation, expected average time of surgery 1 hour
Title
Number of participants with readmission(s)
Time Frame
30 days after randomization
Title
Total need of opioids in milligrams
Time Frame
Expected range 0-7 day
Title
Mortality
Time Frame
30 days after randomization
Title
Operation theatre time
Time Frame
Expected average 1,5 hours
Title
Postoperative pain, VAS
Time Frame
Expected range 0-7 day
Other Pre-specified Outcome Measures:
Title
Incisional hernias
Time Frame
after 1, 5 and 10 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for laparoscopic cholecystectomy
Exclusion Criteria:
Some other surgical operation planned during LCC
Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis)
Operating surgeon experience less than 5 3D laparoscopy operations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Sallinen, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30710315
Citation
Koppatz H, Harju J, Siren J, Mentula P, Scheinin T, Sallinen V. Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study. Surg Endosc. 2019 Nov;33(11):3725-3731. doi: 10.1007/s00464-019-06666-5. Epub 2019 Feb 1.
Results Reference
derived
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3D vs 2D HD Laparoscopy in Cholecystectomy
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