- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02367573
3D vs 2D HD Laparoscopy in Inguinal Hernia Repair
June 13, 2018 updated by: Hanna Koppatz, Helsinki University Central Hospital
3D Versus 2D HD Laparoscopy in Inguinal Hernia Repair: a Prospective, Single Blinded, Randomized, Controlled Trial
Inguinal hernia can be repaired laparoscopically.
In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment.
The three-dimensional laparoscopic systems are gradually entering the operating rooms.
There are plenty of evidence of the benefits of 3D-system in laboratory conditions.
However, no prospective randomized trials have been published in the clinical point of view.
Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal hernia repair.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
278
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Helsinki, Finland, 00029
- Helsinki University Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for laparoscopic inguinal hernia repair
Exclusion Criteria:
- Some other surgical operation planned during TAPP
- Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis)
- Operating surgeon experience less than 5 3D laparoscopy operations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2D TAPP
Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with two dimensional view
|
|
Experimental: 3D TAPP
Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with three dimensional view
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of surgery
Time Frame: Expected average time of surgery 1 hour
|
Expected average time of surgery 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days after randomization
|
30 days after randomization
|
|
Complications, Clavien-Dindo classification
Time Frame: 30 days after randomization
|
30 days after randomization
|
|
Number of participants with readmission(s)
Time Frame: 30 days after randomization
|
30 days after randomization
|
|
Need for conversion into open surgery
Time Frame: During the operation, expected average time of surgery 1 hour
|
During the operation, expected average time of surgery 1 hour
|
|
Postoperative stay in hospital
Time Frame: Expected range 0-7 day
|
Expected range 0-7 day
|
|
Bleeding
Time Frame: During the operation, expected average time of surgery 1 hour
|
During the operation, expected average time of surgery 1 hour
|
|
Total need of opioids in milligrams
Time Frame: Expected range 0-7 day
|
Expected range 0-7 day
|
|
Operation theatre time
Time Frame: Expected average 1,5 hours
|
Expected average 1,5 hours
|
|
Postoperative pain, VAS
Time Frame: Expected range 0-7 day
|
Expected range 0-7 day
|
|
Intraoperative complications
Time Frame: During the operation, expected average time of surgery 1 hour
|
Any complication during the operation e.g.
hemorrhagic, intestine or bladder rupture
|
During the operation, expected average time of surgery 1 hour
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incisional hernias
Time Frame: after 1, 5 and 10 year
|
after 1, 5 and 10 year
|
Inguinal hernia recurrence
Time Frame: after 1, 5 and 10 year
|
after 1, 5 and 10 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ville Sallinen, MD,PhD, Helsinki University Central Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
February 9, 2015
First Submitted That Met QC Criteria
February 12, 2015
First Posted (Estimate)
February 20, 2015
Study Record Updates
Last Update Posted (Actual)
June 14, 2018
Last Update Submitted That Met QC Criteria
June 13, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUCH-328-150128
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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