3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

Study Overview
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Brief Summary
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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.

Official Title
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3D Versus 2D HD Laparoscopy in Inguinal Hernia Repair: a Prospective, Single Blinded, Randomized, Controlled Trial

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: 2D laparoscopic TAPP inguinal hernia repair
* Procedure: 3D laparoscopic TAPP inguinal hernia repair


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D TAPP<br>Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with two dimensional view | Procedure: 2D laparoscopic TAPP inguinal hernia repair<br> <br> |
| Experimental: 3D TAPP<br>Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with three dimensional view | Procedure: 3D laparoscopic TAPP inguinal hernia repair<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery |  | Expected average time of surgery 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for conversion into open surgery |  | During the operation, expected average time of surgery 1 hour | 
| Intraoperative complications | Any complication during the operation e.g. hemorrhagic, intestine or bladder rupture | During the operation, expected average time of surgery 1 hour | 
| Complications, Clavien-Dindo classification |  | 30 days after randomization | 
| Postoperative stay in hospital |  | Expected range 0-7 day | 
| Bleeding |  | During the operation, expected average time of surgery 1 hour | 
| Number of participants with readmission(s) |  | 30 days after randomization | 
| Total need of opioids in milligrams |  | Expected range 0-7 day | 
| Mortality |  | 30 days after randomization | 
| Operation theatre time |  | Expected average 1,5 hours | 
| Postoperative pain, VAS |  | Expected range 0-7 day |