3D HD Versus 2D HD in Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial

Study Overview
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Brief Summary
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The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in inguinal hernia repair in terms of error rating, performance time and subjective assessment.

Detailed Description
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Experimental studies have shown that even experienced surgeons gain from stereoscopy when solving both easy and complex tasks. Inguinal hernia repair is a specialist operation and the large flow makes this type of operation suitable for exploring any advantage of three-dimensional laparoscopy for the experienced surgeon.

Official Title
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Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Inguinal Hernia Repair.

Conditions
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Hernia, Inguinal, Hernia

Intervention / Treatment
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* Device: 3D HD laparoscopy
* Device: 2D HD laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective inguinal hernia repair (out-patient treatment) Exclusion Criteria: Previous lower abdominal surgery ASA-score 3 or above

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2D HD laparoscopy<br>Elective laparoscopic inguinal hernia repair performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode | Device: 2D HD laparoscopy<br>* Placebo<br>|
| Active Comparator: 3D HD laparoscopy<br>Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode | Device: 3D HD laparoscopy<br>* Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.<br>* Other names: Olympus 3D ENDOEYE FLEX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of errors during the dissection of the hernia sac | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the dissection of the hernia sac. |  | 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 | 
| Assessment of fatigue and perceived exertion | Subjective assessment. The surgeon will fill out questionnaires and scales | an expected average of 15 minutes before and after the operation | 
| Evaluation of the optical modality and mental load assessment | Subjective assessment. The surgeon will fill out questionnaires and scales | an expected average of 15 minutes after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D, Three-dimensional, Laparoscopy, Inguinal hernia repair