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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D HD laparoscopy | Placebo Comparator | Elective laparoscopic inguinal hernia repair performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode |
|
| 3D HD laparoscopy | Active Comparator | Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D HD laparoscopy | Device | Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Fergo | Contact | charlotte.sayaka.fergo@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Charlotte Fergo | Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Recruiting | Herlev | DK2730 | Denmark |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 2D HD laparoscopy | Device | Placebo |
|
| 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 |