Hernia, Hernia, Inguinal
Conditions
Keywords
3D, Three-dimensional, Laparoscopy, Inguinal hernia repair
Brief summary
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
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.
Interventions
DEVICE3D HD laparoscopy
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
DEVICE2D HD laparoscopy
Placebo
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for elective inguinal hernia repair (out-patient treatment)
Exclusion criteria
* Previous lower abdominal surgery * ASA-score 3 or above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of errors during the dissection of the hernia sac | Expected duration: 20 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Duration of the dissection of the hernia sac. | Expected duration: 20 minutes | — |
| Assessment of fatigue and perceived exertion | an expected average of 15 minutes before and after the operation | Subjective assessment. The surgeon will fill out questionnaires and scales |
| Evaluation of the optical modality and mental load assessment | an expected average of 15 minutes after the operation | Subjective assessment. The surgeon will fill out questionnaires and scales |
| Intraoperative complications | intraoperative, expected duration of surgery: 1 hour | — |
Countries
Denmark
Contacts
Primary ContactCharlotte Fergo
Outcome results
None listed