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NCT02396940 Clinical Trial

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

Hernia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02396940
Other study ID # 3D_vs_2D_ing
Secondary ID
Status Recruiting
Phase N/A
First received March 12, 2015
Last updated March 1, 2018
Start date March 2015
Est. completion date December 2018

Study information
Verified date March 2018
Source Herlev Hospital
Contact Charlotte Fergo
Email charlotte.sayaka.fergo@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients scheduled for elective inguinal hernia repair (out-patient treatment)

Exclusion Criteria:

- Previous lower abdominal surgery

- ASA-score 3 or above

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 3D HD laparoscopy
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
• 2D HD laparoscopy
Placebo

Locations
Country Name City State
Denmark Herlev Hospital Herlev

Sponsors (1)
Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Duration of the dissection of the hernia sac. Expected duration: 20 minutes
Secondary Duration of surgery Expected duration: 1 hour
Secondary The need for conversion to open surgery intraoperative, expected duration of surgery: 1 hour
Secondary Estimated blood loss in ml intraoperative, expected duration of surgery: 1 hour
Secondary Intraoperative complications intraoperative, expected duration of surgery: 1 hour
Secondary 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
Secondary 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
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