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

Herlev Hospital

Status: Unknown

Conditions: Hernia, Inguinal; Hernia

Treatments: Device: 3D HD laparoscopy; Device: 2D HD laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02396940

3D_vs_2D_ing

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previous lower abdominal surgery
• ASA-score 3 or above

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

2D HD laparoscopy

Placebo Comparator group

Description:

Elective laparoscopic inguinal hernia repair performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode

Treatment:

Device: 2D HD laparoscopy

3D HD laparoscopy

Active Comparator group

Description:

Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode

Treatment:

Device: 3D HD laparoscopy