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

Not Applicable

• Conditions: Hernia, Inguinal; Hernia
• Interventions: Device: 2D HD laparoscopy; Device: 3D HD laparoscopy

• Registration Number: NCT02396940
• Lead Sponsor: Herlev Hospital

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2D HD laparoscopy	2D HD laparoscopy	Elective laparoscopic inguinal hernia repair performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode
3D HD laparoscopy	3D HD laparoscopy	Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Intraoperative complications	intraoperative, expected duration of surgery: 1 hour
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
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
Estimated blood loss in ml	intraoperative, expected duration of surgery: 1 hour

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark