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

March 1, 2018 updated by: Charlotte Fergo, Herlev Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3D HD laparoscopy
Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode
Device: 3D HD laparoscopy
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
Other Names:
  • Olympus 3D ENDOEYE FLEX
Placebo Comparator: 2D HD laparoscopy
Elective laparoscopic inguinal hernia repair performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode
Device: 2D HD laparoscopy
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of errors during the dissection of the hernia sac
Time Frame: 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.
Expected duration: 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: Expected duration: 1 hour
Expected duration: 1 hour
The need for conversion to open surgery
Time Frame: intraoperative, expected duration of surgery: 1 hour
intraoperative, expected duration of surgery: 1 hour
Estimated blood loss in ml
Time Frame: intraoperative, expected duration of surgery: 1 hour
intraoperative, expected duration of surgery: 1 hour
Duration of the dissection of the hernia sac.
Time Frame: Expected duration: 20 minutes
Expected duration: 20 minutes
Intraoperative complications
Time Frame: intraoperative, expected duration of surgery: 1 hour
intraoperative, expected duration of surgery: 1 hour
Assessment of fatigue and perceived exertion
Time Frame: an expected average of 15 minutes before and after the operation
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
Time Frame: an expected average of 15 minutes after the operation
Subjective assessment. The surgeon will fill out questionnaires and scales
an expected average of 15 minutes after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Charlotte Fergo, Herlev Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D_vs_2D_ing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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