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

Primary Purpose

Hernia, Inguinal, Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3D HD laparoscopy
2D HD laparoscopy
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring 3D, Three-dimensional, Laparoscopy, Inguinal hernia repair

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Herlev HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

2D HD laparoscopy

3D HD laparoscopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of the dissection of the hernia sac.
Duration of surgery
The need for conversion to open surgery
Estimated blood loss in ml
Intraoperative complications
Assessment of fatigue and perceived exertion
Subjective assessment. The surgeon will fill out questionnaires and scales
Evaluation of the optical modality and mental load assessment
Subjective assessment. The surgeon will fill out questionnaires and scales

Full Information

First Posted
March 12, 2015
Last Updated
March 1, 2018
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02396940
Brief Title
3D HD Versus 2D HD in Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial
Official Title
Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Inguinal Hernia Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Hernia
Keywords
3D, Three-dimensional, Laparoscopy, Inguinal hernia repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2D HD laparoscopy
Arm Type
Placebo Comparator
Arm Description
Elective laparoscopic inguinal hernia repair performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode
Arm Title
3D HD laparoscopy
Arm Type
Active Comparator
Arm Description
Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode
Intervention Type
Device
Intervention Name(s)
3D HD laparoscopy
Other Intervention Name(s)
Olympus 3D ENDOEYE FLEX
Intervention Description
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
Intervention Type
Device
Intervention Name(s)
2D HD laparoscopy
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of errors during the dissection of the hernia sac
Description
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.
Time Frame
Expected duration: 20 minutes
Secondary Outcome Measure Information:
Title
Duration of the dissection of the hernia sac.
Time Frame
Expected duration: 20 minutes
Title
Duration of surgery
Time Frame
Expected duration: 1 hour
Title
The need for conversion to open surgery
Time Frame
intraoperative, expected duration of surgery: 1 hour
Title
Estimated blood loss in ml
Time Frame
intraoperative, expected duration of surgery: 1 hour
Title
Intraoperative complications
Time Frame
intraoperative, expected duration of surgery: 1 hour
Title
Assessment of fatigue and perceived exertion
Description
Subjective assessment. The surgeon will fill out questionnaires and scales
Time Frame
an expected average of 15 minutes before and after the operation
Title
Evaluation of the optical modality and mental load assessment
Description
Subjective assessment. The surgeon will fill out questionnaires and scales
Time Frame
an expected average of 15 minutes after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients scheduled for elective inguinal hernia repair (out-patient treatment) Exclusion Criteria: Previous lower abdominal surgery ASA-score 3 or above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Fergo
Email
charlotte.sayaka.fergo@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Fergo
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
DK2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Fergo
Email
sayakafergo@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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