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Clinical Trials/NCT02396940
NCT02396940
Unknown
Not Applicable

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

Herlev Hospital1 site in 1 country30 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hernia, Inguinal
Sponsor
Herlev Hospital
Enrollment
30
Locations
1
Primary Endpoint
Number of errors during the dissection of the hernia sac
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charlotte Fergo

Miss

Herlev Hospital

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Evaluation of the optical modality and mental load assessment(an expected average of 15 minutes after the operation)
  • Estimated blood loss in ml(intraoperative, expected duration of surgery: 1 hour)

Study Sites (1)

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