NCT02396940

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

3.8 years

First QC Date

March 12, 2015

Last Update Submit

March 1, 2018

Conditions

Hernia, InguinalHernia

Keywords

3DThree-dimensionalLaparoscopyInguinal hernia repair

Outcome Measures

Primary Outcomes (1)

  • 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.

    Expected duration: 20 minutes

Secondary Outcomes (7)

  • 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

  • Estimated blood loss in ml

    intraoperative, expected duration of surgery: 1 hour

  • Intraoperative complications

    intraoperative, expected duration of surgery: 1 hour

  • +2 more secondary outcomes

Study Arms (2)

2D HD laparoscopy

PLACEBO COMPARATOR

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

Device: 2D HD laparoscopy

3D HD laparoscopy

ACTIVE COMPARATOR

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

Device: 3D HD laparoscopy

Interventions

3D HD laparoscopyDEVICE

Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.

Also known as: Olympus 3D ENDOEYE FLEX
3D HD laparoscopy
2D HD laparoscopyDEVICE

Placebo

2D HD laparoscopy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, DK2730, Denmark

RECRUITING

MeSH Terms

Conditions

Hernia, InguinalHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Charlotte Fergo

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Fergo

CONTACT

charlotte.sayaka.fergo@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Miss

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 24, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)