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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02396940
Date of registration:	12/03/2015
Prospective Registration:	No
Primary sponsor:	Herlev Hospital
Public title:	3D HD Versus 2D HD in Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial
Scientific title:	Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Inguinal Hernia Repair.
Date of first enrolment:	March 2015
Target sample size:	30
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT02396940
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	Charlotte Fergo
Address:
Telephone:
Email:	charlotte.sayaka.fergo@regionh.dk
Affiliation:

Name:	Charlotte Fergo
Address:
Telephone:
Email:	sayakafergo@hotmail.com
Affiliation:

Name:	Charlotte Fergo
Address:
Telephone:
Email:
Affiliation:	Herlev Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Previous lower abdominal surgery

- ASA-score 3 or above

Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hernia, Inguinal

Hernia

Intervention(s)

Device: 3D HD laparoscopy

Device: 2D HD laparoscopy

Primary Outcome(s)

Number of errors during the dissection of the hernia sac [Time Frame: Expected duration: 20 minutes]

Secondary Outcome(s)

Duration of the dissection of the hernia sac. [Time Frame: Expected duration: 20 minutes]

Assessment of fatigue and perceived exertion [Time Frame: an expected average of 15 minutes before and after the operation]

Duration of surgery [Time Frame: Expected duration: 1 hour]

Evaluation of the optical modality and mental load assessment [Time Frame: an expected average of 15 minutes after the operation]

Estimated blood loss in ml [Time Frame: intraoperative, expected duration of surgery: 1 hour]

Intraoperative complications [Time Frame: intraoperative, expected duration of surgery: 1 hour]

The need for conversion to open surgery [Time Frame: intraoperative, expected duration of surgery: 1 hour]

Secondary ID(s)

3D_vs_2D_ing

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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