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3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

H

Helsinki University Central Hospital (HUCH)

Status

Completed

Conditions

Hernia, Inguinal

Treatments

Procedure: 2D laparoscopic TAPP inguinal hernia repair
Procedure: 3D laparoscopic TAPP inguinal hernia repair

Study type

Interventional

Funder types

Other

Identifiers

NCT02367573
HUCH-328-150128

Details and patient eligibility

About

Inguinal hernia can be repaired laparoscopically. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. The three-dimensional laparoscopic systems are gradually entering the operating rooms. There are plenty of evidence of the benefits of 3D-system in laboratory conditions. However, no prospective randomized trials have been published in the clinical point of view. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal hernia repair.

Enrollment

278 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients scheduled for laparoscopic inguinal hernia repair

Exclusion criteria

  • Some other surgical operation planned during TAPP
  • Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis)
  • Operating surgeon experience less than 5 3D laparoscopy operations

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

278 participants in 2 patient groups

2D TAPP
Active Comparator group
Description:
Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with two dimensional view
Treatment:
Procedure: 2D laparoscopic TAPP inguinal hernia repair
3D TAPP
Experimental group
Description:
Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with three dimensional view
Treatment:
Procedure: 3D laparoscopic TAPP inguinal hernia repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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