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OpenTrials
Completed

NCT Number: NCT02367573

3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

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.

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2D laparoscopic TAPP inguinal hernia repair

Procedure

3D laparoscopic TAPP inguinal hernia repair

Procedure

Primary outcomes

  1. Duration of surgery

    Time frame: Expected average time of surgery 1 hour

Secondary outcomes

  1. Need for conversion into open surgery

    Time frame: During the operation, expected average time of surgery 1 hour

  2. Intraoperative complications

    Time frame: During the operation, expected average time of surgery 1 hour

    Any complication during the operation e.g. hemorrhagic, intestine or bladder rupture

  3. Complications, Clavien-Dindo classification

    Time frame: 30 days after randomization

  4. Postoperative stay in hospital

    Time frame: Expected range 0-7 day

  5. Bleeding

    Time frame: During the operation, expected average time of surgery 1 hour

  6. Number of participants with readmission(s)

    Time frame: 30 days after randomization

  7. Total need of opioids in milligrams

    Time frame: Expected range 0-7 day

  8. Mortality

    Time frame: 30 days after randomization

  9. Operation theatre time

    Time frame: Expected average 1,5 hours

  10. Postoperative pain, VAS

    Time frame: Expected range 0-7 day

Other outcomes

  1. Incisional hernias

    Time frame: after 1, 5 and 10 year

  2. Inguinal hernia recurrence

    Time frame: after 1, 5 and 10 year

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

3D Versus 2D HD Laparoscopy in Inguinal Hernia Repair: a Prospective, Single Blinded, Randomized, Controlled Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2015
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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