Clinical Trial: 3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Helsinki University Central Hospital

Current Primary Outcome: Duration of surgery [ Time Frame: Expected average time of surgery 1 hour ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need for conversion into open surgery [ Time Frame: During the operation, expected average time of surgery 1 hour ]
  • 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
  • Complications, Clavien-Dindo classification [ Time Frame: 30 days after randomization ]
  • Postoperative stay in hospital [ Time Frame: Expected range 0-7 day ]
  • Bleeding [ Time Frame: During the operation, expected average time of surgery 1 hour ]
  • Number of participants with readmission(s) [ Time Frame: 30 days after randomization ]
  • Total need of opioids in milligrams [ Time Frame: Expected range 0-7 day ]
  • Mortality [ Time Frame: 30 days after randomization ]
  • Operation theatre time [ Time Frame: Expected average 1,5 hours ]
  • Postoperative pain, VAS [ Time Frame: Expected range 0-7 day ]


Original Secondary Outcome: Same as current

Information By: Helsinki University Central Hospital

Dates:
Date Received: February 9, 2015
Date Started: January 2015
Date Completion: January 2020
Last Updated: April 22, 2017
Last Verified: April 2017