Clinical Trial: Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.

Brief Summary: This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.

Detailed Summary:
Sponsor: Polish Hernia Study Group

Current Primary Outcome:

  • Pain [ Time Frame: 7 days after the surgery ]
    Presence of pain 7 days after the surgery.
  • Pain [ Time Frame: 3 months after the surgery ]
    Presence of pain 3 months after the surgery.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Participants with Recurrences [ Time Frame: up to one year ]
    The recurrence rate in one year followup.
  • Number of Participants with complications. [ Time Frame: up to one year ]
    The description and percentage distribution of short and long term complications following surgery.
  • Pain intensity [ Time Frame: 7 days after the surgery ]
    Intensity of pain measured on a visual analogue scale 7 days after the surgery
  • Pain intensity [ Time Frame: 30 days after the surgery ]
    Intensity of pain measured on a visual analogue scale 30 days after the surgery
  • Pain intensity [ Time Frame: 3 months after the surgery ]
    Intensity of pain measured on a visual analogue scale 3 months after the surgery.
  • Pain intensity [ Time Frame: 6 months after the surgery ]
    Intensity of pain measured on a visual analogue scale 6 months after the surgery.


Original Secondary Outcome: Same as current

Information By: Polish Hernia Study Group

Dates:
Date Received: August 29, 2014
Date Started: November 2012
Date Completion:
Last Updated: September 5, 2014
Last Verified: September 2014