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