Clinical Trial: Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)
Brief Summary:
To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial.
All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.
Detailed Summary:
Sponsor: University Hospital, Ghent
Current Primary Outcome: number of patients with a VAS scale more than 40 [ Time Frame: 1 year after surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- number of invasive interventions (local infiltrations, reoperations) postoperatively [ Time Frame: 1 year after surgery ]
- number of patients taking analgetics [ Time Frame: 1 year post-surgery ]
- perioperative morbidity rate [ Time Frame: 1 year after surgery ]
- quality of life [ Time Frame: 1 year post-surgery ]
- recurrence rate [ Time Frame: 1 year post-surgery ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Ghent
Dates:
Date Received: April 22, 2010
Date Started: April 2010
Date Completion: August 2015
Last Updated: December 4, 2014
Last Verified: December 2014
