An observational study in Hernia, Inguinal, Recurrence and Chronic Pain, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Herlev Hospital · Observational
In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated.
The investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples.
The aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.
The study will use prospectively collected data from the Danish Hernia Database to find the patients. The patients will be contacted using a questionnaire.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 2,340 is above the median of 126 across 688 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be enrolled based on their registration in the Danish Hernia Database. All patients in the database who have undergone laparoscopic inguinal hernia repair from January 2009 to September 2012 will be included.
inguinal hernia repair from January 2009-September 2012
Exclusion Criteria:
Patients lost to follow-up
Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation
Procedure: Fibrin Sealant
Patients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation
Procedure: Tissue-penetrating mesh-fixation
Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,
Also known as: Tisseel, Fibrin glue
Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair
Also known as: Protacks, Hernia stapler
Chronic pain
Reported pain (questionnaire) from one year after procedure
Time frame: within period from one year after procedure until follow-up
Recurrence
Reherniation at repaired site. Defined as a clinically observable hernia or reoperation prior to follow-up
Time frame: within period from procedure to follow-up
dysejaculation
Reported ejaculatory dysfunction in male patients
Time frame: Debut within period from procedure to follow-up
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Herlev Hospital