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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin sealant group | Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation |
| |
| Tissue-penetrating fixation group | Patients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Sealant | Procedure | Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic pain | Reported pain (questionnaire) from one year after procedure | within period from one year after procedure until follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Reherniation at repaired site. Defined as a clinically observable hernia or reoperation prior to follow-up | within period from procedure to follow-up |
| dysejaculation | Reported ejaculatory dysfunction in male patients |
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Inclusion Criteria:
inguinal hernia repair from January 2009-September 2012
Exclusion Criteria:
Patients lost to follow-up
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Neel M Helvind, Researcher | Herlev Hospital | Principal Investigator |
| Jacob Rosenberg, professor | Herlev Hospital | Study Chair |
| Andreas Q Fenger, Researcher | Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D012008 | Recurrence |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Tissue-penetrating mesh-fixation | Procedure | Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair |
|
|
| Debut within period from procedure to follow-up |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |