Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will use prospectively collected data from the Danish Hernia Database to find the patients. The patients will be contacted using a questionnaire.

Official Title
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Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation

Conditions
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Hernia, Inguinal, Recurrence, Chronic Pain

Intervention / Treatment
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* Procedure: Fibrin Sealant
* Procedure: Tissue-penetrating mesh-fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inguinal hernia repair from January 2009-September 2012 Exclusion Criteria: Patients lost to follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibrin sealant group<br>Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation | Procedure: Fibrin Sealant<br>* Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,<br>* Other names: Fibrin glue;|
| Tissue-penetrating fixation group<br>Patients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation | Procedure: Tissue-penetrating mesh-fixation<br>* Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair<br>* Other names: Hernia stapler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain | Reported pain (questionnaire) from one year after procedure | within period from one year after procedure until follow-up | 

Secondary Outcome Measures

| Outcome Measure | 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 | Debut within period from procedure to follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia, Inguinal, Hernia repair, Fibrin Tissue Adhesive, Tisseel, Tissucol, Recurrence, Chronic Pain, Dysejaculation