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

NCT ID: NCT01597011

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-09-30

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.

Conditions

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Hernia, Inguinal Recurrence Chronic Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fibrin sealant group

Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation

Fibrin Sealant

Intervention Type PROCEDURE

Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,

Tissue-penetrating fixation group

Patients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation

Tissue-penetrating mesh-fixation

Intervention Type PROCEDURE

Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair

Interventions

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Fibrin Sealant

Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,

Intervention Type PROCEDURE

Tissue-penetrating mesh-fixation

Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair

Intervention Type PROCEDURE

Other Intervention Names

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Tisseel Fibrin glue Protacks Hernia stapler

Eligibility Criteria

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Inclusion Criteria

inguinal hernia repair from January 2009-September 2012

Exclusion Criteria

Patients lost to follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Andreas Qwist Fenger

BSc.Med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neel M Helvind, Researcher

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Jacob Rosenberg, professor

Role: STUDY_CHAIR

Herlev Hospital

Andreas Q Fenger, Researcher

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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BS12-000733

Identifier Type: -

Identifier Source: org_study_id

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