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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01597011

Enrollment

2340

Registered

2012-05-11

Start date

2012-07-31

Completion date

2014-09-30

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Hernia, Inguinal, Recurrence

Keywords

Hernia, Inguinal, Hernia repair, Fibrin Tissue Adhesive, Tisseel, Tissucol, Recurrence, Chronic Pain, Dysejaculation

Brief summary

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

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

Interventions

PROCEDUREFibrin Sealant

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

PROCEDURETissue-penetrating mesh-fixation

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

inguinal hernia repair from January 2009-September 2012

Exclusion criteria

Patients lost to follow-up

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Recurrence	within period from procedure to follow-up	Reherniation at repaired site. Defined as a clinically observable hernia or reoperation prior to follow-up
dysejaculation	Debut within period from procedure to follow-up	Reported ejaculatory dysfunction in male patients

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026