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

NCT01597011 | Completed

• 1 other identifier: BS12-000733
• Study Type: observational
• Target: 2,340
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal; Recurrence; Chronic Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Chronic pain

  Reported pain (questionnaire) from one year after procedure

  within period from one year after procedure until follow-up

Secondary Outcomes (2)

• Recurrence

  within period from procedure to follow-up

• dysejaculation

  Debut within period from procedure to follow-up

Study Arms (2)

Fibrin sealant group

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

Procedure: Fibrin Sealant

Tissue-penetrating fixation group

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

Procedure: Tissue-penetrating mesh-fixation

Interventions

Fibrin Sealant PROCEDURE

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

Also known as: Tisseel, Fibrin glue

Fibrin sealant group

Tissue-penetrating mesh-fixation PROCEDURE

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

Also known as: Protacks, Hernia stapler

Tissue-penetrating fixation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• inguinal hernia repair from January 2009-September 2012

You may not qualify if:

• Patients lost to follow-up

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Hernia, Inguinal; Recurrence; Chronic Pain

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Neel M Helvind, Researcher

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

• Jacob Rosenberg, professor

  Herlev Hospital

  STUDY CHAIR

• Andreas Q Fenger, Researcher

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc.Med.

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 11, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

DK (1)