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

Sponsor

Herlev Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01597011

Collaborator

(none)

2,340

Enrollment

Location

Duration (Months)

89.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal Recurrence Chronic Pain	Procedure: Fibrin Sealant Procedure: Tissue-penetrating mesh-fixation

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.

Study Design

Study Type:

Observational

Actual Enrollment :

2340 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Fibrin sealant group Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation	Procedure: Fibrin Sealant Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair, Other Names: Tisseel Fibrin glue
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 Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair Other Names: Protacks Hernia stapler

Arm

Intervention/Treatment

Fibrin sealant group

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

Procedure: Fibrin Sealant

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

Other Names:

Tisseel

Fibrin glue

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

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

Other Names:

Protacks

Hernia stapler

Outcome Measures

Primary Outcome Measures

Chronic pain [within period from one year after procedure until follow-up]
Reported pain (questionnaire) from one year after procedure

Secondary Outcome Measures

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