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Completed

NCT Number: NCT01597011

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev Hospital

Herlev, 2730, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

inguinal hernia repair from January 2009-September 2012

Exclusion criteria

Patients lost to follow-up

Treatment and study plan

Fibrin Sealant

Procedure

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

Other names: Tisseel, Fibrin glue

Tissue-penetrating mesh-fixation

Procedure

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

Other names: Protacks, Hernia stapler

Primary outcomes

  1. Chronic pain

    Time frame: within period from one year after procedure until follow-up

    Reported pain (questionnaire) from one year after procedure

Secondary outcomes

  1. Recurrence

    Time frame: within period from procedure to follow-up

    Reherniation at repaired site. Defined as a clinically observable hernia or reoperation prior to follow-up

  2. dysejaculation

    Time frame: Debut within period from procedure to follow-up

    Reported ejaculatory dysfunction in male patients

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 11, 2012
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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