Mesh Fixation With a Synthetic Glue in Primary Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

Mesh Fixation With a Synthetic Glue in Primary Inguinal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02507830
• Other study ID #: Meshg2
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2015
• Last updated: March 2, 2016
• Start date: August 2015
• Est. completion date: July 2017

Study information

• Verified date: March 2016
• Source: Rambam Health Care Campus
• Contact: Adel Abu_Salih, MD
• Phone: 972-4-8541308
• Email: a_abu_salih[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.

The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.

Description:

Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.

The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary Inguinal hernia

Exclusion Criteria:

• Recurrent hernia

• Large inguinoscrotal hernias

• Bilateral inguinal hernias

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain (Evaluation will be conducted through scale and a questionnaire )		2 years	No
Secondary	Hernia recurrence (Evaluation will be conducted through a questionnaire and physical examination )		2 years	No
Secondary	Postoperative complications (Evaluation will be conducted through a questionnaire and physical examination )		2 years	No