NCT02507830

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

July 20, 2015

Last Update Submit

March 2, 2016

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain (Evaluation will be conducted through scale and a questionnaire )

    2 years

Secondary Outcomes (2)

  • Hernia recurrence (Evaluation will be conducted through a questionnaire and physical examination )

    2 years

  • Postoperative complications (Evaluation will be conducted through a questionnaire and physical examination )

    2 years

Study Arms (1)

Glubran 2 fixation

Mesh fixation with Glubran 2 glue in primary inguinal hernia repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults older than 18 undergoing a primary inguinal hernia repair

You may qualify if:

  • Primary Inguinal hernia

You may not qualify if:

  • Recurrent hernia
  • Large inguinoscrotal hernias
  • Bilateral inguinal hernias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Adel Abu_Salih, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adel Abu_Salih, MD

CONTACT

972-4-8541308a_abu_salih@rambam.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 24, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

IL(1)