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The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair

This study is currently recruiting participants.
Verified May 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01596049
First received: May 9, 2012
Last updated: May 28, 2012
Last verified: May 2012
History of Changes
  Purpose

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.

The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.

The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).


Condition Intervention
Primary Inguinal Hernia
Unilateral Hernia
Open Surgery
 Device: Self-fixating Mesh

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair, in Comparison to the Standard Treatment in the Literature

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Percentage of post operative inguinal Hernia recurrence. [ Time Frame: 2 weeks, 3,6,12,24 months post-operative ] [ Designated as safety issue: No ]
  • Post-operative patient quality of life will be assessed using a validated questionnaire. [ Time Frame: 2 weeks, 3,6,12,24 months post-operative ] [ Designated as safety issue: No ]
  • Pain will be assessed by NRS (Numerical Rating Scale) [ Time Frame: 2 weeks, 3,6,12,24 months post-operative ] [ Designated as safety issue: No ]
  • Post-operative complications will be assessed using a validated questionnaire. [ Time Frame: 2 weeks, 3,6,12,24 months post-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Self-fixating Mesh
patients attributed to that arm, undergoing surgery of open inguinal unilateral hernia repair, using Self-fixating Mesh which is acceptable in the literature.
 Device: Self-fixating Mesh
Using Self-fixating Mesh for Inguinal Hernia Repair

Detailed Description:

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.

The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.

The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients who are undergoing Inguinal Hernia Repair Surgery.

Criteria

Inclusion Criteria:

  • All patients undergoing primary unilateral open Inguinal Hernia Repair .
  • patients undergoing elective surgery.
  • above the age of 18 years old

Exclusion Criteria:

  • patients having repeated Inguinal Hernia.
  • patients having bilateral Hernia.
  • patients undergoing laparoscopic surgery.
  • patients undergoing non-elective surgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596049

Contacts
Contact: Adel Abu_Salih, M.D 972-48541308 a_abu_salih@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Adel Abu_Salih, M.D     972-48541308     a_abu_salih@rambam.health.gov.il    
Rambam health care campus Recruiting
Hifa, Israel
Contact: Adel Abu_salih, M.D     972-48541308     a_abu_salih@rambam.health.gov.il    
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Adel Abu_Salih, M.D Rambam health care campus, Haifa, Israel
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01596049     History of Changes
Other Study ID Numbers: hernia313-11-RMBCTIL
Study First Received: May 9, 2012
Last Updated: May 28, 2012
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 23, 2013