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

This study has been terminated.
(recruitment was not going well.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596049
First Posted: May 10, 2012
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  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:


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 ]
  • Post-operative patient quality of life will be assessed using a validated questionnaire. [ Time Frame: 2 weeks, 3,6,12,24 months post-operative ]
  • Pain will be assessed by NRS (Numerical Rating Scale) [ Time Frame: 2 weeks, 3,6,12,24 months post-operative ]
  • Post-operative complications will be assessed using a validated questionnaire. [ Time Frame: 2 weeks, 3,6,12,24 months post-operative ]

Enrollment: 7
Study Start Date: May 2012
Study Completion Date: August 2017
Primary Completion Date: August 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596049


Locations
Israel
Rambam Health Care Campus
Haifa, Israel
Rambam health care campus
Hifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Adel Abu_Salih, M.D Rambam health care campus, Haifa, Israel
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01596049     History of Changes
Other Study ID Numbers: hernia313-11-RMBCTIL
First Submitted: May 9, 2012
First Posted: May 10, 2012
Last Update Posted: August 22, 2017
Last Verified: August 2017

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