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

NCT ID: NCT01596049

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Primary Inguinal Hernia Unilateral Hernia Open Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Self-fixating Mesh

Intervention Type DEVICE

Using Self-fixating Mesh for Inguinal Hernia Repair

Interventions

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Self-fixating Mesh

Using Self-fixating Mesh for Inguinal Hernia Repair

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adel Abu_Salih, M.D

Role: PRINCIPAL_INVESTIGATOR

Rambam health care campus, Haifa, Israel

Locations

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Rambam health care campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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hernia313-11-RMBCTIL

Identifier Type: -

Identifier Source: org_study_id

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