NCT01596049

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

5.3 years

First QC Date

May 9, 2012

Last Update Submit

August 17, 2017

Conditions

Primary Inguinal HerniaUnilateral HerniaOpen Surgery

Outcome Measures

Primary Outcomes (4)

  • Percentage of post operative inguinal Hernia recurrence.

    2 weeks, 3,6,12,24 months post-operative

  • Post-operative patient quality of life will be assessed using a validated questionnaire.

    2 weeks, 3,6,12,24 months post-operative

  • Pain will be assessed by NRS (Numerical Rating Scale)

    2 weeks, 3,6,12,24 months post-operative

  • Post-operative complications will be assessed using a validated questionnaire.

    2 weeks, 3,6,12,24 months post-operative

Study Arms (1)

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

Interventions

Self-fixating MeshDEVICE

Using Self-fixating Mesh for Inguinal Hernia Repair

Self-fixating Mesh

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who are undergoing Inguinal Hernia Repair Surgery.

You may qualify if:

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

You may not qualify if:

  • patients having repeated Inguinal Hernia.
  • patients having bilateral Hernia.
  • patients undergoing laparoscopic surgery.
  • patients undergoing non-elective surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

Study Officials

  • Adel Abu_Salih, M.D

    Rambam health care campus, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

IL(1)