NCT01467830

Brief Summary

The purpose of this study is to determine the efficacy of mesh fixation using absorbable versus non-absorbable sutures.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 30, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 4, 2014

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

October 30, 2011

Last Update Submit

July 3, 2014

Conditions

Inguinal Hernia

Keywords

absorbable sutures efficacyreducing Adverse effect to be caused from surgeryInguinal Hernia repair with mesh

Outcome Measures

Primary Outcomes (1)

  • Impact of absorbable sutures in inguinal hernia repair on hernia recurrence and post operative outcome

    Absorbable sutures efficacy will be assessed according to:severity of post surgical pain(using NRS-Numerical Rating Scale measure),hernia recurrence (assessed by physical examination during the follow-up period) and other post surgical complications such as nerve entrapment,hematoma and stich granuloma

    two years

Study Arms (2)

absorbable sutures

EXPERIMENTAL

patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using absorbable sutures.

Procedure: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

non absorbable sutures

OTHER

patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using non absorbable sutures,this is the method being considered the standard of care thus far.

Procedure: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

Interventions

Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation SuturesPROCEDURE

use of absorbable sutures to fixate mesh inguinal hernia repair.

absorbable suturesnon absorbable sutures

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients undergoing initial unilateral Open Inguinal Hernia Repair surgery.

You may not qualify if:

  • patients having repeated Inguinal Hernia or bilateral Hernia
  • patients undergoing laparoscopic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Adel Abu_salih, M.D

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2011

First Posted

November 9, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

July 4, 2014

Record last verified: 2011-12

Locations

IL(1)