Safety of Mesh Used Repairs in Emergency Abdominal Wall Hernias. Prospective Randomized Multicenter Trial

NCT ID: NCT01578538

Last Updated: 2012-04-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-06-30

Brief Summary

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Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.

Detailed Description

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Repairing of emergency (strangulated) abdominal wall hernias with mesh is controversary. Strangulated abdominal hernias are not clean surgical wounds so applying prostetic materials such as meshes are problematic. Using of prostetic materials in un-clean wounds (clean contaminated, contaminated and dirty) is not proposed. But in surgical practice meshed surgical repair techniques are using largeley. In this multicenter study we try to find the answer for emergency hernia repairs meshed or not.

Conditions

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Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mesh used repair

mesh used hernia repair will be perform

Group Type ACTIVE_COMPARATOR

inguinal hernia repair

Intervention Type PROCEDURE

strangulated hernias will be repaired surgically

nonmesh

nonmesh hernia repair techniques will be used

Group Type ACTIVE_COMPARATOR

inguinal hernia repair

Intervention Type PROCEDURE

strangulated hernias will be repaired surgically

Interventions

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inguinal hernia repair

strangulated hernias will be repaired surgically

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Older than 16 years old,
2. Strangulated abdominal wall hernia
3. No any contrindications to operation

Exclusion Criteria

1. Younger than 16 years old,
2. Non-strangulated abdominal wall hernis
3. Any causes of contrindications to operation
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SB Istanbul Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erhan Aysan

prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bezmialem Vakif University

Istanbul, Marmara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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adnan yuksel, prof

Role: primary

904531700

Other Identifiers

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travma & emergency surgery

Identifier Type: REGISTRY

Identifier Source: secondary_id

herni

Identifier Type: -

Identifier Source: org_study_id

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