Safety of Mesh Used Repairs in Emergency Abdominal Wall H... | NCT01578538

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

NCT01578538

Sponsor

SB Istanbul Education and Research Hospital

Status

Unknown status

Last Update Posted

Apr 17, 2012Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Hernia

Interventions

inguinal hernia repair

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
travma & emergency surgery	Registry Identifier	mcs

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Apr 13, 2012

First Submission Date that Met QC Criteria

Apr 16, 2012

First Posted Date

Apr 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2012

Last Update Posted Date

Apr 17, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erhan Aysan, prof. dr., SB Istanbul Education and Research HospitalPrincipal Investigator

Lead Sponsor

SB Istanbul Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mesh used repair	Active Comparator	mesh used hernia repair will be perform	Procedure: inguinal hernia repair
nonmesh	Active Comparator	nonmesh hernia repair techniques will be used	Procedure: inguinal hernia repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inguinal hernia repair	Procedure	strangulated hernias will be repaired surgically	mesh used repair nonmesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wound infection	surgical wound infection is the primary outcome measure of this trial	six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 16 years old,
Strangulated abdominal wall hernia
No any contrindications to operation

Exclusion Criteria:

Younger than 16 years old,
Non-strangulated abdominal wall hernis
Any causes of contrindications to operation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bezmialem Vakif University	Recruiting	Istanbul	Marmara	34543	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia
D004630	Emergencies

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided