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NCT01578538 Clinical Trial

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

Hernia Clinical Trial

— hernia  

Official title:
Mesh Used Repairs in Emergency Abdominal Wall Hernias

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01578538
Other study ID # herni
Secondary ID travma & emergen
Status Recruiting
Phase N/A
First received April 13, 2012
Last updated April 16, 2012
Start date February 2012
Est. completion date June 2016

Study information
Verified date April 2012
Source SB Istanbul Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date June 2016
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• inguinal hernia repair
strangulated hernias will be repaired surgically

Locations
Country Name City State
Turkey Bezmialem Vakif University Istanbul Marmara

Sponsors (1)
Lead Sponsor Collaborator
SB Istanbul Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary wound infection surgical wound infection is the primary outcome measure of this trial six months Yes
See also
  Status Clinical Trial Phase
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Terminated NCT01305486 - A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation N/A
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Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00617357 - Repair of Infected or Contaminated Hernias N/A
Completed NCT00535990 - Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Withdrawn NCT00138957 - Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh N/A
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Completed NCT01132209 - Suture Techniques to Reduce the Incidence of The inCisional Hernia N/A
Completed NCT00032448 - Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients? Phase 3
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Active, not recruiting NCT02439060 - PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit) N/A
Completed NCT02238964 - Reinforcement of Closure of Stoma Site Phase 2/Phase 3
Completed NCT01727388 - Informativeness to Digital Rectal Examination Phase 3
Completed NCT01997619 - Biological Mesh Repair of Complex Hernias in High Risk Patients N/A