Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia

Incisional Hernia Clinical Trial

— IH01  

Official title:

Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314091
• Other study ID #: KonyaTRH
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: December 9, 2014
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Konya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional hernia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Incisional hernia

• Acceptance of the trial

Exclusion Criteria:

• BMI>40

• ASA score of 4

• Severe pulmonary or cardiac disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Procedure:
• onlay mesh hernioplasty

Locations

Country	Name	City	State
Turkey	Konya Training and Research Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence		3 years	No