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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02123719
Other study ID # 1304197302
Secondary ID
Status Completed
Phase N/A
First received April 24, 2014
Last updated April 24, 2014
Start date January 2013
Est. completion date February 2014

Study information

Verified date April 2014
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial Summary

Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.

Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant.

Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome parameters: - Hernia repair-related infection rate

- Postoperative morbidity Statistical analysis: Comparison of study versus control group, univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were considered significant.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Incisional hernia

- Laparoscopic repair possible

Exclusion Criteria:

- Other types of ventral hernias

- Laparoscopy not possible

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Surgery


Locations

Country Name City State
Austria Medical University Innsbruck Innsbruck Tyrol

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hernia recurrence post laparoscopic incisional hernia repair 1 - 74 months post surgery No