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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05706662
Other study ID # DySLOH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source University of Palermo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date December 31, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia. Exclusion Criteria: - Recurrent inguinal hernia - Incarcerated inguinal hernia - Hernia not in the inguinal area - Signs of obvious local or systemic infection - ASA score > 4 - Presenting with unstable angina or NYHA class of IV - Pregnant - Active drug user - Immunosuppression, chemotherapy - Chronic renal insufficiency - Abdominal ascites - Infection in area of the surgical field - BMI >35

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
inguinal hernia repair with mesh
inguinal hernia repair with mesh

Locations

Country Name City State
Italy University of Palermo Palermo

Sponsors (1)

Lead Sponsor Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary early postoperative complications bleeding, hematoma and infections 30 days after surgery
Primary patients clinical outcome VAS score 24 months
Secondary evaluation of quality of life during the postoperative period Carolina Comfort Scale - CCS 24 months
See also
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