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NCT05706662 Clinical Trial

Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

Inguinal Hernia Clinical Trial

— DYSLOH  

Official title:
The DySLOH Study: Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. A Comparative Outcome Assessment Between the Two Techniques.

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
  Status Clinical Trial Phase
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Recruiting NCT03904888 - Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair N/A
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Completed NCT02240550 - A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair N/A
Completed NCT01943760 - Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty Phase 4
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Active, not recruiting NCT00968773 - Rebound Hernia Repair Device Mesh Trial Phase 4
Completed NCT01000116 - Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP) N/A
Completed NCT01117337 - Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair Phase 4
Terminated NCT00226161 - Chronic Pain After Inguinal Herniorrhaphy N/A
Completed NCT05837013 - Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia N/A
Recruiting NCT05058378 - Correlation Between Spinal Anesthesia and Perfusion Index
Completed NCT01637818 - Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair N/A
Recruiting NCT05879770 - Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
Completed NCT05107986 - Laparoscopy in Complicated Groin Hernia
Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
Completed NCT04033055 - Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia. N/A