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OpenTrials
Completed

NCT Number: NCT05706662

Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Palermo

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inguinal hernia repair with mesh

Procedure

inguinal hernia repair with mesh

Primary outcomes

  1. early postoperative complications

    Time frame: 30 days after surgery

    bleeding, hematoma and infections

  2. patients clinical outcome

    Time frame: 24 months

    VAS score

Secondary outcomes

  1. evaluation of quality of life during the postoperative period

    Time frame: 24 months

    Carolina Comfort Scale - CCS

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

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

Acronym: DYSLOH

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jan 31, 2023
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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