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Enrolling by Invitation

NCT Number: NCT06556498

Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair

there are currently two methods for fixation free laparoscopic inguinal hernia repair specifically based on the intrinsic properties of the device used. The Progrip mesh technique leaves the hernia orifice patent and relies on the established principle of strengthening the groin through scar tissue incorporation induced by foreign body reaction. In contrast, the ProFlor concept introduces a 3D dynamic regenerative scaffold that permanently obliterates the defect and regenerates the herniated inguinal barrier. This report presents the outcomes of laparoscopic techniques employing Progrip and ProFlor in randomized clinical trial. The results of this clinical study may have the potential to pave the way for innovative advancements in hernia repair techniques.

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Key information

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Italy

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • bilateral inguinal hernia

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 >34

Treatment and study plan

Proflor group

Procedure

evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Proflor mesh.

Progrip group

Procedure

evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Progrip mesh.

Primary outcomes

  1. postoperative adverse events

    Time frame: 30-postoperative days

    postoperative adverse events. The primary objective of these evaluations was to detect any possible complications that may have arisen, including but not limited to recurrence, hematoma, seroma, testicular swelling, wound infection/abscesses, prosthesis displacement, or any other complication. We used clinical observation and radiological findings to detect these complications.

Secondary outcomes

  1. Visual analogue score (VAS)

    Time frame: 1 - 6- 12 and 24 months

    The secondary endpoints included evaluations of postoperative pain. During follow-up control, patients were tasked with completing questionnaires aimed at evaluating their clinical conditions. To assess pain levels during the early stage (until four weeks postop.), the Visual Analogue Score (VAS) was employed. The VAS score is a widely recognized tool that enables patients to rate their pain on a scale from 0 to 10, where 0 signifies no pain and 10 indicates the most severe pain imaginable.

  2. Carolinas Comfort Scale (CCS)

    Time frame: 1 - 6- 12 and 24 months

    The secondary endpoints included evaluations of discomfort and quality of life. During follow-up control, patients were tasked with completing questionnaires aimed at evaluating their clinical conditions. For long-term clinical evaluation starting from four weeks postop, patients were instructed to fill out the Carolinas Comfort Scale questionnaire (CCS), regarded as the optimal scoring system for discomfort, and other postoperative symptoms. The CCS questionnaire offered a more thorough insight into the patient's experience and facilitated the evaluation of their long-term outcomes.

    The CCS is a 23-itemquestionnaire that quantifies the severity of pain, mesh sensation, and movement limitation from the hernia or surgical site during the following 8 activities: lying down, bending over, sitting up, activities of daily living, coughing or deep breathing (Min. 0 with no discomfort in all activity; Max. 115 with maximum discomfort in all activity)

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial: The ProPro Study

Acronym: ProPro

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

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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