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

NCT06556498 | Enrolling By Invitation Phase 4 FDA Device

• 1 other identifier: ProPro study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia, Inguinal; Laparoscopic Surgery

Keywords

hernia surgery; inguinal hernia; fixation free repair; TAPP; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• postoperative adverse events

  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.

  30-postoperative days

Secondary Outcomes (2)

• Visual analogue score (VAS)

  1 - 6- 12 and 24 months

• Carolinas Comfort Scale (CCS)

  1 - 6- 12 and 24 months

Study Arms (2)

ProFlor group

ACTIVE COMPARATOR

patients underwent to laparoscopic hernia repair with the use of ProFlor mesh

Procedure: Proflor group

Progrip group

ACTIVE COMPARATOR

patients underwent to laparoscopic hernia repair with the use of Progrip mesh

Procedure: Progrip group

Interventions

Proflor group PROCEDURE

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

ProFlor group

Progrip group PROCEDURE

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

Progrip group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral inguinal hernia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Italy

Palermo, 90127, Italy

Location

Related Publications (1)

• Di Buono G, Romano G, Rodolico V, Amato G, Zanghi G, Romano G, Calo PG, Agrusa A. Progrip versus ProFlor: two fixation-free devices for laparoscopic inguinal hernia repair-the Pro/Pro study, a randomized clinical trial. Surg Endosc. 2025 May;39(5):3113-3126. doi: 10.1007/s00464-025-11680-x. Epub 2025 Apr 1.

  PMID: 40167608 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Study Officials

• Giuseppe Di Buono

  University of Palermo

  PRINCIPAL INVESTIGATOR

• Antoninoq Agrusa

  University of Palermo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Compared progrip mesh with proflor mesh
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Surgery

Model Details: we use progrip mesh and proflor mesh in different arms of patients

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: August 16, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)