Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proflor group, Progrip group.
- Who it may be relevant to
- Registry conditions: Hernia, Inguinal, Laparoscopic Surgery. Basic parameters: 18 years — 85 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial: The ProPro Study
Overview
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.
Interventions
- Procedure Proflor group
evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Proflor mesh. - Procedure Progrip group
evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Progrip mesh.
Primary outcome measures
- postoperative adverse events [Time frame: 30-postoperative days]
Secondary outcome measures (2)
- Visual analogue score (VAS) [Time frame: 1 - 6- 12 and 24 months]
- Carolinas Comfort Scale (CCS) [Time frame: 1 - 6- 12 and 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Italy — Palermo
Publications
- 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
Identifiers
NCT: NCT06556498 · ProPro study