Hernia, InguinalPhase 4ProProNCT06556498

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

A Phase 4 study testing Proflor group and Progrip group in people with Hernia, Inguinal and Laparoscopic Surgery, run by University of Palermo at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years, men only
Conditions the study is for: Hernia, Inguinal, Laparoscopic Surgery
What is being tested?: Proflor group and Progrip group
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteItaly
Study dates: 1 Jan 2021to 31 Dec 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

bilateral inguinal hernia

Who cannot join

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

Show all 13Show fewer

Pregnant
Active drug user
Immunosuppression, chemotherapy
Chronic renal insufficiency
Abdominal ascites
Infection in area of the surgical field
BMI >34

Trial locations and contacts

1 site in 1 country.

Italy1 site

Italy
Palermo, 90127

Other trials in Italy

About this study

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

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
Being tested: Proflor group, Progrip group
Keywords: hernia surgery, inguinal hernia, fixation free repair, TAPP, laparoscopic surgery
Medical subject headings: Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06556498
Study group	Role	What they receive
ProFlor group	Active comparator	patients underwent to laparoscopic hernia repair with the use of ProFlor mesh Receives: Procedure: Proflor group
Progrip group	Active comparator	patients underwent to laparoscopic hernia repair with the use of Progrip mesh Receives: Procedure: Progrip group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30-postoperative days

Secondary outcomes (2)

Visual analogue score (VAS)
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.
Measured: 1 - 6- 12 and 24 months
Carolinas Comfort Scale (CCS)
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)
Measured: 1 - 6- 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202131 Dec 2025

First posted16 Aug 2024
Study start1 Jan 2021
Primary completion31 Dec 2023
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hernia, InguinalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: we use progrip mesh and proflor mesh in different arms of patients
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06556498
Sponsor's protocol ID: ProPro study
Acronym: ProPro
Status last verified: Aug 2024
First submitted: 29 Jun 2024
Last updated: 16 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 40167608

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
Recruiting
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias

All Hernia, Inguinal trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial: The ProPro Study
ClinicalTrials.gov ID: NCT06556498
Acronym / sponsor ID: ProPro / ProPro study
Conditions: Hernia, Inguinal, Laparoscopic Surgery
Keywords: hernia surgery, inguinal hernia, fixation free repair, TAPP, laparoscopic surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: University of PalermoUniversity, hospital or other
Study start: 1 Jan 2021 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2025 (estimated)
First posted: 16 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: we use progrip mesh and proflor mesh in different arms of patients

Arm	Type	Receives
ProFlor group	Active comparator	Procedure: Proflor grouppatients underwent to laparoscopic hernia repair with the use of ProFlor mesh
Progrip group	Active comparator	Procedure: Progrip grouppatients underwent to laparoscopic hernia repair with the use of Progrip mesh

Who may qualify

Ages: 18 to 85 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

bilateral inguinal hernia

Key exclusion criteria (13 listed)

Recurrent inguinal hernia
Incarcerated inguinal hernia
Hernia not in the inguinal area
Signs of obvious local or systemic infection
ASA score > 4

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Proflor groupevaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Proflor mesh.	Procedure or surgery	ProFlor group
Progrip groupevaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Progrip mesh.	Procedure or surgery	Progrip group

Primary outcome

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.

2 secondary outcomes

Visual analogue score (VAS)
Time frame: 1 - 6- 12 and 24 months
Carolinas Comfort Scale (CCS)
Time frame: 1 - 6- 12 and 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
Derived from this study: PubMed 40167608Di 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.
Individual participant dataSharing planned: No

Related trials for Hernia, Inguinal

Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
Recruiting
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giuseppe Di Buono principal investigator

University of Palermo

Antoninoq Agrusa study director

University of Palermo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Proflor group and Progrip group in people with Hernia, Inguinal and Laparoscopic Surgery, run by University of Palermo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative adverse events (time frame: 30-postoperative days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06556498, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.