Evidence map›Paper›PMID 40167608›Full record

Trial reportSurgical endoscopy2025

Progrip versus ProFlor: two fixation-free devices for laparoscopic inguinal hernia repair-the Pro/Pro study, a randomized clinical trial.

Giuseppe Di Buono, Giorgio Romano, Vito Rodolico, Giuseppe Amato, Guido Zanghì, Giorgio Romano, Pietro Giorgio Calò, Antonino Agrusa

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Surgical endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06556498 (Progrip Versus ProFlor), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06556498 phase4enrolling by invitationnot on this map

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

TypeinterventionalSponsorUniversity of PalermoRan2021 to 2025Enrolled150ConditionsHernia, Inguinal, Laparoscopic SurgeryArmsProflor group, Progrip group
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Giuseppe Di BuonoDepartment of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy. giuseppe.dibuono@unipa.it.ORCID http://orcid.org/0000-0001-9928-6448
Giorgio RomanoDepartment of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy.
Vito RodolicoDepartment PROMISE, Section Pathological Anatomy University of Palermo, Palermo, Italy.
Giuseppe AmatoDepartment of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy.
Guido ZanghìDepartment of General Surgery, University of Catania, Catania, Italy.
Giorgio RomanoPostgraduate School of General Surgery, University of Palermo, Palermo, Italy.
Pietro Giorgio CalòDepartment of Surgical Sciences, University of Cagliari, Cagliari, Italy.
Antonino AgrusaDepartment of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

TRIAL

designThis randomized, multicenter clinical trial evaluates laparoscopic bilateral inguinal hernia repair outcomes by comparing the Progrip self-fixating mesh to the ProFlor 3D dynamic regenerative scaffold.

methodsAdults aged 18-85 years with clinically diagnosed bilateral primary inguinal hernias were enrolled and randomized into two treatment groups (Progrip or ProFlor) using block randomization. Operative time, intra- and postoperative complications, recurrence rates, postoperative pain, and quality of life were assessed over a 24-month follow-up. The allocation was not blinded to investigators or patients.

resultsFrom January 2021 to June 2022, 150 patients underwent laparoscopic TAPP repair. Eighteen were lost to follow-up (5 in the ProFlor group, 13 in the Progrip group). A total of 132 patients (67 ProFlor, 65 Progrip) were analyzed. The ProFlor group demonstrated shorter operative times, fewer intra- and postoperative complications, and reduced early postoperative pain compared to the Progrip group. Patients in the ProFlor arm achieved faster recovery and earlier return to daily activities. Notably, none of the ProFlor patients experienced chronic pain, whereas 10.8% of Progrip patients developed this complication. Hernia recurrence was observed in 2 Progrip patients, while no recurrences were reported in the ProFlor™ group.

conclusionIn this randomized trial, both devices proved feasible and effective for laparoscopic repair of bilateral inguinal hernias. However, the ProFlor scaffold was associated with reduced postoperative pain, absence of chronic pain, and no recurrences during follow-up compared to Progrip. While these findings are encouraging, further studies with larger cohorts and longer-term follow-up are warranted to confirm the potential benefits of the ProFlor scaffold and its role in routine clinical practice.

trial registrationThis study was registered at ClinicalTrials.gov with number NCT06556498.

Indexed as

Hernia, InguinalHerniorrhaphyLaparoscopySurgical MeshAdolescentAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedOperative TimePostoperative PainQuality of LifeRecurrenceDynamic scaffoldHernia surgeryInguinal herniaLaparoscopic hernia repairLaparoscopyMesh

Identifiers

PMID40167608
PMCPMC12041049

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.