Evidence map›Paper›PMID 27310955›Full record

Trial reportMedicine2016

Immunological reaction and oxidative stress after light or heavy polypropylene mesh implantation in inguinal hernioplasty: A CONSORT-prospective, randomized, clinical trial.

Marcello Donati, Giovanna Brancato, Giuseppe Grosso, Giovanni Li Volti, Giuseppina La Camera, Francesco Cardì, Francesco Basile, Angelo Donati

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01090284 (The Immunologic Reaction to Polypropylene Mesh Implantation), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 7% of its field
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.

NCT01090284 unknown statusnot on this map

The Immunologic Reaction to Polypropylene Mesh Implantation: a Comparison Between Heavyweight and Lightweight Mesh.

TypeobservationalSponsorUniversity Hospital, CataniaRan2010 to 2010Enrolled60ConditionsInguinal HerniaArmsInguinal hernioplasty
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Marcello DonatiDepartment of Surgery and Medical-Surgical Specialties, Vittorio-Emanuele University Hospital of Catania, Catania, Italy Department "G.F. Ingrassia," Section of Hygiene and Public Health, University of Catania, Catania, Italy Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy Department of Stress Biology, Epigenetic and Biomarkers, EuroMediterranean Institute of Science and Technology, Palermo, Italy Department of Surgical Sciences, Organ Transplants and New Technologies, General Surgery and Week Hospital Unit, University Hospital of Catania, Catania, Italy.
Giovanna Brancato
Giuseppe Grosso
Giovanni Li Volti
Giuseppina La Camera
Francesco Cardì
Francesco Basile
Angelo Donati
Patients First · USAzienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledThe relationship between mesh weight and host tissue reaction has, so far, not been fully investigated. Lightweight meshes (LWM) are thought to give less inflammatory response compared with heavyweight meshes (HWM). The present study is a randomized, controlled, double-blind clinical trial performed in 61 patients who underwent an elective inguinal hernioplasty. The primary outcome of the study was to investigate the relationship between total amount of prosthetic material (polypropylene), immunological reaction, and oxidative stress. The study was double-blinded. Sixty-one patients were recruited for the study and randomly assigned to 2 groups (groups A and B). Levels of inflammation markers (interleukin-6 [IL-6] and tumor necrosis factor-α [TNF-α]) and oxidative stress markers (reduced glutathione [GSH] and lipid hydroperoxides [LOOH]) were determined preoperatively and after undergoing inguinal hernioplasty (after 6, 72, and 288 hours), respectively, with LWM and HWM. There was no significant difference in IL-6 levels between HWM and LWM (P = 0.3, 0.7, 0.8 after 6, 72, and 288 hours, respectively). A statistically significant difference was found after 72 hours for TNF-α (P = 0.01), for GSH after 6 hours (P < 0.01), and after 6 and 72 hours for LOOH (P = 0.05, 0.01, respectively). Oxidative stress occurred at earlier time points and was pore accentuated HWM versus LWM and prodromal to TNF-α increase.Also, in randomized clinical trial, the use of LWM gives advantages in terms of less inflammatory response when compared with HWM. Moreover, there is a significant higher oxidative stress after implantation of HWM. The intensity of oxidative stress seems to be strongly related to the amount of implanted polypropylene. ( TRIAL REGISTRATION NUMBER: NCT01090284).

Indexed as

Oxidative StressAdolescentAdultAgedAged, 80 and overCytokinesDouble-Blind MethodFemaleFollow-Up StudiesHernia, InguinalHerniorrhaphyHumansInflammationMaleMiddle AgedPolypropylenesCytokinesPolypropylenes

Identifiers

PMID27310955
PMCPMC4998441
OpenAlexW2443923789

What OpenQuestion holds

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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.