Level C· Early human research exploring benefitsRetrospective StudyPubMedOpen access

Regenerative Strategy for Persistent Periprosthetic Leakage around Tracheoesophageal Puncture: Is It an Effective Long-Term Solution?

Parrilla C., Almadori A., Longobardi Y., Lattanzi W., Salgarello M., Almadori G.

Retrospective Study on Autoimmune Research, published in Cells (2021) — summary generated from the PubMed abstract.

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Level C· Early human research exploring benefitsEvidence level of this study

Early human evidence such as case series or small samples is exploring possible benefits.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
Read the A–D evidence level guide

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Retrospective Study
Journal
Cells (2021)
Country
Switzerland
Reported sample size
—
Source database
PubMed
PMID
34359865
PMCID
PMC8305158
DOI
10.3390/cells10071695
Citations
5

Abstract (original English)

Autologous tissue-assisted regenerative procedures have been considered effective to close different types of fistula, including the leakage around tracheoesophageal puncture. The aim of this study was to retrospectively review 10 years of lipotransfer for persistent periprosthetic leakage in laryngectomized patients with voice prosthesis. Clinical records of patients who experienced periprosthetic leakage from December 2009 to December 2019 were reviewed. Patients receiving fat grafting were included. The leakage around the prosthesis was assessed with a methylene blue test. Twenty patients experiencing tracheoesophageal fistula enlargement were treated with fat grafting. At the one-month follow-up, all patients were considered improved with no leakage observed. At six months, a single injection was sufficient to solve 75% of cases (n 15), whereas 25% (n 5) required a second procedure. The overall success rate was 80% (n 16). Results remained stable for a follow-up of 5.54 ± 3.97 years. Fat grafting performed around the voice prosthesis, thanks to its volumetric and regenerative properties, is a valid and lasting option to solve persistent periprosthetic leakage.

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.
  • • Without an adequate control group, treatment effects cannot be separated from other factors.

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

How we grade evidence
Adipose TissueAdultAgedAged, 80 and overFemaleHumansLarynx, ArtificialMaleMiddle AgedProsthesis Failure

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