Evidence map›Paper›PMID 28827035›Full record

Trial reportEBioMedicine2017

Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial.

Gouya Ram-Liebig, Guido Barbagli, Axel Heidenreich, Dirk Fahlenkamp, Giuseppe Romano, Udo Rebmann, Diana Standhaft, Hermann van Ahlen, Samer Schakaki, Ulf Balsmeyer and 2 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in EBioMedicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. A hybrid combination ofFrontiers in urology · 2025
    Article
  5. Review
  6. Review
  7. Observational
  8. Review
  9. Article
  10. Advances in urethroplasty.Medical journal, Armed Forces India · 2023
    Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Regenerative medicine applications: An overview of clinical trials.Frontiers in bioengineering and biotechnology · 2022
    Review
  17. Review
  18. Article
  19. Article
  20. 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

12 authors.

Gouya Ram-LiebigUroTiss Europe GmbH, Otto-Hahn-Str.15, 44227 Dortmund, Germany. Electronic address: g.ram-liebig@urotiss.com.
Guido BarbagliCentro Chirurgico Toscana, Via dei Lecci, 22, 52100 Arezzo, Italy.
Axel HeidenreichUniversity Clinic and Policlinic for Urology, Kerpener Str. 62, 50937 Cologne, Germany.
Dirk FahlenkampZeisigwald Clinics Bethanien, Department of Urology, Zeisigwaldstrasse 101, 09130 Chemnitz, Germany.
Giuseppe RomanoUrology Unit, Ospedale del Valdarno, Santa Maria alla Gruccia, Piazza del Volontariato, 1, 52025 Montevarchi-Arezzo, Italy.
Udo RebmannDiakonissen Clinics Dessau, Department of Urology, Gropiusallee 3, 06846 Dessau-Roßlau, Germany.
Diana StandhaftDiakonissen Clinics Dessau, Department of Urology, Gropiusallee 3, 06846 Dessau-Roßlau, Germany.
Hermann van AhlenOsnabrueck Clinic, Department of Urology, Am Finkenhügel 1, 49076 Osnabrück, Germany.
Samer SchakakiOsnabrueck Clinic, Department of Urology, Am Finkenhügel 1, 49076 Osnabrück, Germany.
Ulf BalsmeyerZeisigwald Clinics Bethanien, Department of Urology, Zeisigwaldstrasse 101, 09130 Chemnitz, Germany.
Maria SpieglerSt. Hedwig Hospital, Department of Urology, Große Hamburger Strasse 5-11, 10115 Berlin, Germany.
Helmut KnispelSt. Hedwig Hospital, Department of Urology, Große Hamburger Strasse 5-11, 10115 Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHarvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length and severity (real-world data).

methods99 patients from eight centers with heterogenous urethroplasty experience levels were included in this prospective, non-interventional observational study. Primary and secondary outcomes were success rate (SR) and safety at 12 and 24months.

findingsAll but one patient had ≥1, 77.1% (64 of 83)≥2 and 31.3% (26 of 83)≥4 previous surgical treatments. Pre- and postoperative mean±SD peak flow rate (Qmax) were 8.3±4.7mL/s (n=57) and 25.4±14.7mL/s (n=51). SR was 67.3% (95% CI 57.6-77.0) at 12 and 58.2% (95% CI 47.7-68.7) at 24months (conservative Kaplan Meier assessment). SR ranged between 85.7% and 0% in case of high and low surgical experience. Simple proportions of 12-month and 24-month SR for evaluable patients in all centers were 70.8% (46 of 65) and 76.9% (30 of 39). Except for one patient, no oral adverse event was reported. INTERPRETATIONS: TEOMG is safe and efficient in urethroplasty.

Indexed as

Plastic Surgery ProceduresTissue EngineeringAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaleMiddle AgedMouth MucosaPostoperative ComplicationsProportional Hazards ModelsRecurrenceRisk FactorsATMPGraftOral mucosaReconstructionTissue engineeringUrethra stricture

Identifiers

PMID28827035
PMCPMC5605371

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.