Trial reportHNO2013
[A novel puncture instrument: the Provox-Vega® puncture set. Its use in voice prosthesis insertion following laryngectomy].
Trial report in HNO, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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.
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.
Who cites it
4 citing papers in PubMed, 9 citations in OpenAlex.
- Rehabilitation after Total Laryngectomy-A Tribute to the Pioneers of Voice Restoration in the Last Two Centuries.Frontiers in medicine · 2017Review
- [Voice rehabilitation after total laryngectomy: A chronological review of medical history].HNO · 2015Review
- Total laryngectomy - past, present, future.Maedica · 2014Review
- Prosthetic rehabilitation of a total laryngectomy patient.Journal of Indian Prosthodontic SocietyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20 years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses. PATIENTS AND
methodsOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21 patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.
resultsThe average surgical time was 83.5 (± 19.12) s for primary voice prosthesis insertion and 212.57 (± 93.03) s in secondary procedures. The prosthesis could be inserted without complication in 19 patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.
conclusionThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.
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Identifiers
What OpenQuestion holds
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.