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A prospective randomized multicenter clinical trial of the Provox2 and Groningen Ultra Low Resistance voice prostheses in the rehabilitation of post-laryngectomy patients: a lifetime and preference study
- Source :
- Oral Oncology, 47(9), 895-899. Elsevier Limited, Oral Oncology, 47, 895-9, Harms, K, Post, W J, van de Laan, K T, van den Hoogen, F J A, Eerenstein, S E J & van Laan, B F A M 2011, ' A prospective randomized multicenter clinical trial of the Provox2 and Groningen Ultra Low Resistance voice prostheses in the rehabilitation of post-laryngectomy patients: A lifetime and preference study ', Oral Oncology, vol. 47, no. 9, pp. 895-899 . https://doi.org/10.1016/j.oraloncology.2011.04.004, Oral Oncology, 47(9), 895-899. ELSEVIER SCIENCE BV, Oral Oncology, 47, 9, pp. 895-9
- Publication Year :
- 2011
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Abstract
- To prospectively study patients' preference for and the lifetime of the Groningen Ultra Low Resistance (GULR) and Provox2 tracheo-esophageal shunt prosthesis (TESP, plural TESPs) in post-laryngectomy patients. Eighty post-laryngectomy patients were included in 4 oncological centers in the Netherlands. We used a repeated measures design study with 4 randomized groups in a partial cross-over design using 3 consecutive TESPs (3 intervals) in different orders. (Group 1: GULR-GULR-GULR; Group 2: GULR-GULR-Provox2; Group 3: Provox2-Provox2-GULR; and Group 4: Provox2-Provox2-Provox2). Replacement dates and reasons for replacement were monitored with questionnaires as were patients' preferences for GULR or Provox2. A great variability of lifetime within and between groups was seen. Mean lifetimes found (all groups and intervals added) were 106.2 and 102.7 days, and median lifetimes were 76 and 65 days for GULR and Provox2, respectively. Lifetime showed no significant differences between groups, intervals, and TESP types. Many patients dropped out due to reasons having to do with GULR-characteristics (n = 21). The main dropout reason was "high phonating resistance (HPR)" (57.1%). Only 10 patients preferred GULR. A significantly larger number of patients (n = 39, 79.6%) preferred Provox2 either by choice or by dropping out due to GULR-characteristics (P
- Subjects :
- Male
medicine.medical_specialty
Cancer Research
Patient Dropouts
CARCINOMA
TOTAL LARYNGECTOMY
medicine.medical_treatment
Groningen Ultra Low Resistance
Laryngectomy
Aetiology, screening and detection [ONCOL 5]
Prosthesis Design
Prosthesis
Preference
Internal medicine
Surveys and Questionnaires
Perception and Action [DCN 1]
medicine
Humans
Prospective Studies
Laryngeal Neoplasms
RESTORATION
Netherlands
Rehabilitation
business.industry
Repeated measures design
Surgery
Prosthesis Failure
Clinical trial
Equipment Failure Analysis
Oncology
Patient Satisfaction
High phonating resistance
Provox2
EXPERIENCE
Female
Tracheo-esophageal shunt prosthesis
Oral Surgery
Low resistance
business
Larynx, Artificial
Lifetime
Subjects
Details
- ISSN :
- 18790593 and 13688375
- Volume :
- 47
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Oral oncology
- Accession number :
- edsair.doi.dedup.....bcdd9df8ed8e2ad0ac85d84510a9305e