1. 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
- Author
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Harms, Kim, Post, Wendy J., van de Laan, Klaas T., van den Hoogen, Frank J. A., Eerenstein, Simone E. J., van der Laan, Bernard F. A. M., Erenstein, S.E., Otolaryngology / Head & Neck Surgery, CCA - Quality of life, Nieuwenhuis Institute (Pedagogical and Educational Sciences), Faculteit Medische Wetenschappen/UMCG, Damage and Repair in Cancer Development and Cancer Treatment (DARE), and Man, Biomaterials and Microbes (MBM)
- 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 - 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
- Published
- 2011