TriangleNCT04458818 · OUTCOME
Change in Mean Phonation Time
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- seconds
- Interval / dispersion
- Standard Deviation
- Time frame
- Preoperative and 14th Postoperative day
What was measured
Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.
Groups in this outcome
Prolene Mesh Implant
The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization. Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.
| Group | Source count |
|---|---|
| Prolene Mesh Implant | 39 |
Reported measurements
pre operative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Prolene Mesh Implant | 7.74 | 1.712 | Not reported | Not reported | Not reported |
post operative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Prolene Mesh Implant | 14.08 | 3.390 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.712
- value
- 7.74
- title
- pre operative
- categories
- measurements
- group Id
- OG000
- spread
- 3.390
- value
- 14.08
- title
- post operative
- denoms
- counts
- group Id
- OG000
- value
- 39
- units
- Participants
- description
- Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.
- dispersion Type
- Standard Deviation
- groups
- description
- The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization. Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.
- id
- OG000
- title
- Prolene Mesh Implant
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Preoperative and 14th Postoperative day
- title
- Change in Mean Phonation Time
- type
- PRIMARY
- unit Of Measure
- seconds
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice