Trial Outcomes & Findings for A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study. (NCT NCT04458818)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

Preoperative and 14th Postoperative day

Results posted on

2021-04-29

Participant Flow

01 May 2020 - 30 Jan 2021

Before inducting into the study, patients were tested with exclusion criteria i.e Neoplasia, trauma and muscular dystrophy cases, and inclusion criteria i.e.15 years and younger, vocal cord paralysis and voice disability.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prolene Mesh Implant n=39 Participants 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.
Age, Categorical <=18 years	1 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=39 Participants
Age, Categorical >=65 years	6 Participants n=39 Participants
Sex: Female, Male Female	24 Participants n=39 Participants
Sex: Female, Male Male	15 Participants n=39 Participants
Region of Enrollment Pakistan	39 Participants n=39 Participants

PRIMARY outcome

Timeframe: Preoperative and 14th Postoperative day

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.

Outcome measures

Outcome measures
Measure	Prolene Mesh Implant n=39 Participants 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.
Change in Mean Phonation Time pre operative	7.74 seconds Standard Deviation 1.712
Change in Mean Phonation Time post operative	14.08 seconds Standard Deviation 3.390

PRIMARY outcome

Timeframe: Preoperative and 14th Postoperative day

Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.

Outcome measures

Outcome measures
Measure	Prolene Mesh Implant n=39 Participants 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.
Change in Maximum Words Count pre operative	11.33 words Standard Deviation 3.359
Change in Maximum Words Count post operative	18.28 words Standard Deviation 5.047

PRIMARY outcome

Timeframe: Preoperative and 14th Postoperative day

For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. Score 1 will be the score for lowest and 10 being the best score for voice quality.

Outcome measures

Outcome measures
Measure	Prolene Mesh Implant n=39 Participants 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.
Change in Voice Quality on Visual Analogue Score pre operative	4.77 score on a scale Standard Deviation 1.224
Change in Voice Quality on Visual Analogue Score post operative	7.64 score on a scale Standard Deviation 1.308

Adverse Events

Prolene Mesh Implant

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prolene Mesh Implant n=39 participants at risk 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.
Respiratory, thoracic and mediastinal disorders URTI	10.3% 4/39 • Number of events 39 • 1 year follow up was kept for all the patients.
Infections and infestations skin infection	2.6% 1/39 • Number of events 39 • 1 year follow up was kept for all the patients.

Additional Information

Dr Muhammad Noman Karim

Combined Military Hospital Kharian, Punjab Pakistan

Phone: +923313358884

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place