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IRCT20231003059595N1 IRCT 2023-11-11 Mashhad University of Medical Sciences Evaluation the effect of endoscopic medialization thyroplasty using nasal septal cartilage graft on voice features Evaluation the effect of endoscopic medialization thyroplasty using autologous nasal septal cartilage graft in patients with unilateral vocal fold paralysis on voice features: A before and after clinical trial 2023-11-11 anticipated 15 Complete https://irct.ir/trial/73255 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Paralysis of vocal cords and larynx. In operating room conditions and under general anesthesia, after prep and drape in sterile conditions, a hemitransfix incision is made at the mucocutaneous junction to remove the septum. The mucoperichondral flaps are raised bilaterally to expose the quadriangular cartilage. Then, mucoperiosteal flaps are raised on the vomer and maxillary crest to create maximum exposure. A vertical incision is made 1.5 cm posterior to the caudal border of the quadriangular cartilage. Another cartilaginous incision is made parallel to the dorsum, about 1.5 cm below the dorsum. The cartilage of the septum will be removed by disarticulating it from the maxillary crest, vomer and perpendicular plate of the ethmoid bone. In order to prevent damage to the bridge of the nose and create a saddle nose, at least one centimeter of cartilage will be preserved in the dorsal and lower part of the nose. The incision is repaired using Vicryl thread and quilting sutures are placed on both sides of the septum. Nasal pack is performed to maintain the mucoperichondrium to the nasoseptal cartilage and prevent hematoma formation. Then, using direct microlaryngoscopy, vocal folds are observed. After carpool injection, a lateral cordotomy is performed with a medial micro-flap and a pocket is created in the thyroarytenoid muscle complex and vocalis. It will be measured with a ruler from the anterior commissure to the vocal process. Then, according to the obtained size, one or more cartilage strips, measured in length and two to three millimeters in width, are placed separately in the envelope from front to back, so that optimal medialization is achieved based on the transverse and vertical planes of the vocal fold. Then the incision will be sutured with 0.6 Vicryl thread. Once homeostasis is established, the operation will be terminated.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Ehsan Khadivi
Ghaem hospital, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 9176699199 00 51 38400001 khadivie@mums.ac.ir Mashhad University of Medical Sciences scientific Ehsan Khadivi
Ghaem Hospital, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0001 khadivie@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Unilateral vocal fold paralysis Age : above 18y 18 years no limit Both Unwillingness to participate in the study Saddle nose Bilateral vocal fold paralysis History of septoplasty Uncontrolled head and neck malignancy External laryngeal trauma Laryngeal neoplasm Severe laryngeal stenosis Central nervous system disorder Severe cardiopulmonary disorder that the patient cannot tolerate surgery J38. 00 Paralysis of vocal cords and larynx, unspecified Treatment - Surgery In operating room conditions and under general anesthesia, after prep and drape in sterile conditions, a hemitransfix incision is made at the mucocutaneous junction to remove the septum. The mucoperichondral flaps are raised bilaterally to expose the quadriangular cartilage. Then, mucoperiosteal flaps are raised on the vomer and maxillary crest to create maximum exposure. A vertical incision is made 1.5 cm posterior to the caudal border of the quadriangular cartilage. Another cartilaginous incision is made parallel to the dorsum, about 1.5 cm below the dorsum. The cartilage of the septum will be removed by disarticulating it from the maxillary crest, vomer and perpendicular plate of the ethmoid bone. In order to prevent damage to the bridge of the nose and create a saddle nose, at least one centimeter of cartilage will be preserved in the dorsal and lower part of the nose. The incision is repaired using Vicryl thread and quilting sutures are placed on both sides of the septum. Nasal pack is performed to maintain the mucoperichondrium to the nasoseptal cartilage and prevent hematoma formation. Then, using direct microlaryngoscopy, vocal folds are observed. After carpool injection, a lateral cordotomy is performed with a medial micro-flap and a pocket is created in the thyroarytenoid muscle complex and vocalis. It will be measured with a ruler from the anterior commissure to the vocal process. Then, according to the obtained size, one or more cartilage strips, measured in length and two to three millimeters in width, are placed separately in the envelope from front to back, so that optimal medialization is achieved based on the transverse and vertical planes of the vocal fold. Then the incision will be sutured with 0.6 Vicryl thread. Once homeostasis is established, the operation will be terminated. Stridor. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient. Aspiration. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient. Auditory-perceptual characteristics of sound. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: GRBAS scale is used to evaluate audio-perception of sound, which describes Grade, Roughness, Breathiness, Asthenia and Straining in 4 modes (0=no defect, 1=mild defect, 2=moderate defect and 3=severe defect). This index is an expert-oriented index. For this purpose, the voice sample recorded from the patient with the help of headphones for the speech therapist is played according to the mentioned 4-degree scale. Voice handicap index. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Questionnaire will be filled in three functional, physical and emotional parts in these patients. This questionnaire has 30 questions, and it is provided to the patient and completed by them in each of the assessment phases. Acoustic characteristics of sound. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Acoustic evaluations include many things that are evaluated in this research. All acoustic evaluations will be done by a speech therapist with the help of PRAAT software. The types of acoustic features are mentioned below. 1- Maximum vocalization time (MPT): to evaluate the maximum ability of a person. It is measured based on seconds using a stopwatch in three times and the average number of times is recorded. 2- Jitter: disturbance of frequency and amplitude of frequency disturbance 3- Shimmer: disturbance of amplitude of oscillation 4- Noise to harmonic ratio (NHR): to check the sound quality 5- Average fundamental frequency (F0): indicator of the usual pitch 6- Closed quotient: percentage of duration The time of a glottis cycle when the vocal folds are closed and the airflow does not pass. Dyspnea. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Based on patient history and clinical presentation using NYHA criteria. Saddle nose. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient. Septal perforation. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient. Surgical site infection. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient. Chondral graft failure. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient. Mashhad University of Medical Sciences Approved 2023-04-11 Ethics Committee of Mashhad Faculty of Medical Sciences Medicine Faculty, Azadi Sq. Mashhad Razavi Khorasan Iran (Islamic Republic of)