Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome

Obstructive Sleep Apnea Clinical Trial

Official title:

Barbed Suture Modified Anterior Palatoplasty In Management of Mild and Moderate Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04572503
• Other study ID #: MS 19-2-2020
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2023
• Source: Benha University
• Contact: Abdelrahman A Abdelalim, MD
• Phone: 0201069372609
• Email: aborazan2009[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness of barbed suture modification of anterior palatoplasty in the treatment of patients with retropalatal mild to moderate obstructive sleep apnea syndrome (OSAS).

Description:

A prospective analytic study will be conducted on a total number of 20 patients presented with mild to moderate obstructive sleep apnea for whom Barbed suture modified anterior palatoplasty will be performed. Surgical Steps - Procedure will be performed under general anesthesia - Bilateral tonsillectomy will be performed. - Then, the inferior portion between upper 2/3 and inferior 1/3 of palatopharyngeus muscle will be partially released - Then, a rectangular shaped strip of mucosa and the underlying submucosa will be removed at the center of the soft palate consisting of 0.5-0.7 mm in length and with width corresponding to the tonsillar fossae distance. - Then,the stripped area will be sutured by single resorbable polydioxanone barbed bidirectional size 0 monofilament suture by introducing one needle at the center point of the wound then will be passed laterally within the palate, turning around pterygomandibular raphe till it comes out at the most superior part of the raphe at one side the thread will be pulled until it hangs at the central transition zone which is a free zone present between the two directions of the thread. - Then, again the needle will be passed back through the tonsillectomy bed and then this suture will be suspended around the raphe again; a gentle traction is then applied on the thread only and no knots are taken.T - The opposite side will be done by the same way. - Finally, each thread will be come out at the raphe of the same side, for locking of the stitches and looseness prevention; a superficial stitch in the opposite direction is taken, and then the thread is cut while bushing the tissue downward for more traction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with mild to moderate obstructive sleep apnea syndrome.
• Patients diagnosed with mild (AHI 5 to15) and moderate (AHI 16 to 30) OSAS with only retropalatal collapses
• Patients who are noncompliant with Continuous positive airway pressure (CPAP).

Exclusion Criteria:

• Patients diagnosed with sever OSAS (AHI more than 30)
• The main site of obstruction at retrolingual level or multilevel obstruction.
• Contraindication of surgery (e.g. cardiovascular problems and bleeding tendency).
• Patients with significant craniofacial anomalies affecting airway.
• Patients with BMI>40 kg/m2.
• Patients unfit for general anesthesia.
• History of previous velopharyngeal or lingual surgeries.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Barbed Suture Modified Anterior Palatoplasty
Barbed Suture Modified Anterior Palatoplasty using single resorbable polydioxanone barbed bidirectional size 0 monofilament suture

Locations

Country	Name	City	State
Egypt	Benha University Hospital, Faculty of Medicine	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Pianta L, Bertazzoni G, Morello R, Perotti P, Nicolai P. Barbed expansion sphincter pharyngoplasty for the treatment of oropharyngeal collapse in obstructive sleep apnoea syndrome: A retrospective study on 17 patients. Clin Otolaryngol. 2018 Apr;43(2):696-700. doi: 10.1111/coa.13008. Epub 2017 Nov 6. No abstract available. — View Citation

Salamanca F, Costantini F, Mantovani M, Bianchi A, Amaina T, Colombo E, Zibordi F. Barbed anterior pharyngoplasty: an evolution of anterior palatoplasty. Acta Otorhinolaryngol Ital. 2014 Dec;34(6):434-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea index	one-night polysomnographic study at sleep lab. The apnea-hypopnea index denotes the total numbers of apnea plus hypopnea events divided by total sleep time in hours (0-5/ hr sleep = mild, 6-15/hr sleep = moderate, more than 15/hr sleep = severe)	6 months