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Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04572503
Enrollment
20
Registered
2020-10-01
Start date
2020-10-07
Completion date
2026-03-01
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Barbed suture, Anterior palatoplasty

Brief 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).

Detailed 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.

Interventions

PROCEDUREBarbed Suture Modified Anterior Palatoplasty

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

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Apnea Hypopnea index6 monthsone-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)

Countries

Egypt

Contacts

Primary ContactAbdelrahman A Abdelalim, MD
aborazan2009@gmail.com0201069372609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026