Clinical trial NCT04572503: Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome
Official title: Barbed Suture Modified Anterior Palatoplasty In Management of Mild and Moderate Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Barbed suture
Anterior palatoplasty
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Apnea Hypopnea index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital, Faculty of Medicine
state: Qalubia
Study officials:
affiliation: Benha University
name: Abdelrahman A Abdelalim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Mohamed A Elsayed, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Hesham A Abdelsamea, MD
role: STUDY_CHAIR
affiliation: Al-Agouza specialized hospital
name: Ahmed Y Abdelsalam, Resident
role: STUDY_CHAIR
References:
citation: 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.
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.