Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome

NCT ID: NCT04572503

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2026-03-01

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified Anterior Palatoplasty

Barbed Suture Modified Anterior Palatoplasty In Management of Mild and Moderate Obstructive Sleep Apnea Syndromea using single resorbable polydioxanone barbed bidirectional size 0 monofilament suture

Group Type: EXPERIMENTAL

Barbed Suture Modified Anterior Palatoplasty

Intervention Type: PROCEDURE

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

Interventions

Barbed Suture Modified Anterior Palatoplasty

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Ahmed Abdelalim

MD Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelrahman A Abdelalim, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Mohamed A Elsayed, MD

Role: STUDY_CHAIR

Benha University

Hesham A Abdelsamea, MD

Role: STUDY_CHAIR

Benha University

Ahmed Y Abdelsalam, Resident

Role: STUDY_CHAIR

Al-Agouza specialized hospital

Locations

Benha University Hospital, Faculty of Medicine

Banhā, Qalyubia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abdelrahman A Abdelalim, MD

Role: CONTACT

aborazan2009@gmail.com

0201069372609

Facility Contacts

Abdelrahman A Abdelalim, MD

Role: primary

aborazan2009@gmail.com

0201069372609

References

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.

Reference Type: BACKGROUND

PMID: 29045003 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25762837 (View on PubMed)

Other Identifiers

MS 19-2-2020

Identifier Type: -

Identifier Source: org_study_id