Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Obstructive Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04572503
Collaborators
Not Provided
Investigators
Principal Investigator: Abdelrahman A Abdelalim, MD Benha Faculty of Medicine Study Chair: Mohamed A Elsayed, MD Benha Faculty of Medicine Study Chair: Hesham A Abdelsamea, MD Benha Faculty of Medicine Study Chair: Ahmed Y Abdelsalam, Resident Al-Agouza specialized hospital