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NCT Number: NCT04572503

Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital, Faculty of Medicine

Banhā, Qalyubia Governorate, 13512, Egypt

Location status: Recruiting

Location contact

Abdelrahman A Abdelalim, MD

CONTACT

[email protected]

0201069372609

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Barbed Suture Modified Anterior Palatoplasty

Procedure

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

Primary outcomes

  1. Apnea Hypopnea index

    Time frame: 6 months

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman A Abdelalim, MD

CONTACT

[email protected]

0201069372609

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Oct 1, 2020
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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