Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome
Primary Purpose
Obstructive Sleep Apnea
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Barbed Suture Modified Anterior Palatoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Barbed suture, Anterior palatoplasty
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.
Sites / Locations
- Benha University Hospital, Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified Anterior Palatoplasty
Arm Description
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
Outcomes
Primary Outcome Measures
Apnea Hypopnea index
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04572503
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, Barbed suture, Anterior palatoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified Anterior Palatoplasty
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Barbed Suture Modified Anterior Palatoplasty
Intervention Description
Barbed Suture Modified Anterior Palatoplasty using single resorbable polydioxanone barbed bidirectional size 0 monofilament suture
Primary Outcome Measure Information:
Title
Apnea Hypopnea index
Description
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelrahman A Abdelalim, MD
Phone
0201069372609
Email
aborazan2009@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrahman A Abdelalim, MD
Organizational Affiliation
Benha Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed A Elsayed, MD
Organizational Affiliation
Benha Faculty of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hesham A Abdelsamea, MD
Organizational Affiliation
Benha Faculty of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Y Abdelsalam, Resident
Organizational Affiliation
Al-Agouza specialized hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Benha University Hospital, Faculty of Medicine
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13512
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelrahman A Abdelalim, MD
Phone
0201069372609
Email
aborazan2009@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29045003
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.
Results Reference
background
PubMed Identifier
25762837
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.
Results Reference
background
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Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome
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