Tonsillectomy and Expansion Sphincter Pharyngoplasty Operations

NCT06119841 | Completed

• 1 other identifier: SDoluoglu
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Background: To compare the efficacy of tonsillectomy and expansion sphincter pharyngoplasty (ESP) in the surgical treatment of obstructive sleep apnea (OSA). Methods: Patients with Friedman grade III-IV tonsil hypertrophy and OSA diagnosed with polysomnography were separated into two groups according to the surgery performed, as the classic tonsillectomy group (Group 1) and the ESP group (Group 2). The primary endpoint of the study was to determine the Apnea-Hypopnea Index (AHI) value. The preoperative and postoperative AHI scores and the decreases in these scores were noted. The change in AHI was calculated as a percentage (preoperative AHI - postoperative AHI/ preoperative AHI x 100) and the two groups were compared. An AHI value of \<10 events/hour was accepted as cure.

Conditions

Obstructive Sleep Apnea; Osa Syndrome

Keywords

Apnea-Hypopnea Index; Expansion sphincter pharyngoplasty; Obstructive sleep apnea; Tonsillectomy; Upper airway surgery

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  The patients were separated into 3 subgroups according to the severity of OSA determined in the PSG recording: mild (AHI ≥ 10 and \<15 events/hr), moderate (AHI ≥15 and \<30 events/hr), and severe (AHI ≥ 30 events/hr). The preoperative and postoperative AHI scores and the decreases in these scores were noted. The change in AHI was calculated as a percentage (preoperative AHI - postoperative AHI/ preoperative AHI x 100) and the two groups were compared. An AHI value of \<10 events/hr was accepted as cure. Success was considered as postoperative AHI \<20 events/hr or a 50% reduction in the preoperative AHI.

  1 hour

Study Arms (2)

Tonsillectomy

EXPERIMENTAL

Tonsillectomy was performed with cold dissection including the whole tonsil and capsule, and bleeding was controlled with bipolar cauterisation.

Procedure: Tonsillectomy

Expansion sphincter pharyngoplasty

EXPERIMENTAL

In the ESP technique, following bilateral tonsillectomy with cold dissection and bleeding control with bipolar cauterisation, the palatopharyngeus muscle was identified and a superior-based muscle flap was formed by cutting the upper two-thirds of the muscle on both sides from the lower third attachment site. By opening tunnels to the anterior plica mucosa, the dissected palatopharyngeus muscle was placed in these tunnels, and was sutured to the pterygomandibular raphe with vicryl 2-0 sutures. The mucosal cuts were closed with vicryl 3-0 sutures

Procedure: Expansion sphincter pharyngoplasty

Interventions

Tonsillectomy PROCEDURE

Tonsillectomy was performed with cold dissection including the whole tonsil and capsule, and bleeding was controlled with bipolar cauterisation.

Tonsillectomy

Expansion sphincter pharyngoplasty PROCEDURE

In the ESP technique, following bilateral tonsillectomy with cold dissection and bleeding control with bipolar cauterisation, the palatopharyngeus muscle was identified and a superior-based muscle flap was formed by cutting the upper two-thirds of the muscle on both sides from the lower third attachment site. By opening tunnels to the anterior plica mucosa, the dissected palatopharyngeus muscle was placed in these tunnels, and was sutured to the pterygomandibular raphe with vicryl 2-0 sutures. The mucosal cuts were closed with vicryl 3-0 sutures

Expansion sphincter pharyngoplasty

Eligibility Criteria

• Age: 27 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients aged \>27 years
• Apnea-Hypopnea Index (AHI) value of ≥10.

You may not qualify if:

• absent preoperative and/or postoperative PSG
• craniofacial anomaly such as evident retrognathia
• severe cardiac, respiratory, or neurological disease
• an evident obstruction at the tongue base level in the endoscopic examination

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Carnevale syndrome

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Gokhan Toptas, MD

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 7, 2023
• Study Start: January 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)