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Tonsillectomy and Expansion Sphincter Pharyngoplasty Operations

NCT06119841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-02-21

No results posted yet for this study

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

Interventions

PROCEDURE

Tonsillectomy

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

PROCEDURE

Expansion sphincter pharyngoplasty

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

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Principal Investigators

  • Gokhan Toptas, MD · Saglik Bilimleri Universitesi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
27 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119841 on ClinicalTrials.gov