This study enrolls patients requiring transoral pharyngeal surgery for the following conditions: adenoid hypertrophy (manifested as nasal obstruction, mouth breathing, and snoring during sleep)
Conditions
Interventions
Control Group:Intraoperative soft palate suspension using the double-strap method.
Experimental Group:Intraoperative soft palate suspension using the full-wrap method.
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
2 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form; for patients aged <18 years, the informed consent form must be signed by their legal guardian. 2.Age between 2 and 70 years (inclusive), male or female. 3.Patients requiring transoral surgery of the nose, pharynx, parapharyngeal space, or skull base, in which intraoperative soft palate suspension is needed. 4.Intact soft palate mucosa with no ulcers, scars, or other lesions before surgery.
Exclusion criteria
Exclusion criteria: 1.Congenital cleft palate or submucous cleft palate. 2.Patients with limited cervical spine mobility, micrognathia, or other conditions affecting surgical exposure. 3.Pregnant or breastfeeding women. 4.Presence of markedly abnormal laboratory test results, such as significant abnormalities in routine blood tests, blood biochemistry, liver and kidney function, or coagulation function. 5.Patients with active infection or infectious diseases. 6.Severe cardiac insufficiency (NYHA class III-IV). 7.Other conditions deemed unsuitable for surgery after evaluation (e.g., concomitant severe heart, brain, or lung diseases; high anesthetic risk; patients not fit for surgery).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of device-related adverse events;Incidence of soft palate injury; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAE);Postoperative VAS pain score;System Usability Scale (SUS) score;Incidence of complications not related to soft palate injury;Proportion of surgery interruption or early termination;Incidence of postoperative infection or fever;Healing time of soft palate injury; | — |
Countries
China
Contacts
Public ContactChen Mingyuan
Fifth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed