Full-wrap Suspension versus Double-Strap Suspension for Reducing the Incidence of Soft Palate Injury: A Prospective Multi-center Randomized Controlled Trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Control Group:Intraoperative soft palate suspension using the double‐strap method.;Experimental Group:Intraoperative soft palate suspension using the full‐wrap method.; CONDITION: This study enrolls patients requiring transoral pharyngeal surgery for the following conditions: adenoid hypertrophy (manifested as nasal obstruction, mouth breathing, and snoring during sleep); tonsillar hypertrophy (manifested as pharyngeal foreign body sensation, recurrent sore throat, and dysphagia); nasopharyngeal tumor (manifested as epistaxis, nasal obstruction, aural fullness, and cervical PRIMARY OUTCOME: Incidence of device‐related adverse events;Incidence of soft palate injury; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: 28d8bae8fa1c5f2253d89b1a537a57267cecd450
First added on: Jul 21, 2026