Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery

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Conditions studied: Adenoid Hypertrophy, Tonsillar Hypertrophy, Nasopharyngeal Diseases, Nasopharyngeal Tumors, Parapharyngeal or Skull Base Lesions, Required Soft Palate Suspension

In brief

This study aims to evaluate whether the use of full-wrap suspension, compared with the traditional double-strap suspension, can effectively reduce the risk of intraoperative and postoperative soft palate injury in transoral/transnasal pharyngeal surgery. Through a prospective, multicenter, randomized controlled design, this study will provide evidence-based support for the clinical promotion and standardized application of full-wrap suspension.

Key facts

Study ID

NCT07552545

Run by

Sun Yat-sen University

People needed

138

Starts

2026-09-30

Expected to finish

2027-10-31

Last updated by the study team

2026-07-10

Who can join

Age: 2 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily sign the informed consent form; for patients aged <18 years, the informed consent form must be signed by their legal guardian.
• Age between 2 and 70 years (inclusive), male or female.
• Patients requiring transoral surgery of the nose, pharynx, parapharyngeal space, or skull base, in which intraoperative soft palate suspension is needed.
• Intact soft palate mucosa with no ulcers, scars, or other lesions before surgery.

You may not qualify if…

• Congenital cleft palate or submucous cleft palate.
• Patients with limited cervical spine mobility, micrognathia, or other conditions affecting surgical exposure.
• Pregnant or breastfeeding women.
• Presence of markedly abnormal laboratory test results, such as significant abnormalities in routine blood tests, blood biochemistry, liver and kidney function, or coagulation function.
• Patients with active infection or infectious diseases.
• Severe cardiac insufficiency (NYHA class III-IV).
• 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).

Where it is running

• Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China

Full record on ClinicalTrials.gov

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