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

Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery: A Prospective Randomized Controlled Trial

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.

This study is a prospective, parallel-group, multicenter clinical study. A total of 138 subjects will be enrolled, including 69 in the control group (using double-strap suspension) and 69 in the experimental group (using full-wrap suspension). By comparing the incidence of soft palate injury, postoperative pain score (VAS), healing time of soft palate injury, incidence of non-soft-palate complications, and System Usability Scale (SUS) score between the two groups, the study aims to investigate whether the use of full-wrap suspension can effectively reduce soft palate injury caused by intraoperative manipulation.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).