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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-70
SponsorSun Yat-sen University

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intraoperative soft palate suspension using the double-strap method.
  • Intraoperative soft palate suspension using the full-wrap method.

Treatment groups

138 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Sponsor institution