Adenoid Hypertrophy, Nasopharyngeal Diseases, Nasopharyngeal Tumors, Parapharyngeal or Skull Base Lesions, Required Soft Palate Suspension, Tonsillar Hypertrophy
Conditions
Keywords
soft plate injury, Transoral pharyngeal surgery, Soft palate suspension, Randomized controlled trial, Full-wrap suspension
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREIntraoperative soft palate suspension using the double-strap method.
The double-strap suspension method is used intraoperatively. Thin straps are inserted into both nasal cavities, pulled out through the oral cavity, then connected and fixed at both ends to lift the soft palate and ensure adequate exposure of the nasopharynx.
PROCEDUREIntraoperative soft palate suspension using the full-wrap method.
The full-wrap suspension method is used. The fixation string attached to one end of the full-wrap protective sleeve is inserted through the nasal cavity, pulled out through the choanae (posterior nares), and then connected to the main body of the sleeve. The main body is then inserted through the oral cavity, moved into position around the soft palate, adjusted and fixed to suspend the soft palate and expose the nasopharynx.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of soft palate injury | 24 hours postoperatively | Observe the oropharynx (including the condition of the soft palate mucosa) of all patients using an endoscope, and simultaneously take photographs for documentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing time of soft palate injury | 24 hours, 1 week, and 1 month postoperatively | The number of days required for complete healing of soft palate injury observed during follow-up visits. |
| Incidence of complications not related to soft palate injury | 24 hours, 1 week, and 1 month postoperatively | During follow-up, observe, record, and statistically analyze the occurrence of non-soft-palate injuries. |
| System Usability Scale (SUS) score | Within 24 hours postoperatively | Within 24 hours postoperatively, the attending physician or higher-ranked surgeon who has received uniform training will independently complete the System Usability Scale (SUS) based on their actual intraoperative experience with the full-wrap suspension or double-strap suspension. Each surgeon evaluates only the suspension method they personally performed, and anonymity is used to ensure objectivity and authenticity of the scores. The System Usability Scale generates a score from 0 to 100, with higher scores indicating better usability. |
| Postoperative VAS pain score | 24 hours, 1 week, and 1 month postoperatively | A 10 cm (100 mm) sliding scale is used, with "0" (no pain) at one end and "10" (the worst possible pain) at the other end. The patient is instructed to mark on the scale the position that best represents their current pain level according to their subjective feeling, and the physician reads and records the corresponding score (0-10). Based on the score, the pain level is categorized as: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. |
Countries
China
Contacts
CONTACTWenbin Wu, PhD candidate
Outcome results
None listed