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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
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.
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.
Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Incidence of soft palate injury
Observe the oropharynx (including the condition of the soft palate mucosa) of all patients using an endoscope, and simultaneously take photographs for documentation.
Time frame: 24 hours postoperatively
Healing time of soft palate injury
The number of days required for complete healing of soft palate injury observed during follow-up visits.
Time frame: 24 hours, 1 week, and 1 month postoperatively
Incidence of complications not related to soft palate injury
During follow-up, observe, record, and statistically analyze the occurrence of non-soft-palate injuries.
Time frame: 24 hours, 1 week, and 1 month postoperatively
System Usability Scale (SUS) score
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.
Time frame: Within 24 hours postoperatively
Postoperative VAS pain score
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.
Time frame: 24 hours, 1 week, and 1 month postoperatively
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