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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | In the control group, 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. |
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| Experimental Group | Experimental | In the experimental group, 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative soft palate suspension using the double-strap method. | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Healing time of soft palate injury | The number of days required for complete healing of soft palate injury observed during follow-up visits. | 24 hours, 1 week, and 1 month postoperatively |
| Incidence of complications not related to soft palate injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbin Wu, PhD candidate | Contact | +8618829523273 | wuwb33@mail2.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fifth Affiliated Hospital of Sun Yat-sen University | Zhuhai | Guangdong | 519000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38498353 | Result | Kim W, Yu HW, Kim SJ, Chai YJ, Choi JY, Lee KE. The anterior neck scar outcomes of conventional thyroidectomy using a wound protector: a multicenter double-blinded randomized controlled trial. Int J Surg. 2024 Jun 1;110(6):3425-3432. doi: 10.1097/JS9.0000000000001288. | |
| 22929115 | Result | Milczuk HA. Effects of oropharyngeal surgery on velopharyngeal competence. Curr Opin Otolaryngol Head Neck Surg. 2012 Dec;20(6):522-6. doi: 10.1097/MOO.0b013e32835873cc. |
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Applicants may reguest sharing of raw data from March 1,2025 onwards to the project contacts email address (chmingy@mail.sysu.edu.cn) if justified.
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|
| Intraoperative soft palate suspension using the full-wrap method. | Procedure | 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. |
|
During follow-up, observe, record, and statistically analyze the occurrence of non-soft-palate injuries.
| 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. | 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. | 24 hours, 1 week, and 1 month postoperatively |
| 21422312 | Result | Robison JG, Otteson TD. Increased prevalence of obstructive sleep apnea in patients with cleft palate. Arch Otolaryngol Head Neck Surg. 2011 Mar;137(3):269-74. doi: 10.1001/archoto.2011.8. |
| 12646834 | Result | Ross AT, Kazahaya K, Tom LW. Revisiting outpatient tonsillectomy in young children. Otolaryngol Head Neck Surg. 2003 Mar;128(3):326-31. doi: 10.1067/mhn.2003.60. |
| 20493363 | Result | Gallagher TQ, Wilcox L, McGuire E, Derkay CS. Analyzing factors associated with major complications after adenotonsillectomy in 4776 patients: comparing three tonsillectomy techniques. Otolaryngol Head Neck Surg. 2010 Jun;142(6):886-92. doi: 10.1016/j.otohns.2010.02.019. |
| 11375603 | Result | Peghini PL, Salcedo JA, Al-Kawas FH. Traumatic uvulitis: a rare complication of upper GI endoscopy. Gastrointest Endosc. 2001 Jun;53(7):818-20. doi: 10.1067/mge.2001.114953. No abstract available. |
| 27871543 | Result | Allencherril JP, Joseph L. Soft palate trauma induced during GlideScope intubation. J Clin Anesth. 2016 Dec;35:278-280. doi: 10.1016/j.jclinane.2016.08.011. Epub 2016 Oct 10. |
| 39476644 | Result | Wang L, Ji K, Tu J. Comparative outcomes of microdebrider adenoidectomy, curettage adenoidectomy through oral cavity under 70 endoscope, and endoscopic transoral low-temperature ablation for adenoid hypertrophy. Int J Pediatr Otorhinolaryngol. 2024 Nov;186:112143. doi: 10.1016/j.ijporl.2024.112143. Epub 2024 Oct 20. |
| ID | Term |
|---|---|
| D009302 | Nasopharyngeal Diseases |
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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