Clinical trial · Interventional
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
NCT07552545CI-TRIAL-00117566not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoid Hypertrophy | — | UNRESOLVED | — |
| Nasopharyngeal Diseases | — | UNRESOLVED | — |
| Nasopharyngeal Tumors | Nasopharyngeal Neoplasm | ALIAS | 0.90 |
| Parapharyngeal or Skull Base Lesions | — | UNRESOLVED | — |
| Required Soft Palate Suspension | — | UNRESOLVED | — |
| Tonsillar Hypertrophy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative soft palate suspension using the double-strap method. | Procedure | — | UNRESOLVED |
| Intraoperative soft palate suspension using the full-wrap method. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- 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.
- interventionNames
- Procedure: Intraoperative soft palate suspension using the double-strap method.
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- 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.
- interventionNames
- Procedure: Intraoperative soft palate suspension using the full-wrap method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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).
References
Publications (8)
- RESULTKim 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. PMID 38498353
- RESULTMilczuk 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. PMID 22929115
- RESULTRobison 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. PMID 21422312
- RESULTRoss 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. PMID 12646834
- RESULTGallagher 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. PMID 20493363
- RESULTPeghini 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. PMID 11375603
- RESULTAllencherril 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. PMID 27871543
- RESULTWang 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.