Full-wrap Suspension Versus Double-Strap Suspension for Reducing the Incidence of Soft Palate Injury: A Prospective Multi-center Randomized Controlled Trial

NCT07552545 | Not Yet Recruiting DMC

• 1 other identifier: ZDWY.BYAFZZX.051
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillar Hypertrophy; Nasopharyngeal Diseases; Nasopharyngeal Tumors; Required Soft Palate Suspension; Adenoid Hypertrophy; Parapharyngeal or Skull Base Lesions

Keywords

soft plate injury; Transoral pharyngeal surgery; Soft palate suspension; Randomized controlled trial; Full-wrap suspension

Outcome Measures

Primary Outcomes (1)

• 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, 1 week, and 1 month postoperatively

Secondary Outcomes (4)

• Healing time of soft palate injury

  24 hours, 1 week, and 1 month postoperatively

• Incidence of complications not related to soft palate injury

  24 hours, 1 week, and 1 month postoperatively

• System Usability Scale (SUS) score

  Within 24 hours postoperatively

• Postoperative VAS pain score

  24 hours, 1 week, and 1 month postoperatively

Study Arms (2)

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.

Procedure: Intraoperative soft palate suspension using the double-strap method.

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.

Procedure: Intraoperative soft palate suspension using the full-wrap method.

Interventions

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.

Control Group

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.

Experimental Group

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

Location

Related Publications (8)

• 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.

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• 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.

  PMID: 22929115 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.

  PMID: 21422312 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.

  PMID: 12646834 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.

  PMID: 20493363 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.

  PMID: 11375603 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.

  PMID: 27871543 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.

  PMID: 39476644 RESULT

MeSH Terms

Conditions

Nasopharyngeal Diseases; Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Wenbin Wu, PhD candidate

CONTACT

+8618829523273; wuwb33@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief physician

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)