AzTrials
AzTrials

Adenoid HypertrophyNCT07552545

Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery

A study testing Intraoperative soft palate suspension using the double-strap method. and Intraoperative soft palate suspension using the full-wrap method. in people with Adenoid Hypertrophy and Tonsillar Hypertrophy, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 70 years
What is being tested?
Intraoperative soft palate suspension using the double-strap method. and Intraoperative soft palate suspension using the full-wrap method.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteChina
Study dates
30 Sep 2026to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenbin Wu, PhD candidate contact

+8618829523273

wuwb33@mail2.sysu.edu.cn

China1 site

  • Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Ming-Yuan Chen, PhD., 86-13903052650, chmingy@mail.sysu.edu.cn

Other trials in China

About this study

Official title: Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery: A Prospective Randomized Controlled Trial

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.

Read the 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.

Being tested
Intraoperative soft palate suspension using the double-strap method., Intraoperative soft palate suspension using the full-wrap method.
Keywords
soft plate injury, Transoral pharyngeal surgery, Soft palate suspension, Randomized controlled trial, Full-wrap suspension
Medical subject headings
Nasopharyngeal Diseases, Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoperative soft palate suspension using the double-strap method.Procedure or surgery

    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.

  • Intraoperative soft palate suspension using the full-wrap method.Procedure or surgery

    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.

Study groups in NCT07552545
Study groupRoleWhat they receive
Control GroupActive comparatorIn 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.
Receives: Procedure: Intraoperative soft palate suspension using the double-strap method.
Experimental GroupExperimentalIn 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.
Receives: Procedure: Intraoperative soft palate suspension using the full-wrap method.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours postoperatively

Secondary outcomes (4)

  1. Healing time of soft palate injury

    The number of days required for complete healing of soft palate injury observed during follow-up visits.

    Measured: 24 hours, 1 week, and 1 month postoperatively

  2. Incidence of complications not related to soft palate injury

    During follow-up, observe, record, and statistically analyze the occurrence of non-soft-palate injuries.

    Measured: 24 hours, 1 week, and 1 month postoperatively

  3. 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.

    Measured: Within 24 hours postoperatively

  4. 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.

    Measured: 24 hours, 1 week, and 1 month postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07552545
Sponsor's protocol ID
ZDWY.BYAFZZX.051
Status last verified
Jul 2026
First submitted
20 Apr 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38498353

  • 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.

    PubMed 22929115

  • 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.

    PubMed 21422312

  • 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.

    PubMed 12646834

  • 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.

    PubMed 20493363

  • 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.

    PubMed 11375603

  • 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.

    PubMed 27871543

  • 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.

    PubMed 39476644

Questions about this trial

What is this clinical trial studying?

A study testing Intraoperative soft palate suspension using the double-strap method. and Intraoperative soft palate suspension using the full-wrap method. in people with Adenoid Hypertrophy and Tonsillar Hypertrophy, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenbin Wu, PhD candidate (+8618829523273, wuwb33@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of soft palate injury (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07552545, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in