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

May 5, 2026 updated by: Ming-Yuan Chen, Sun Yat-sen University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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.
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.
Experimental: Experimental Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of soft palate injury
Time Frame: 24 hours postoperatively
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing time of soft palate injury
Time Frame: 24 hours, 1 week, and 1 month postoperatively
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
Time Frame: 24 hours, 1 week, and 1 month postoperatively
During follow-up, observe, record, and statistically analyze the occurrence of non-soft-palate injuries.
24 hours, 1 week, and 1 month postoperatively
Postoperative VAS pain score
Time Frame: 24 hours, 1 week, and 1 month postoperatively
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
System Usability Scale (SUS) score
Time Frame: Within 24 hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDWY.BYAFZZX.051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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