NCT06983860

Brief Summary

Low temperature plasma radiofofency ablation of tonsil under 70° nasal endoscope can directly view the lesion area on the monitor, clearly enlarge the operating field, and has the advantages of small surgical trauma, good hemostatic effect, light postoperative pain, low probability of postoperative bleeding and quick postoperative recovery of patients, etc. It is a good surgical mode integrating surgery and teaching, and has brought great benefits to patients, and is worth promoting and applying.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

April 16, 2025

Last Update Submit

May 14, 2025

Conditions

Keywords

endoscope-assistedlow-temperature plasmaradiofrequency ablation resectiontonsils

Outcome Measures

Primary Outcomes (3)

  • Perioperative indexes

    operation time, intraoperative blood loss, length of hospital stay

    intraoperative

  • Visual Analogue Scale (VAS)

    VAS score is a widely used subjective assessment method for pain assessment. Using a walking scale about 10cm long, one side is marked with 10 scales, and the two ends are respectively "0" and "10". 0 indicates no pain, and 10 indicates unbearable pain. The patient is asked to mark the pain value and record it.

    VAS score was performed at 6h, 12h, 24h and 72h after surgery

  • Endoscopic examination

    the formation and shedding of tonsillar fossa in the operative area were observed through the mouth under a 70-degree nasal endoscope; Whether there is bleeding or bleeding in the operative area; The recovery of the operative area and the presence or absence of granulation tissue hyperplasia

    On the 2nd, 4th, 2nd and 4th postoperative days

Secondary Outcomes (2)

  • Postoperative bleeding

    Within 1 month after surgery

  • The occurrence of complications was recorded.

    Within 1 month after surgery

Study Arms (1)

endoscope-assisted low-temperature plasma radiofrequency ablation resection of tonsils

EXPERIMENTAL

In this prospective study, 100 patients admitted to our hospital for tonsillectomy from January 2025 to December 2025 will be recruited as experimental subjects. Perioperative indexes (operation time, intraoperative blood loss, length of hospital stay) were recorded. Visual Analogue Scale (VAS) was used: VAS scores were performed at 6h, 12h, 24h and 72h after surgery. Endoscopic examination: On the 2nd, 4th, 2nd and 4th postoperative days, the formation and shedding of tonsillar fossa were observed through the mouth under a 70-degree nasal endoscope. Whether there is bleeding or bleeding in the operative area; The recovery of the operative area and the presence or absence of granulation tissue hyperplasia. Postoperative bleeding and complications were recorded.

Procedure: Application and demonstration of endoscope-assisted low-temperature plasma radiofrequency ablation resection of tonsils

Interventions

Low temperature plasma radiofofency ablation of tonsil under 70° nasal endoscope can directly view the lesion area on the monitor, clearly enlarge the operating field, and has the advantages of small surgical trauma, good hemostatic effect, light postoperative pain, low probability of postoperative bleeding and quick postoperative recovery of patients, etc. It is a good surgical mode integrating surgery and teaching, and has brought great benefits to patients, and is worth promoting and applying.

endoscope-assisted low-temperature plasma radiofrequency ablation resection of tonsils

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • History of recurrent acute attacks of chronic tonsillitis, with the number of attacks \>3 times per year for more than 2 years;
  • accompanied by snoring, choking and apnea during night sleep;
  • Age 3-65 years old, gender is not limited;
  • No major systemic diseases, such as cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, hematopoietic system diseases;
  • Subjects who can understand and abide by the research procedures and voluntarily participate in the experiment by signing the informed consent form (the informed consent is signed by themselves or their legal representatives).

You may not qualify if:

  • cardiopulmonary insufficiency;
  • Patients with systemic blood diseases;
  • Patients with acute and chronic bronchial or lung infections;
  • Complicated with severe cardiovascular system disease or hepatic and renal insufficiency;
  • \) Patients with mental abnormalities or who do not cooperate with treatment 7) Researchers who are participating in other trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jun G Tang, Dr

    principal

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The prospective study method was adopted, and 100 patients who were admitted to the ward of our hospital for tonsillectomy from January 2025 to December 2025 were recruited as experimental subjects. 1.1 Main evaluation indicators 1. Perioperative indexes (operation time, intraoperative blood loss, length of hospital stay) were recorded. 2. Visual Analogue Scale (VAS): VAS score was performed at 6h, 12h, 24h and 72h after surgery. 3. Endoscopic examination: On the 2nd, 4th, 2nd and 4th postoperative days, the formation and shedding of tonsillar fossa in the operative area were observed through the mouth under a 70-degree nasal endoscope; Whether there is bleeding or bleeding in the operative area; The recovery of the operative area and the presence or absence of granulation tissue hyperplasia. 1.2 Secondary evaluation indicators 1. Postoperative bleeding: Observe and record postoperative bleeding, and calculate the bleeding rate. 2. The occurrence of complications was recorded.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 21, 2025

Study Start

July 1, 2025

Primary Completion

December 30, 2025

Study Completion

March 31, 2026

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The data will be published online as a paper

Shared Documents
STUDY PROTOCOL
Time Frame
December 2025 to December 2026
Access Criteria
The data and content of my published study can be accessed by email or downloaded online