NCT05206799

Brief Summary

To obtain hemorrhage rate after coblation tonsillectomy, and to investigate risk factors of hemorrhage after coblation tonsillectomy in children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

November 15, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 12, 2022

Last Update Submit

November 10, 2022

Conditions

TonsillectomyChildPostoperative Hemorrhage

Keywords

TonsillectomychildPostoperative Hemorrhagelow-temperature plasma radiofrequency ablation

Outcome Measures

Primary Outcomes (2)

  • hemorrhage rate after coblation tonsillectomy

    hemorrhage rate after coblation tonsillectomy in children within 3 weeks

    3 weeks after surgery

  • risk factors of hemorrhage after coblation tonsillectomy

    risk factors of hemorrhage after coblation tonsillectomy in children

    3 weeks after surgery

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Enrolled patiens are children who underwent coblation tonsillectomy from multi-centers in different provinces of China.

You may qualify if:

  • under 18 years old;
  • Clear indications for tonsill surgery;
  • No clear contraindications for tonsill surgery;
  • Parents of the children patients accept surgical treatment;
  • Parents of the children patients able to cooperate with the visit and follow-up.

You may not qualify if:

  • Children patients with a history of adenoid or tonsillectomy surgery;
  • Associated with refractory bleeding diseases;
  • Combined with cleft palate;
  • Down syndrome, Prader-Willi syndrome (PWS) or other chromosomal abnormalities;
  • Neuromuscular diseases (including cerebral palsy);
  • Other diseases that affect physical health, such as severe heart disease, kidney disease, lung disease, etc;
  • Contraindications to surgery and anesthesia;
  • Unable to obtain informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Shanghai

Shanghai, Shanghai Municipality, 200062, China

RECRUITING

Related Publications (5)

  • Yiu Y, Mahida JB, Cooper JN, Elsey NM, Deans KJ, Minneci PC, Merrill TB, Tobias JD, Elmaraghy CA. The effect of perioperative dexamethasone dosing on post-tonsillectomy hemorrhage risk. Int J Pediatr Otorhinolaryngol. 2017 Jul;98:19-24. doi: 10.1016/j.ijporl.2017.04.033. Epub 2017 Apr 24.

    PMID: 28583496BACKGROUND

  • Sarny S, Ossimitz G, Habermann W, Stammberger H. Hemorrhage following tonsil surgery: a multicenter prospective study. Laryngoscope. 2011 Dec;121(12):2553-60. doi: 10.1002/lary.22347.

    PMID: 22109752BACKGROUND

  • Soderman AC, Odhagen E, Ericsson E, Hemlin C, Hultcrantz E, Sunnergren O, Stalfors J. Post-tonsillectomy haemorrhage rates are related to technique for dissection and for haemostasis. An analysis of 15734 patients in the National Tonsil Surgery Register in Sweden. Clin Otolaryngol. 2015 Jun;40(3):248-54. doi: 10.1111/coa.12361.

    PMID: 25515059BACKGROUND

  • Inuzuka Y, Mizutari K, Kamide D, Sato M, Shiotani A. Risk factors of post-tonsillectomy hemorrhage in adults. Laryngoscope Investig Otolaryngol. 2020 Nov 14;5(6):1056-1062. doi: 10.1002/lio2.488. eCollection 2020 Dec.

    PMID: 33364394BACKGROUND

  • Xu H, Qiu S, Pu S, Hu B, Liu D, Li X. Multicentre clinical study of haemorrhage after coblation tonsillectomy in children: a prospective study protocol. BMJ Open. 2023 Jan 10;13(1):e063401. doi: 10.1136/bmjopen-2022-063401.

    PMID: 36627154DERIVED

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • xiaoyan Li, PhD

    Shanghai Children's Hospital

    STUDY DIRECTOR

Central Study Contacts

Xiaoyan Li, PHD

CONTACT

+8618917128276chhshent@163.com

Hongming Xu, PHD

CONTACT

+8613917086351xuhongming@188.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 25, 2022

Study Start

January 15, 2022

Primary Completion

January 14, 2024

Study Completion

February 28, 2024

Last Updated

November 15, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)