Status:

UNKNOWN

The CMCPCTH Research in Chinese Children

Lead Sponsor:

Shanghai Children's Hospital

Collaborating Sponsors:

Sichuan provincial maternity and child health care hospital

Maternity and Child Health Care Hospital of Pingdingshan City

Conditions:

Tonsillectomy

Child

Eligibility:

All Genders

Up to 18 years

Brief Summary

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

Detailed Description

This study is a prospective and multi-centre trail in China. It intends to enroll 25000 patients underwent coblation tonsillectomy in 22 clinical centers in China. Hemorrhage rate and risk factors of ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

January 15 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 28 2024

Estimated Enrollment :

25000 Patients enrolled

Trial Details

Trial ID

NCT05206799

Start Date

January 15 2022

End Date

February 28 2024

Last Update

November 15 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Children's Hospital of Shanghai

Shanghai, Shanghai Municipality, China, 200062