The CMCPCTH Research in Chinese Children

• Conditions: Tonsillectomy; Postoperative Hemorrhage; Child

• Registration Number: NCT05206799
• Lead Sponsor: Shanghai Children's Hospital

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 hemorrhage after coblation tonsillectomy will be investigated through questionnaires.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study Start: 2022-01-15
• Study First Posted: 2022-01-25
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-15
• Primary Completion: 2024-01-14
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hemorrhage rate after coblation tonsillectomy	3 weeks after surgery	hemorrhage rate after coblation tonsillectomy in children within 3 weeks
risk factors of hemorrhage after coblation tonsillectomy	3 weeks after surgery	risk factors of hemorrhage after coblation tonsillectomy in children

Trial Locations

Locations (1)

Children's Hospital of Shanghai; 🇨🇳 Shanghai, Shanghai, China