The CMCPCTH Research in Chinese Children

Child Clinical Trial

Official title:

A Multi-centre Clinical Study of Hemorrhage Rate After Coblation Tonsillectomy in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206799
• Other study ID #: 2021R096-E01
• Status: Recruiting
• Start date: January 15, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: January 2022
• Source: Shanghai Children's Hospital
• Contact: Xiaoyan Li, PHD
• Phone: +8618917128276
• Email: chhshent[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: February 28, 2024
• Est. primary completion date: January 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child
• Hemorrhage
• Postoperative Hemorrhage
• Tonsillectomy

Locations

Country	Name	City	State
China	Children's Hospital of Shanghai	Shanghai	Shanghai

Sponsors (26)

Lead Sponsor

Collaborator

Shanghai Children's Hospital

Anyang Maternal and Child Health Care Center, Chengdu Women's and Children's Central Hospital,School of Medicine, University of Electronic Science and Technology of China, Children's Hospital Affiliated to Kunming Medical University, Children's Hospital of Chongqing Medical University, Dalian Women and Children medical Center (Group), Foshan First People's Hospital, Hunan Children's Hospital, Jiangxi Children's Hospital, Jinan children's hospital, Materal and Child Health Hospital of Hubei Province, Maternity and Child Health Care Hospital of Pingdingshan City, Maternity and Child Health Care Hospital of Tangshan city, Ningbo Women & Children's Hospital, People's Hospital of Hunan Provincial, Shanxi Provincial Maternity and Children's Hospital, Shenzhen Hospital of Southern Medical University, Sichuan provincial maternity and child health care hospital, The Children's Hospital of Xi'an City, The Children's Hospital Zhejiang University Shcool of Medicine, Tianjin Children's Hospital, Wuhan Union Hospital, China, Wuxi Children's Hospital, Xiamen Children's Hospital, Yuying Children's Hospital, second Affiliated Hospital of Wenzhou Medical University, Zhengzhou Children's Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

Söderman 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemorrhage rate after coblation tonsillectomy	hemorrhage rate after coblation tonsillectomy in children within 3 weeks	3 weeks after surgery
Primary	risk factors of hemorrhage after coblation tonsillectomy	risk factors of hemorrhage after coblation tonsillectomy in children	3 weeks after surgery