The CMCPCTH Research in Chinese Children

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

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

Study Overview

• Status: Recruiting
• Conditions: Child; Postoperative Hemorrhage; Tonsillectomy

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 Type: Observational
• Enrollment (Anticipated): 25000

Contacts and Locations

• Study Contact: Name: Xiaoyan Li, PHD; Phone Number: +8618917128276; Email: chhshent@163.com
• Study Contact Backup: Name: Hongming Xu, PHD; Phone Number: +8613917086351; Email: xuhongming@188.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200062
      • Recruiting
      • Children's Hospital of Shanghai
      • Contact: Hongming Xu, PHD; Phone Number: +8613917086351; Email: xuhongming@188.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Anticipated): January 14, 2024
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: child; Tonsillectomy; Postoperative Hemorrhage; low-temperature plasma radiofrequency ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage
• Other Study ID Numbers: 2021R096-E01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No