Clinical trial NCT05206799: The CMCPCTH Research in Chinese Children
Official title: A Multi-centre Clinical Study of Hemorrhage Rate After Coblation Tonsillectomy in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tonsillectomy
Child
Postoperative Hemorrhage
Keywords: Tonsillectomy
child
Postoperative Hemorrhage
low-temperature plasma radiofrequency ablation
Lead sponsor: Shanghai Children's Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan provincial maternity and child health care hospital
name: Maternity and Child Health Care Hospital of Pingdingshan City
name: Shanxi Provincial Maternity and Children's Hospital
name: The Children's Hospital of Xi'an City
name: Xiamen Children's Hospital
name: Anyang Maternal and Child Health Care Center
name: Ningbo Women & Children's Hospital
name: Children's Hospital of Chongqing Medical University
name: Wuhan Union Hospital, China
name: Maternity and Child Health Care Hospital of Tangshan city
name: Children's Hospital Affiliated to Kunming Medical University
name: Materal and Child Health Hospital of Hubei Province
name: Hunan Children's Hospital
name: Zhengzhou Children's Hospital, China
name: The Children's Hospital Zhejiang University Shcool of Medicine
name: Tianjin Children's Hospital
name: Chengdu Women's and Children's Central Hospital,School of Medicine, University of Electronic Science and Technology of China
name: Shenzhen Hospital of Southern Medical University
name: Yuying Children's Hospital, second Affiliated Hospital of Wenzhou Medical University
name: Jinan children's hospital
name: People's Hospital of Hunan Provincial
name: First People's Hospital of Foshan
name: Jiangxi Children's Hospital
name: Dalian Women and Children medical Center (Group)
name: Wuxi Women's & Children's Hospital
First posted: 2022-01-25
Enrollment: 25000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled patiens are children who underwent coblation tonsillectomy from multi-centers in different provinces of China.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: hemorrhage rate after coblation tonsillectomy
timeFrame: 3 weeks after surgery
measure: risk factors of hemorrhage after coblation tonsillectomy
timeFrame: 3 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
state: Shanghai
Study officials:
affiliation: Shanghai Children's Hospital
name: xiaoyan Li, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
citation: 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.