The CMCPCTH Research in Chinese Children

NCT ID: NCT05206799

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-15

Study Completion Date

2024-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Tonsillectomy Child Postoperative Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan provincial maternity and child health care hospital

UNKNOWN

Sponsor Role collaborator

Maternity and Child Health Care Hospital of Pingdingshan City

UNKNOWN

Sponsor Role collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role collaborator

The Children's Hospital of Xi'an City

UNKNOWN

Sponsor Role collaborator

Xiamen Children's Hospital

OTHER

Sponsor Role collaborator

Anyang Maternal and Child Health Care Center

UNKNOWN

Sponsor Role collaborator

Ningbo Women & Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Maternity and Child Health Care Hospital of Tangshan city

UNKNOWN

Sponsor Role collaborator

Children's Hospital Affiliated to Kunming Medical University

UNKNOWN

Sponsor Role collaborator

Materal and Child Health Hospital of Hubei Province

UNKNOWN

Sponsor Role collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Zhengzhou Children's Hospital, China

OTHER

Sponsor Role collaborator

The Children's Hospital Zhejiang University Shcool of Medicine

UNKNOWN

Sponsor Role collaborator

Tianjin Children's Hospital

OTHER

Sponsor Role collaborator

Chengdu Women's and Children's Central Hospital

OTHER

Sponsor Role collaborator

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role collaborator

Yuying Children's Hospital, second Affiliated Hospital of Wenzhou Medical University

UNKNOWN

Sponsor Role collaborator

Jinan children's hospital

UNKNOWN

Sponsor Role collaborator

People's Hospital of Hunan Provincial

UNKNOWN

Sponsor Role collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role collaborator

Jiangxi Children's Hospital

UNKNOWN

Sponsor Role collaborator

Dalian Women and Children medical Center (Group)

UNKNOWN

Sponsor Role collaborator

Wuxi Women's & Children's Hospital

OTHER

Sponsor Role collaborator

Shanghai Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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xiaoyan Li, PhD

Role: STUDY_DIRECTOR

Shanghai Children's Hospital

Locations

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Children's Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyan Li, PHD

Role: CONTACT

+8618917128276

Hongming Xu, PHD

Role: CONTACT

+8613917086351

Facility Contacts

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Hongming Xu, PHD

Role: primary

+8613917086351

References

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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.

Reference Type BACKGROUND
PMID: 28583496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22109752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25515059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33364394 (View on PubMed)

Xu H, Qiu S, Pu S, Hu B, Liu D, Li X. Multicentre clinical study of haemorrhage after coblation tonsillectomy in children: a prospective study protocol. BMJ Open. 2023 Jan 10;13(1):e063401. doi: 10.1136/bmjopen-2022-063401.

Reference Type DERIVED
PMID: 36627154 (View on PubMed)

Other Identifiers

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2021R096-E01

Identifier Type: -

Identifier Source: org_study_id

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