TonsillectomyNCT05206799
The CMCPCTH Research in Chinese Children
An observational study of Tonsillectomy and Child, run by Shanghai Children's Hospital at 1 site in China.
Trial summary
To obtain hemorrhage rate after coblation tonsillectomy, and to investigate risk factors of hemorrhage after coblation tonsillectomy in children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Tonsillectomy, Child, Postoperative Hemorrhage
- How many people
- 25,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2022to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Enrolled patiens are children who underwent coblation tonsillectomy from multi-centers in different provinces of China.
Who may be able to join
- under 18 years old;
- Clear indications for tonsill surgery;
- No clear contraindications for tonsill surgery;
- Parents of the children patients accept surgical treatment;
- Parents of the children patients able to cooperate with the visit and follow-up.
Who cannot join
- Children patients with a history of adenoid or tonsillectomy surgery;
- Associated with refractory bleeding diseases;
- Combined with cleft palate;
- Down syndrome, Prader-Willi syndrome (PWS) or other chromosomal abnormalities;
- Neuromuscular diseases (including cerebral palsy);
- Other diseases that affect physical health, such as severe heart disease, kidney disease, lung disease, etc;
- Contraindications to surgery and anesthesia;
- Unable to obtain informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200062
Hongming Xu, PHD, +8613917086351, xuhongming@188.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Tonsillectomy, Child, Postoperative Hemorrhage
- Keywords
- Tonsillectomy, child, Postoperative Hemorrhage, low-temperature plasma radiofrequency ablation
- Medical subject headings
- Postoperative Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
hemorrhage rate after coblation tonsillectomy
hemorrhage rate after coblation tonsillectomy in children within 3 weeks
Measured: 3 weeks after surgery
risk factors of hemorrhage after coblation tonsillectomy
risk factors of hemorrhage after coblation tonsillectomy in children
Measured: 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start15 Jan 2022
- Primary completion14 Jan 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan provincial maternity and child health care hospital, Maternity and Child Health Care Hospital of Pingdingshan City, Shanxi Provincial Maternity and Children's Hospital, The Children's Hospital of Xi'an City, Xiamen Children's Hospital, Anyang Maternal and Child Health Care Center, Ningbo Women & Children's Hospital, Children's Hospital of Chongqing Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Maternity and Child Health Care Hospital of Tangshan city, Children's Hospital Affiliated to Kunming Medical University, Maternal and Child Health Hospital of Hubei Province, Hunan Children's Hospital, Zhengzhou Children's Hospital, China, The Children's Hospital of Zhejiang University School of Medicine, Tianjin Children's Hospital, Chengdu Women's and Children's Central Hospital, Shenzhen Hospital of Southern Medical University, Second Affiliated Hospital of Wenzhou Medical University, Children's Hospital Affiliated to Shandong University, People's Hospital of Hunan Provincial, First People's Hospital of Foshan, Jiangxi Province Children's Hospital, Dalian Women and Children's Medical Center, Wuxi Women's & Children's Hospital
- Responsible party
- Sponsor
- Investigators
- xiaoyan Li, PhD, Study director, Shanghai Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206799
- Sponsor's protocol ID
- 2021R096-E01
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28583496Sarny 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.
PubMed 22109752Soderman 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.
PubMed 25515059Inuzuka 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.
PubMed 33364394Xu 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.
PubMed 36627154
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Clinical Study of Hemorrhage Rate After Coblation Tonsillectomy in Children
- ClinicalTrials.gov ID
- NCT05206799
- Acronym / sponsor ID
- 2021R096-E01
- Conditions
- Tonsillectomy, Child, Postoperative Hemorrhage
- Keywords
- Tonsillectomy, child, Postoperative Hemorrhage, low-temperature plasma radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Shanghai Children's HospitalUniversity, hospital or other
- Collaborators
- Sichuan provincial maternity and child health care hospital, Maternity and Child Health Care Hospital of Pingdingshan City, Shanxi Provincial Maternity and Children's Hospital, The Children's Hospital of Xi'an City, Xiamen Children's Hospital, Anyang Maternal and Child Health Care Center, Ningbo Women & Children's Hospital, Children's Hospital of Chongqing Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Maternity and Child Health Care Hospital of Tangshan city, Children's Hospital Affiliated to Kunming Medical University, Maternal and Child Health Hospital of Hubei Province, Hunan Children's Hospital, Zhengzhou Children's Hospital, China, The Children's Hospital of Zhejiang University School of Medicine, Tianjin Children's Hospital, Chengdu Women's and Children's Central Hospital, Shenzhen Hospital of Southern Medical University, Second Affiliated Hospital of Wenzhou Medical University, Children's Hospital Affiliated to Shandong University, People's Hospital of Hunan Provincial, First People's Hospital of Foshan, Jiangxi Province Children's Hospital, Dalian Women and Children's Medical Center, Wuxi Women's & Children's Hospital
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 14 Jan 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Enrolled patiens are children who underwent coblation tonsillectomy from multi-centers in different provinces of China.
Key inclusion criteria (5 listed)
- under 18 years old;
- Clear indications for tonsill surgery;
- No clear contraindications for tonsill surgery;
- Parents of the children patients accept surgical treatment;
- Parents of the children patients able to cooperate with the visit and follow-up.
Key exclusion criteria (8 listed)
- Children patients with a history of adenoid or tonsillectomy surgery;
- Associated with refractory bleeding diseases;
- Combined with cleft palate;
- Down syndrome, Prader-Willi syndrome (PWS) or other chromosomal abnormalities;
- Neuromuscular diseases (including cerebral palsy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hemorrhage rate after coblation tonsillectomy
Time frame: 3 weeks after surgery
hemorrhage rate after coblation tonsillectomy in children within 3 weeks
risk factors of hemorrhage after coblation tonsillectomy
Time frame: 3 weeks after surgery
risk factors of hemorrhage after coblation tonsillectomy in children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Background: PubMed 28583496Yiu 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.
- Background: PubMed 22109752Sarny 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.
- Background: PubMed 25515059Soderman 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.
- Background: PubMed 33364394Inuzuka 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.
- Derived from this study: PubMed 36627154Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaoyan Li, PhD study director
Shanghai Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillectomy and Child, run by Shanghai Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Li, PHD (+8618917128276, chhshent@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemorrhage rate after coblation tonsillectomy (time frame: 3 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05206799, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.