Do antibiotics help the child's recovery after partial tonsillectomy?

ISRCTN	ISRCTN56916613
DOI	https://doi.org/10.1186/ISRCTN56916613
Protocol serial number	0001/2010
Sponsor	St. John Grande's Hospital (Poland)
Funder	St. John Grande's Hospital (Poland) - Day Surgery Department

Submission date: 05/05/2010
Registration date: 20/05/2010
Last edited: 20/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Olaf Zagólski
Scientific

Dunin-W¹sowicza 20/II/3
Kraków
30-112
Poland

Study information

Primary study design	Interventional
Study design	Prospective interventional double blinded single centre randomised crossover group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Perioperative antibiotic therapy in adenoidectomy with partial tonsillectomy in children - prospective, interventional, double blinded, single centre, randomised study
Study acronym	ABAT
Study objectives	Perioperative antibiotic prophylaxis may influence post-operative recovery in children in whom adenotonsillotomy is performed.
Ethics approval(s)	Bioethics Commission at the Regional Medical Chamber in Krakow (Komisja Bioetyczna przy Okręgowej Izbie Lekarskiej w Krakowie, Opinia) approved on the 23rd of Dec 2009 (ref: 178/KBL/iL/2009)
Health condition(s) or problem(s) studied	Adenoidal and tonsillar hyperplasia
Intervention	Curette adenoidectomy with scissors tonsillectomy. Oral administration of clindamycine prior to (one dose) and after (2 doses) the surgery. The total duration of follow up for this trial will be 3 weeks. The primary and secondary outcomes will be measured at 7, 14 and 21 post-operative days. The children's caregivers will fill a questionnare answering a standardised set of questions concerning the measures. the participants will be questioned about pain intensity using faces Pain Scale 1-10, the caregivers' satisfaction will be rated along 0-10 scale. Diet, physical activity and malorour from the mouth will be analysed according to the parent diary. Joint sponsor: Trialist will report results and any problems to the Bioethics Commission at the Regional Medical Chamber in Krakow (Komisja Bioetyczna przy Okręgowej Izbie Lekarskiej w Krakowie) on an annual basis
Intervention type	Other
Primary outcome measure(s)	1. Pain 2. Activity 3. Diet
Key secondary outcome measure(s)	1. Odour from the mouth 2. Parental satisfaction
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	14 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Paediatric patients age 3-14 2. Indications for adenoidectomy with partial tonsillectomy 3. Hyperplasia of adenoid and palatine tonsils causing obstructive symptoms, identified from descriptions by the caregivers: snoring, gasping, choking as well as apnoeic episodes, and/or ear effusions
Key exclusion criteria	1. Recurrent tonsillitis 2. Previous partial tonsillectomy for the symptoms enumerated above
Date of first enrolment	01/06/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Poland

Study participating centre

Dunin-W¹sowicza 20/II/3

Kraków
30-112
Poland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes