Do antibiotics help the child's recovery after partial tonsillectomy?
| ISRCTN | ISRCTN56916613 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56916613 |
| Secondary identifying numbers | 0001/2010 |
- 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
Not provided at time of registration
Contact information
Dr Olaf Zagólski
Scientific
Scientific
Dunin-W¹sowicza 20/II/3
Kraków
30-112
Poland
Study information
| Study design | Prospective interventional double blinded single centre randomised crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 hypothesis | 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) |
| Condition | 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 | 1. Pain 2. Activity 3. Diet |
| Secondary outcome measures | 1. Odour from the mouth 2. Parental satisfaction |
| Overall study start date | 01/06/2010 |
| Overall study end date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 120 |
| Participant 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 |
| Participant exclusion criteria | 1. Recurrent tonsillitis 2. Previous partial tonsillectomy for the symptoms enumerated above |
| Recruitment start date | 01/06/2010 |
| Recruitment end date | 31/12/2010 |
Locations
Countries of recruitment
- Poland
Study participating centre
Dunin-W¹sowicza 20/II/3
Kraków
30-112
Poland
30-112
Poland
Sponsor information
St. John Grande's Hospital (Poland)
Hospital/treatment centre
Hospital/treatment centre
Day Surgery Department
Kraków
31-061
Poland
Funders
Funder type
Hospital/treatment centre
St. John Grande's Hospital (Poland) - Day Surgery Department
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
