Condition category
Oral Health
Date applied
05/05/2010
Date assigned
20/05/2010
Last edited
20/05/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olaf Zagólski

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0001/2010

Study information

Scientific title

Perioperative antibiotic therapy in adenoidectomy with partial tonsillectomy in children - prospective, interventional, double blinded, single centre, randomised study

Acronym

ABAT

Study hypothesis

Perioperative antibiotic prophylaxis may influence post-operative recovery in children in whom adenotonsillotomy is performed.

Ethics approval

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)

Study design

Prospective interventional double blinded single centre randomised crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Pain
2. Activity
3. Diet

Secondary outcome measures

1. Odour from the mouth
2. Parental satisfaction

Overall trial start date

01/06/2010

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

120

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

Trial participating centre

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

Sponsor information

Organisation

St. John Grande's Hospital (Poland)

Sponsor details

Day Surgery Department
Kraków
31-061
Poland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

St. John Grande's Hospital (Poland) - Day Surgery Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes