Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.
Recurrent otitis media is the most common bacterial disease in young children. Many risk factors are known, but benefit of operations are conflicting in children under two years of age.
In this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. A control group with no active treatment is also included. The speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. Life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adenoidectomy and tymapanostomy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| - number of acute otitis media | ||
| - quality of life issues |
| Measure | Description | Time Frame |
|---|---|---|
| - time to first recurrence | ||
| - speed of recovery of each otitis media | ||
| - number of days of middle ear effusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Petri Koivunen, PhD | Dept of Otolaryngology, University of Oulu, Finland | Study Director |
| Olli-Pekka Alho, professor | Dept of Otolaryngology, University of Oulu, Finland | Principal Investigator |
| Matti Uhari, professor | Dept of Pediatrics, University of Oulu, Finland | Study Director |
| Tiia Kujala, MD | Dept of Otolaryngology, University of Oulu, Finland | Principal Investigator |
| Jukka Luotonen, PhD | Dept of Otolaryngology, University of Oulu, Finland | Study Director |
| Aila Kristo, MD | Dept of Otolaryngology, University of Oulu, Finland | Principal Investigator |
| Marjo Renko, PhD | Dept of pediatrics, University of Oulu, Finland | Principal Investigator |
| Tero Kontiokari, PhD | Dept of pediatrics, University of Oulu, Finland | Principal Investigator |
| Tytti Pokka, FK | Dept of pediatrics, University of Oulu, Finland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24445832 | Derived | Kujala T, Alho OP, Kristo A, Uhari M, Renko M, Pokka T, Koivunen P. Quality of life after surgery for recurrent otitis media in a randomized controlled trial. Pediatr Infect Dis J. 2014 Jul;33(7):715-9. doi: 10.1097/INF.0000000000000265. | |
| 22466327 | Derived | Kujala T, Alho OP, Luotonen J, Kristo A, Uhari M, Renko M, Kontiokari T, Pokka T, Koivunen P. Tympanostomy with and without adenoidectomy for the prevention of recurrences of acute otitis media: a randomized controlled trial. Pediatr Infect Dis J. 2012 Jun;31(6):565-9. doi: 10.1097/INF.0b013e318255ddde. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000233 | Adenoidectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| - number of upper respiratory infections |
| - prevention of otitis media caused by pnemococcus in carrier of pneumococcus |
| Principal Investigator |