Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01319058
Brief Summary:
Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines.
the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.
Detailed Description:
Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines.
the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.
In the study three approaches are prospectively compared:
1. Tonsillectomy - using electrocautery resecting all tonsillar tissue.
2. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider.
3. laser Tonsillotomy - reducing tonsillar tissue using a CO2 laser.
All patients will be randomized to one of three arms. Each arm will include 25 children.
All children will have a preoperative and postoperative sleep study. Questioners assessing pain, amount of medication used to control pain and sleep disturbance during the first 7 days after surgery will be filled by the child caretaker.
Blood will be drawn immediately before surgery and 18-24 hours after surgery. The following blood products will be assessed: White blood cells, clotting factors, C reactive protein, IL1 beta,TNF alpha, IL6, IL2.
If the study will show objectively and subjectively that partial resection of the tonsil compared to complete tonsillectomy is less painful and has less postoperative inflammation.
Study:
NCT01319058
Study Brief:
Protocol Section:
NCT01319058