Soroka Hospital
Beersheba, 84101, Israel
NCT Number: NCT01319058
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.
Looking for future studies?
Notify Me2 year–16 year
All sexes
Interventional
Not applicable
Beersheba, 84101, Israel
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
age 2-16 obstructive sleep apnea AHI>5 Hypertrophy of tonsils and adenoids
-
Exclusion criteria
Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome
Each arm will be treated by one of the three methods in addition to adenoidectomy
Time frame: 12 months
Time frame: 12 months
Soroka University Medical Center
Other
Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome
Acronym: TVLOD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04928157
Apnea, Chronic Pain
San Diego, California, United States
View Trial DetailsNCT04832711
Apnea, Dyssomnias
Beijing, China
View Trial DetailsNCT05535179
Apnea, Complication
Shijiazhuang, Hebei, China
View Trial DetailsNCT02325687
Apnea, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
New York, United States
View Trial Details