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NCT Number: NCT01319058

Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea

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.

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Key information

About this study

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:

  • Tonsillectomy - using electrocautery resecting all tonsillar tissue.
  • Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider.
  • 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.

Who can participate

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

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Exclusion criteria

Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome

Treatment and study plan

Tonsillectomy, laser tonsillotomy, debrider tonsillotomy

Procedure

Each arm will be treated by one of the three methods in addition to adenoidectomy

Primary outcomes

  1. Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.

    Time frame: 12 months

Secondary outcomes

  1. Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome

Acronym: TVLOD

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2011
Registry last updated
Oct 18, 2016

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.

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