Obstructive Sleep ApneaTVLODNCT01319058
Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea
A study testing Tonsillectomy, laser tonsillotomy, debrider tonsillotomy in people with Obstructive Sleep Apnea, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 2-16 obstructive sleep apnea AHI>5 Hypertrophy of tonsils and adenoids
- -
Who cannot join
- Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome
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.
Read the 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:
- 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
- Keywords
- obstructive sleep apnea, Tonsillectomy, Tonsillotomy, Inflammation, Pain, Post tonsillectomy bleeding
- Medical subject headings
- Sleep Apnea, Obstructive, Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonsillectomy, laser tonsillotomy, debrider tonsillotomyProcedure or surgery
Each arm will be treated by one of the three methods in addition to adenoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery tonsillectomy | Active comparator | Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea Receives: Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy |
| Debrider tonsillotomy | Active comparator | Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea. Receives: Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy |
| Laser tonsillotomy | Active comparator | Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea. Receives: Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.
Measured: 12 months
Secondary outcomes (1)
Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben-Zion Joshua, Soroka University Medical Center
- Investigators
- Marc M Puterman, MD, Principal investigator, Soroka University Medical CenterAviv D Goldbart, MD, Study director, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319058
- Sponsor's protocol ID
- sor495810ctil
- Acronym
- TVLOD
- Status last verified
- Oct 2016
- First submitted
- 17 Mar 2011
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Friedman BC, Hendeles-Amitai A, Kozminsky E, Leiberman A, Friger M, Tarasiuk A, Tal A. Adenotonsillectomy improves neurocognitive function in children with obstructive sleep apnea syndrome. Sleep. 2003 Dec 15;26(8):999-1005. doi: 10.1093/sleep/26.8.999.
PubMed 14746381Ericsson E, Lundeborg I, Hultcrantz E. Child behavior and quality of life before and after tonsillotomy versus tonsillectomy. Int J Pediatr Otorhinolaryngol. 2009 Sep;73(9):1254-62. doi: 10.1016/j.ijporl.2009.05.015. Epub 2009 Jun 17.
PubMed 19539380Anand A, Vilela RJ, Guarisco JL. Intracapsular versus standard tonsillectomy: review of literature. J La State Med Soc. 2005 Sep-Oct;157(5):259-61.
PubMed 16374970Blackshaw H, Springford LR, Zhang LY, Wang B, Venekamp RP, Schilder AG. Tonsillectomy versus tonsillotomy for obstructive sleep-disordered breathing in children. Cochrane Database Syst Rev. 2020 Apr 29;4(4):CD011365. doi: 10.1002/14651858.CD011365.pub2.
PubMed 32347984
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome
- ClinicalTrials.gov ID
- NCT01319058
- Acronym / sponsor ID
- TVLOD / sor495810ctil
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, Tonsillectomy, Tonsillotomy, Inflammation, Pain, Post tonsillectomy bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electrocautery tonsillectomy | Active comparator | Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomyChildren undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea |
| Debrider tonsillotomy | Active comparator | Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomyChildren undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea. |
| Laser tonsillotomy | Active comparator | Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomyChildren undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 2-16 obstructive sleep apnea AHI>5 Hypertrophy of tonsils and adenoids
- -
Key exclusion criteria (1 listed)
- Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tonsillectomy, laser tonsillotomy, debrider tonsillotomyEach arm will be treated by one of the three methods in addition to adenoidectomy | Procedure or surgery | Debrider tonsillotomy, Electrocautery tonsillectomy, Laser tonsillotomy |
Primary outcome
Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.
Time frame: 12 months
1 secondary outcome
Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Background: PubMed 14746381Friedman BC, Hendeles-Amitai A, Kozminsky E, Leiberman A, Friger M, Tarasiuk A, Tal A. Adenotonsillectomy improves neurocognitive function in children with obstructive sleep apnea syndrome. Sleep. 2003 Dec 15;26(8):999-1005. doi: 10.1093/sleep/26.8.999.
- Background: PubMed 19539380Ericsson E, Lundeborg I, Hultcrantz E. Child behavior and quality of life before and after tonsillotomy versus tonsillectomy. Int J Pediatr Otorhinolaryngol. 2009 Sep;73(9):1254-62. doi: 10.1016/j.ijporl.2009.05.015. Epub 2009 Jun 17.
- Background: PubMed 16374970Anand A, Vilela RJ, Guarisco JL. Intracapsular versus standard tonsillectomy: review of literature. J La State Med Soc. 2005 Sep-Oct;157(5):259-61.
- Derived from this study: PubMed 32347984Blackshaw H, Springford LR, Zhang LY, Wang B, Venekamp RP, Schilder AG. Tonsillectomy versus tonsillotomy for obstructive sleep-disordered breathing in children. Cochrane Database Syst Rev. 2020 Apr 29;4(4):CD011365. doi: 10.1002/14651858.CD011365.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc M Puterman, MD principal investigator
Soroka University Medical Center
Aviv D Goldbart, MD study director
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsillectomy, laser tonsillotomy, debrider tonsillotomy in people with Obstructive Sleep Apnea, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319058, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.