Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Tonsillectomy Versus Tonsillotomy in Adults With Obstructive Sleep Apnea; a Randomized Controlled Trial Comparing Postoperative Morbidity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376383
• Other study ID #: TETT-RHG
• Secondary ID: 110500
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: September 2027

Study information

• Verified date: April 2024
• Source: University of Aarhus
• Contact: Kasra Zainali-Gill, Ph.D
• Phone: +4578439744
• Email: kasrzain[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 464
• Est. completion date: September 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age > 18 years
• Tonsil size 2, 3, or 4 (Friedman tonsil scale)
• Confirmed OSA with sleep analysis not older than a year either CRM or PSG
• ASA 1 or 2
• BMI < 35 kg/m2 Exclusion Criteria: Children age < 18 years
• Previous pharyngeal surgery such as previous tonsillotomy, tonsillectomy or palatal surgery
• Epileptic disease or severe neurological comorbidity.
• ASA 3, or 4.
• Central sleep apnea
• Previous thrombotic disease.
• Currently treated with sleep medications
• No collapse of oropharyngeal lateral wall during DISE
• Dropout of study, lack of sleep analysis or lack of postoperative DISE.

Related Conditions & MeSH terms

• Apnea
• Hypertrophy
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Tonsillar Hypertrophy

Intervention

Procedure:
• Tonsillectomy
Standard tonsillectomy
• Tonsillotomy
Tonsillotomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

References & Publications (21)

Acevedo JL, Shah RK, Brietzke SE. Systematic review of complications of tonsillotomy versus tonsillectomy. Otolaryngol Head Neck Surg. 2012 Jun;146(6):871-9. doi: 10.1177/0194599812439017. Epub 2012 Mar 6. — View Citation

Camacho M, Li D, Kawai M, Zaghi S, Teixeira J, Senchak AJ, Brietzke SE, Frasier S, Certal V. Tonsillectomy for adult obstructive sleep apnea: A systematic review and meta-analysis. Laryngoscope. 2016 Sep;126(9):2176-86. doi: 10.1002/lary.25931. Epub 2016 Mar 22. — View Citation

Drager LF, McEvoy RD, Barbe F, Lorenzi-Filho G, Redline S; INCOSACT Initiative (International Collaboration of Sleep Apnea Cardiovascular Trialists). Sleep Apnea and Cardiovascular Disease: Lessons From Recent Trials and Need for Team Science. Circulation. 2017 Nov 7;136(19):1840-1850. doi: 10.1161/CIRCULATIONAHA.117.029400. — View Citation

Fietze I, Laharnar N, Obst A, Ewert R, Felix SB, Garcia C, Glaser S, Glos M, Schmidt CO, Stubbe B, Volzke H, Zimmermann S, Penzel T. Prevalence and association analysis of obstructive sleep apnea with gender and age differences - Results of SHIP-Trend. J Sleep Res. 2019 Oct;28(5):e12770. doi: 10.1111/jsr.12770. Epub 2018 Oct 1. — View Citation

Kezirian EJ, Hohenhorst W, de Vries N. Drug-induced sleep endoscopy: the VOTE classification. Eur Arch Otorhinolaryngol. 2011 Aug;268(8):1233-1236. doi: 10.1007/s00405-011-1633-8. Epub 2011 May 26. — View Citation

Lechner M, Wilkins D, Kotecha B. A review on drug-induced sedation endoscopy - Technique, grading systems and controversies. Sleep Med Rev. 2018 Oct;41:141-148. doi: 10.1016/j.smrv.2018.02.001. Epub 2018 Feb 24. — View Citation

Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. — View Citation

MacKay S, Carney AS, Catcheside PG, Chai-Coetzer CL, Chia M, Cistulli PA, Hodge JC, Jones A, Kaambwa B, Lewis R, Ooi EH, Pinczel AJ, McArdle N, Rees G, Singh B, Stow N, Weaver EM, Woodman RJ, Woods CM, Yeo A, McEvoy RD. Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial. JAMA. 2020 Sep 22;324(12):1168-1179. doi: 10.1001/jama.2020.14265. — View Citation

Myssiorek D, Alvi A. Post-tonsillectomy hemorrhage: an assessment of risk factors. Int J Pediatr Otorhinolaryngol. 1996 Sep;37(1):35-43. doi: 10.1016/0165-5876(96)01364-x. — View Citation

Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901. — View Citation

Randall DA, Hoffer ME. Complications of tonsillectomy and adenoidectomy. Otolaryngol Head Neck Surg. 1998 Jan;118(1):61-8. doi: 10.1016/S0194-5998(98)70376-6. — View Citation

Rashwan MS, Montevecchi F, Cammaroto G, Badr El Deen M, Iskander N, El Hennawi D, El Tabbakh M, Meccariello G, Gobbi R, Stomeo F, Vicini C. Evolution of soft palate surgery techniques for obstructive sleep apnea patients: A comparative study for single-level palatal surgeries. Clin Otolaryngol. 2018 Apr;43(2):584-590. doi: 10.1111/coa.13027. Epub 2017 Dec 3. — View Citation

Reckley LK, Fernandez-Salvador C, Camacho M. The effect of tonsillectomy on obstructive sleep apnea: an overview of systematic reviews. Nat Sci Sleep. 2018 Apr 4;10:105-110. doi: 10.2147/NSS.S127816. eCollection 2018. — View Citation

Sjoblom HM, Nahkuri M, Suomela M, Jero J, Piitulainen JM. Treatment of sleep apnoea with tonsillectomy: a retrospective analysis using long-term follow-up data. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3727-3732. doi: 10.1007/s00405-022-07350-6. Epub 2022 Mar 25. — View Citation

Van Ryswyk E, Anderson CS, Antic NA, Barbe F, Bittencourt L, Freed R, Heeley E, Liu Z, Loffler KA, Lorenzi-Filho G, Luo Y, Margalef MJM, McEvoy RD, Mediano O, Mukherjee S, Ou Q, Woodman R, Zhang X, Chai-Coetzer CL. Predictors of long-term adherence to continuous positive airway pressure in patients with obstructive sleep apnea and cardiovascular disease. Sleep. 2019 Oct 9;42(10):zsz152. doi: 10.1093/sleep/zsz152. — View Citation

Wang H, Fu Y, Feng Y, Guan J, Yin S. Tonsillectomy versus tonsillotomy for sleep-disordered breathing in children: a meta analysis. PLoS One. 2015 Mar 25;10(3):e0121500. doi: 10.1371/journal.pone.0121500. eCollection 2015. — View Citation

Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG. — View Citation

Wong Chung JERE, van Benthem PPG, Blom HM. Tonsillotomy versus tonsillectomy in adults suffering from tonsil-related afflictions: a systematic review. Acta Otolaryngol. 2018 May;138(5):492-501. doi: 10.1080/00016489.2017.1412500. Epub 2017 Dec 15. — View Citation

Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080. — View Citation

Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA. 2004 Apr 28;291(16):2013-6. doi: 10.1001/jama.291.16.2013. No abstract available. — View Citation

Zhang LY, Zhong L, David M, Cervin A. Tonsillectomy or tonsillotomy? A systematic review for paediatric sleep-disordered breathing. Int J Pediatr Otorhinolaryngol. 2017 Dec;103:41-50. doi: 10.1016/j.ijporl.2017.10.008. Epub 2017 Oct 5. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hemorrhage	Postoperative hemorrhage event - readmission to the hospital	14 days
Primary	Postoperative pain	Postoperative pain self-assed daily by using Visual Analoge Scale (VAS) 0 = No pain, 10 = maximal pain.	30 days
Primary	Recovery time - Sick leave	Sick-leave in days, measured when the patient is at work or back at school, day 0 = surgery day and outcome day is last day of sick-leave	30 days
Primary	Morbidity	Re-admission at the hospital. Event is registered as null if no re-admission occurs and 1 or 2 etc. if re-admission occurs within first 30 days after surgery	30 days
Secondary	AHI	Apnea Hypopnea Index before and after surgery. Increase in AHI means worsening in apnea hypopnea index. AHI is measured by performing at home type 3 sleep registration	180 days
Secondary	DISE - VOTE	Velum Oropharyngeal Tongue base Epiglottis (VOTE) evaluation. 0 = no collaps; = partial collaps; = complete collaps	180 days