Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

NCT06376383 | Not Yet Recruiting DMC

• 2 other identifiers: TETT-RHG110500
• Study Type: interventional
• Target: 464
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obstructive Sleep Apnea; Tonsillar Hypertrophy

Keywords

Tonsillectomy; Obstructive sleep apnea (OSA); Tonsillotomy; Intracapsular reduction of tonsils; Drug Induced Sedation Endoscopy

Outcome Measures

Primary Outcomes (4)

• Postoperative hemorrhage

  Postoperative hemorrhage event - readmission to the hospital

  14 days

• Postoperative pain

  Postoperative pain self-assed daily by using Visual Analoge Scale (VAS) 0 = No pain, 10 = maximal pain.

  30 days

• 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

• 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 Outcomes (2)

• AHI

  180 days

• DISE - VOTE

  180 days

Study Arms (2)

Tonsillectomy

ACTIVE COMPARATOR

Patients undergo standard removal of subcapsular removal of palatine tonsils

Procedure: Tonsillectomy

Tonsillotomy

EXPERIMENTAL

Patients undergo intracapsular reduction of palatine tonsils

Procedure: Tonsillotomy

Interventions

Tonsillectomy PROCEDURE

Standard tonsillectomy

Also known as: TE

Tonsillectomy

Tonsillotomy PROCEDURE

Tonsillotomy

Also known as: TT

Tonsillotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Related Publications (21)

• 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.

  PMID: 27188535 BACKGROUND

• 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.

  PMID: 11991871 BACKGROUND

• 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.

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• 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.

  PMID: 30272383 BACKGROUND

• 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.

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• 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.

  PMID: 15113821 BACKGROUND

• 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.

  PMID: 31587046 BACKGROUND

• 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.

  PMID: 18250209 BACKGROUND

• 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.

  PMID: 21614467 BACKGROUND

• 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.

  PMID: 29627276 BACKGROUND

• 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.

  PMID: 32886102 BACKGROUND

• 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.

  PMID: 29106778 BACKGROUND

• 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.

  PMID: 27005314 BACKGROUND

• 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.

  PMID: 29670412 BACKGROUND

• 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.

  PMID: 35338397 BACKGROUND

• 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.

  PMID: 9450830 BACKGROUND

• 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.

  PMID: 8884405 BACKGROUND

• 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.

  PMID: 29224763 BACKGROUND

• 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.

  PMID: 25807322 BACKGROUND

• 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.

  PMID: 22394550 BACKGROUND

• 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.

  PMID: 29241412 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Kasra Zainali-Gill, Ph.D

CONTACT

+4578439744; kasrzain@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 19, 2024

Record last verified: 2024-04