Tonsil Surgery in Sweden: A National Quality Register

Postoperative Complications Clinical Trial

— NTSRS  

Official title:

The National Tonsil Surgery Register in Sweden

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829515
• Other study ID #: 1111
• Status: Recruiting
• First received: July 8, 2016
• Last updated: March 28, 2018
• Start date: May 2009
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: National Tonsil Surgery Register in Sweden
• Contact: Joacim Stalfors, MD, PhD
• Phone: +46736421613
• Email: joacim[@]stalfors.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

For the purpose of quality assurance, the Swedish Association for Otorhinolaryngology and Head and Neck surgery has developed several national registers concerning ear, nose and throat care. One of these is the National Tonsil Surgery Registry in Sweden (NTSRS). In NTSRS patients undergoing tonsil surgery for benign indications are included. Data regarding indication, surgical methods and techniques as well as patient reported outcomes measures are collected. The register is designed to facilitate description of clinical activities in a unit and help identify the need of clinical improvement programs. By compiling national data, the register can be used to describe clinical practice in a large national cohort.

Description:

The National Tonsil Surgery Register in Sweden (NTSRS), started in 1997 as one among several registers, aimed to reinforce quality in the Swedish health care and were revised 2009. Data in the NTSRS are collected through four questionnaires; two are filled in by the ENT-surgeon and two postoperative forms, filled in by the patient or the legal guardian, collecting patient related outcome measures (PROM) 30 respective 180 days after surgery.

In the first surgeon questionnaire age, sex, social security number and indication for surgery (upper airway obstruction, recurrent tonsillitis, chronic tonsillitis, peritonsillar abscess, and systemic complications because of tonsillitis or other) are recorded. This is filled in when surgery is notified.

The second surgeon questionnaire records surgical method (TE, TEA, TT or TTA), surgical instruments used for dissection (cold steel, radiofrequency, diathermy scissors, ultracision or other) and hemostasis method used (injection with epinephrine, unipolar diathermy, bipolar diathermy, ties, suture ligature, radiofrequency, other or "none other than compression with packs"). The questionnaire also records information regarding daycare/inpatient procedure and primary postoperative bleeding. Due to the configuration of the questionnaires and the ambition to cover both inpatient and daycare procedures, primary bleeding is defined as bleeding during hospitalization.

The first patient/caregiver form contains several questions mainly regarding postoperative complications. Any contact with healthcare provider due to postoperative bleeding/pain/infection as well as consequences of the contact; prescribed antibiotics and readmission/return to theatre are reported. Conformity between preoperative information and actual patient experience was is also included in this form.

The final questionnaire that is sent to the second patient/caregiver questionnaire asks for perceived symptom relief after 180 days by choosing one alternative of four statements: My symptoms are gone / My symptoms are almost gone / My symptoms have not disappeared/ My symptoms have worsened.

In order to assess coverage for the NTSRS, data has been matched on an individual level with another national register, the National Patient Register (NPR). The NPR is managed by the National Board of Health and Welfare and registration of surgical procedures is mandatory by law for all physicians in Sweden. The coverage of NTSRS for the study period 2012-2014 was 75%, 81.4% and 80.7% respectively

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11000
• Est. completion date: December 2019
• Est. primary completion date: March 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients undergoing benign tonsil surgery in Sweden

Exclusion Criteria:

• All patients operated with an C- or D0-48 ICD 10 code, indicating not benign diagnoses

Related Conditions & MeSH terms

• Postoperative Complications
• Prospective Studies
• Registries
• Tonsillectomy

Intervention

Procedure:
• tonsil surgery with or without concomitant adenoidectomy
tonsillectomy, tonsillectomy with adenoidectomy, tonsillotomy, tonsillectomy with adenoidectomy

Locations

Country	Name	City	State
Sweden	National Tonsil Surgery Register in Sweden	Gothenburg

Sponsors (6)

Lead Sponsor	Collaborator
Joacim Stalfors	Karolinska Institutet, Linkoeping University, Region Örebro County, Sahlgrenska University Hospital, Sweden, Swedish Association of Local Authorities and Regions

Country where clinical trial is conducted

Sweden, 

References & Publications (16)

Alm F, Stalfors J, Nerfeldt P, Ericsson E. Patient reported pain-related outcome measures after tonsil surgery: an analysis of 32,225 children from the National Tonsil Surgery Register in Sweden 2009-2016. Eur Arch Otorhinolaryngol. 2017 Oct;274(10):3711- — View Citation

Borgström A, Nerfeldt P, Friberg D, Sunnergren O, Stalfors J. Trends and changes in paediatric tonsil surgery in Sweden 1987-2013: a population-based cohort study. BMJ Open. 2017 Jan 13;7(1):e013346. doi: 10.1136/bmjopen-2016-013346. — View Citation

Elinder K, Söderman AC, Stalfors J, Knutsson J. Factors influencing morbidity after paediatric tonsillectomy: a study of 18,712 patients in the National Tonsil Surgery Register in Sweden. Eur Arch Otorhinolaryngol. 2016 Aug;273(8):2249-56. doi: 10.1007/s0 — View Citation

Gerhardsson H, Stalfors J, Odhagen E, Sunnergren O. Pediatric adenoid surgery in Sweden 2004-2013: Incidence, indications and concomitant surgical procedures. Int J Pediatr Otorhinolaryngol. 2016 Aug;87:61-6. doi: 10.1016/j.ijporl.2016.05.020. Epub 2016 May 20. — View Citation

Gudnadottir G, Tennvall GR, Stalfors J, Hellgren J. Indirect costs related to caregivers' absence from work after paediatric tonsil surgery. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2629-2636. doi: 10.1007/s00405-017-4526-7. Epub 2017 Mar 14. — View Citation

Hallenstål N, Sunnergren O, Ericsson E, Hemlin C, Hessén Söderman AC, Nerfeldt P, Odhagen E, Ryding M, Stalfors J. Tonsil surgery in Sweden 2013-2015. Indications, surgical methods and patient-reported outcomes from the National Tonsil Surgery Register. A — View Citation

Hessén Söderman AC, Ericsson E, Hemlin C, Hultcrantz E, Månsson I, Roos K, Stalfors J. Reduced risk of primary postoperative hemorrhage after tonsil surgery in Sweden: results from the National Tonsil Surgery Register in Sweden covering more than 10 years — View Citation

Hultcrantz E, Ericsson E, Hemlin C, Hessén-Söderman AC, Roos K, Sunnergren O, Stalfors J. Paradigm shift in Sweden from tonsillectomy to tonsillotomy for children with upper airway obstructive symptoms due to tonsillar hypertrophy. Eur Arch Otorhinolaryng — View Citation

Odhagen E, Sunnergren O, Hemlin C, Hessén Söderman AC, Ericsson E, Stalfors J. Risk of reoperation after tonsillotomy versus tonsillectomy: a population-based cohort study. Eur Arch Otorhinolaryngol. 2016 Oct;273(10):3263-8. doi: 10.1007/s00405-015-3871-7. Epub 2016 Jan 4. — View Citation

Odhagen E, Sunnergren O, Söderman AH, Thor J, Stalfors J. Reducing post-tonsillectomy haemorrhage rates through a quality improvement project using a Swedish National quality register: a case study. Eur Arch Otorhinolaryngol. 2018 Mar 24. doi: 10.1007/s00 — View Citation

Østvoll E, Sunnergren O, Ericsson E, Hemlin C, Hultcrantz E, Odhagen E, Stalfors J. Mortality after tonsil surgery, a population study, covering eight years and 82,527 operations in Sweden. Eur Arch Otorhinolaryngol. 2015 Mar;272(3):737-43. doi: 10.1007/s00405-014-3312-z. Epub 2014 Oct 2. — View Citation

Østvoll E, Sunnergren O, Stalfors J. Increasing Readmission Rates for Hemorrhage after Tonsil Surgery: A Longitudinal (26 Years) National Study. Otolaryngol Head Neck Surg. 2018 Jan;158(1):167-176. doi: 10.1177/0194599817725680. Epub 2017 Aug 22. — View Citation

Söderman AC, Odhagen E, Ericsson E, Hemlin C, Hultcrantz E, Sunnergren O, Stalfors J. Post-tonsillectomy haemorrhage rates are related to technique for dissection and for haemostasis. An analysis of 15734 patients in the National Tonsil Surgery Register i — View Citation

Stalfors J, Ericsson E, Hemlin C, Hultcrantz E, Månsson I, Roos K, Hessén Söderman AC. Tonsil surgery efficiently relieves symptoms: analysis of 54 696 patients in the National Tonsil Surgery Register in Sweden. Acta Otolaryngol. 2012 May;132(5):533-9. do — View Citation

Sunnergren O, Hemlin C, Ericsson E, Hessén-Söderman AC, Hultcrantz E, Odhagen E, Stalfors J. Radiofrequency tonsillotomy in Sweden 2009-2012. Eur Arch Otorhinolaryngol. 2014 Jun;271(6):1823-7. doi: 10.1007/s00405-013-2867-4. Epub 2013 Dec 24. — View Citation

Sunnergren O, Odhagen E, Stalfors J. Incidence of second surgery following pediatric adenotonsillar surgery: a population-based cohort study. Eur Arch Otorhinolaryngol. 2017 Jul;274(7):2945-2951. doi: 10.1007/s00405-017-4543-6. Epub 2017 Mar 23. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported symptom relief	The final questionnaire that is sent to the second patient/caregiver questionnaire asks for perceived symptom relief after 180 days by choosing one alternative of four statements: My symptoms are gone / My symptoms are almost gone / My symptoms have not disappeared/ My symptoms have worsened.	6 months postoperative report
Secondary	Patient reported postoperative bleeding	The first patient/caregiver form contains several questions mainly regarding postoperative complications. Any contact with healthcare provider due to postoperative bleeding/pain/infection as well as consequences of the contact; prescribed antibiotics and readmission/return to theatre are reported. Conformity between preoperative information and actual patient experience was is also included in this form.	30 days postoperative report