Tonsil Surgery in Sweden: A National Quality Register

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

11000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Tonsillectomy Prospective Studies Registries Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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tonsil surgery with or without concomitant adenoidectomy

tonsillectomy, tonsillectomy with adenoidectomy, tonsillotomy, tonsillectomy with adenoidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Joacim Stalfors

Register Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joacim Stalfors, MD, PhD

Role: STUDY_DIRECTOR

Sahlgrenska Academy

Locations

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National Tonsil Surgery Register in Sweden

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Joacim Stalfors, MD, PhD

Role: CONTACT

Phone: +46736421613

Email: [email protected]

Lisa Hellgård

Role: CONTACT

Email: [email protected]

Facility Contacts

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Lisa Hellgård, MSc

Role: primary

Reference Type RESULT

PMID: 28598766 (View on PubMed)

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.

Reference Type RESULT

PMID: 28289832 (View on PubMed)

Other Identifiers

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1111

Identifier Type: -

Identifier Source: org_study_id

Tonsil Surgery in Sweden: A National Quality Register

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Interventions

tonsil surgery with or without concomitant adenoidectomy

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Swedish Association of Local Authorities and Regions

Sahlgrenska University Hospital

Karolinska Institutet

Linkoeping University

Region Örebro County

Joacim Stalfors

Responsible Party

Joacim Stalfors

Principal Investigators

Joacim Stalfors, MD, PhD

Locations

National Tonsil Surgery Register in Sweden

Countries

Central Contacts

Joacim Stalfors, MD, PhD

Lisa Hellgård

Facility Contacts

Lisa Hellgård, MSc

References

Odhagen E, Sunnergren O, Hemlin C, Hessen Soderman 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.

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.

Ostvoll 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.

Ostvoll 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.

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.

Borgstrom 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.

Elinder K, Soderman 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/s00405-016-4001-x. Epub 2016 Mar 28.

Sunnergren O, Hemlin C, Ericsson E, Hessen-Soderman 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.

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.

Other Identifiers

1111