NCT03326661

Brief Summary

Peritonsillar abscess (PTA) has a relatively high incidence of 41 per 100,000/year in Denmark. In spite of that, there is no regional or national consensus on treatment of PTA. Abscess drainage can be done by aspiration, incision or acute tonsillectomy. Several studies show that incision and aspiration are equally successful. The aim for this study is to compare aspiration to acute tonsillectomy (tonsillectomy a chaud) in a RCT study regarding sick-leave days, days of admission, pain, consumption of antibiotics, consumption of painkillers and patients´ self-assessed quality of life.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

2.1 years

First QC Date

March 15, 2017

Last Update Submit

November 8, 2017

Conditions

Peritonsillar Abscess

Keywords

TonsillectomyAspirationQuinsy

Outcome Measures

Primary Outcomes (1)

  • Number of sick-leave days

    Days away from job/education or other daily activities due to disease and treatment

    3 months

Secondary Outcomes (4)

  • Antibiotic consumption

    3 months

  • Painkiller consumption

    3 months

  • VAS score

    3 months

  • Quality of life and satisfaction with treatment measured by GBI

    3 months

Study Arms (2)

Needle aspiration

ACTIVE COMPARATOR

Patients treated with aspiration will receive standard antibiotic treatment according to clinical guidelines: Penicillin and metronidazole or Clindamycin alone in case of penicillin allergy. These patients will be treated in the outpatient clinic and will be examined again the day after inclusion. Aspiration will be done if necessary. At this first control visit the clinician will schedule the next visit based on findings.

Procedure: AspirationDrug: Penicillin V + metronidazol (Penicillin allergy: Clindamycin alone)

Tonsillectomy a chaud

ACTIVE COMPARATOR

Patients treated with tonsillectomy a chaud are admitted for intra-venous treatment with penicillin and metronidazole until surgery. Antibiotic treatment is discontinued after surgery and the patient may be discharged from the hospital the day after surgery.

Procedure: Tonsillectomy a chaud

Interventions

AspirationPROCEDURE

Needle aspiration of pus from the peritonsilar abscess

Also known as: Puncture
Needle aspiration
Tonsillectomy a chaudPROCEDURE

Removal of tonsil(s) due to peritonsillar abscess

Also known as: Tonsil removal
Tonsillectomy a chaud
Penicillin V + metronidazol (Penicillin allergy: Clindamycin alone)DRUG

patients treated with aspiration will receive antibiotic treatment

Needle aspiration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peritonsillar abscess

You may not qualify if:

  • respiratory distress
  • suspected malignancy
  • previous PTA
  • history of recurrent tonsillitis
  • patients with poor compliance to aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Peritonsillar Abscess

Interventions

PuncturesPenicillin VBenchmarking

Condition Hierarchy (Ancestors)

TonsillitisPharyngitisRespiratory Tract InfectionsInfectionsAbscessSuppurationPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, OperativePenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsManagement AuditOrganization and AdministrationHealth Services AdministrationProgram EvaluationQuality of Health CareQuality Assurance, Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation Mechanisms

Central Study Contacts

Daniel Skansing

CONTACT

+45 51932184Daniel.Brauner.Skansing3@rsyd.dk

Christian Heidemann

CONTACT

50937375chrheidemann@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
masking is not possible
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients randomized to treatment by needle aspiration or tonsillectomy a chaud
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 15, 2017

First Posted

October 31, 2017

Study Start

November 10, 2017

Primary Completion

November 30, 2019

Study Completion

November 30, 2020

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)