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Trial record 18 of 18 for:    Recruiting, Not yet recruiting, Available Studies | "Tonsillitis"

Peritonsillar Abscess: Aspiration Versus Tonsillectomy a Chaud

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ClinicalTrials.gov Identifier: NCT03326661
Recruitment Status : Not yet recruiting
First Posted : October 31, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Christian Heidemann, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Peritonsillar Abscess Procedure: Aspiration Procedure: Tonsillectomy a chaud Drug: Penicillin V + metronidazol (Penicillin allergy: Clindamycin alone) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients randomized to treatment by needle aspiration or tonsillectomy a chaud
Masking: None (Open Label)
Masking Description: masking is not possible
Primary Purpose: Treatment
Official Title: Peritonsillar Abscess: Aspiration Versus Tonsillectomy a Chaud
Estimated Study Start Date : November 10, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Tonsillitis

Arm Intervention/treatment
Active Comparator: Needle aspiration
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: Aspiration
Needle aspiration of pus from the peritonsilar abscess
Other Name: Puncture

Drug: Penicillin V + metronidazol (Penicillin allergy: Clindamycin alone)
patients treated with aspiration will receive antibiotic treatment

Active Comparator: Tonsillectomy a chaud
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
Removal of tonsil(s) due to peritonsillar abscess
Other Name: Tonsil removal




Primary Outcome Measures :
  1. Number of sick-leave days [ Time Frame: 3 months ]
    Days away from job/education or other daily activities due to disease and treatment


Secondary Outcome Measures :
  1. Antibiotic consumption [ Time Frame: 3 months ]
    number of days with antibiotic treatment

  2. Painkiller consumption [ Time Frame: 3 months ]
    number of days with painkillers necessary

  3. VAS score [ Time Frame: 3 months ]
    pain score

  4. Quality of life and satisfaction with treatment measured by GBI [ Time Frame: 3 months ]
    patient reported outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Peritonsillar abscess

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326661


Contacts
Contact: Daniel Skansing +45 51932184 Daniel.Brauner.Skansing3@rsyd.dk
Contact: Christian Heidemann 50937375 chrheidemann@gmail.com

Locations
Denmark
Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Daniel Skansing    +45 51932184    Daniel.Brauner.Skansing3@rsyd.dk   
Contact: Christian Heidemann    50937375    chrheidemann@gmail.com   
Sponsors and Collaborators
Odense University Hospital

Responsible Party: Christian Heidemann, Principal investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03326661     History of Changes
Other Study ID Numbers: 15/42959
S-20150156 ( Other Identifier: The Regional Committees on Health Research Ethics for Southern Denmark )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christian Heidemann, Odense University Hospital:
Tonsillectomy
Aspiration
Quinsy

Additional relevant MeSH terms:
Tonsillitis
Abscess
Peritonsillar Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Penicillins
Penicillin V
Metronidazole
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents