Incision in local anesthesia or operative removal of the tonsil to drain a collection of pus beside the tonsil (peritonsillar abscess)
| ISRCTN | ISRCTN81718286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81718286 |
| Secondary identifying numbers | 15/9/15 |
- Submission date
- 18/04/2016
- Registration date
- 07/06/2016
- Last edited
- 24/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
A peritonsillar abscess, also known as quinsy, is a rare and potentially life-threatening complication of tonsillitis. It happens when an abscess (collection of pus) forms between one of the tonsils and the wall of the throat, causing pain, swelling and difficulty swallowing. For many patients, surgical treatment may be necessary in order to prevent further serious complications, such as blocked airways, lung infections or rupture (bursting) of the abscess. Most often, a small cut (incision) is made over the infected area so that the pus can be drained (incision and drainage procedure), although in some cases, the tonsils themselves are removed (tonsillectomy). Of these two procedures, it is unclear as to which is the most effective, in terms of pain relief, improvement on quality of life, time until recovery and recurrence (return) of the infection. The aim of this study is to compare these factors in patients receiving the incision and drainage, and tonsillectomy procedures.
Who can participate?
Adults with a peritonsillar abscess.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo the incision and drainage procedure under local anaesthetic (numbing injection). Those in the second group undergo a tonsillectomy while they are under a general anaesthetic (unconscious). After undergoing the procedures, participants in both groups remain in hospital for 5 days for observation. Before the procedure, participants are asked to score their level of pain, at rest and when swallowing, and then immediately after the procedure to judge their level of pain relief. Participants are asked about their pain levels every two hours the day after the procedure, and every three hours for the rest of their hospital stay. These questions are then repeated after one and six months.
What are the possible benefits and risks of participating?
There is no direct benefit from taking part in the study because all medical care provided is standard at the hospital. There are no notable risks other than the general risks involved with undergoing the procedures involved in the study, such as bleeding, pain, or allergy to antibiotics.
Where is the study run from?
University Medical Center Göttingen (Germany)
When is the study starting and how long is it expected to run for?
May 2015 to June 2024
Who is funding the study?
University Medical Center Göttingen (Germany)
Who is the main contact?
Dr Bernhard Weiss
Contact information
Scientific
Department of Otorhinolaryngology
University Hospital, Ludwig-Maximilians-University, Munich, Germany
Marchioninistr. 15
Munich
81377
Germany
 ORCID ID |
0000-0002-8368-0149 |
|---|
Study information
| Study design | Prospective randomized controlled single-centre interventional clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Incision and Drainage or tonsillectomy for Treatment of PeriTonsillar Abscess: A prospective randomized clinical trial |
| Study acronym | IDTPTA |
| Study objectives | Peritonsillar abscess treated by tonsillectomy is superior to incision and drainage in local anesthesia in subjective experience of peri- and postinterventional pain and is followed by increased patient satisfaction. |
| Ethics approval(s) | Ethik-Kommission der Universitätsmedizin Göttingen, 04/01/2016, ref: 15/9/15 |
| Health condition(s) or problem(s) studied | Peritonsillar abscess |
| Intervention | Participants are randomly allocated to one of two groups using consecutively numbered envelopes including the decision for the treatment strategy. Group 1: Participants receive the incision and drainage procedure which is performed under local anesthesia following an IV application of 1 g paracetamol. The patient lies in a 45° erected upper body. The mucosa will be anaesthetized superficially by lidocaine spray. After 3-5 minutes lidocaine will be injected at the maximum of mucosa protrusion for further local anesthesia. Following this, the abscess will be identified by punction with a 20 G needle. In case of pus aspiration an incision will be performed by scalpel, subsequently enlarged and opened using Hartmann’s forceps and the cavity completely emptied with the Eicken’s aspirator. The duration for this intervention is approximately 20 minutes. Group 2: Participants receive a tonsillectomy, which is performed in an extracapsular approach in balanced total anesthesia. The patient lies in supine position with the neck extended dorsaly. After applying McIvar’s mouth gag the tonsil will be luxated and the tonsil capsule identified with surgical scissors cutting the mucosa and spreading the tissue gently. Thoroughly following the capsule the tonsil is dissected out of its bed to thereby open up the abscess cavity. Anesthesia ends with applying 100 mg diclofenac suppository. The duration for this intervention is approximately 20 minutes. After intervention, patients stay in hospital for five days for observation and i.v. application of antibiotics. After discharge from the hospital follow-up visits will be 1 and 6 month after intervention. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain is measured using the numeric rating scale (pain in rest, pain during swallowing) and the visual analogue scale (pain relief by intervention) at baseline before intervention (pain in rest, pain during swallowing) and directly after intervention (pain in rest, pain during swallowing and pain relief by intervention). Afterwards at the day of intervention the two questions to measure pain (pain in rest, pain during swallowing) are asked every 2 hours as well as 30 minutes before and 60 minutes after taking pain medication. From the first day after intervention on, the two questions are asked every 3 hours as well as before and after taking pain medication, and at 1 and 6 months. |
| Secondary outcome measures | 1. Patient satisfaction is measured using the visual analogue scale (VAS) directly after intervention, at first day after intervention and before discharge 2. Required pain medication is measured by reviewing the records of the nursing team that regularly documents analgetics given to the patients 3. Trismus is measured using a metric tape measure at baseline before intervention and every day after during the hospital stay 4. Temperature is measured using a medical thermometer at baseline before intervention and every day after during the hospital stay 5. Inflammation is measured by white blood cells (WBC) and C-reactive protein (CRP) laboratory tests at baseline before intervention, at the second day after intervention and before discharge 6. Rate on pus drainage, required number of punctures and incisions, residual abscesses is measured during intervention and during follow up at hospital stay if re-interventions would be necessary 7. Complication rate is measured by documentation of all specific incidents occurring during hospital stay. When patients are seen for follow up at 1 and 6 month they are asked for the occurrence of special incidents 8. Specific (TOI-14) and general (15D) health related quality of life are measured using the Tonsillectomy Outcome Inventory 14 and the 15D-questionaire. The TOI-14 questionnaire is given to the patient at baseline and at 6 month follow up visit. The 15D questionnaire is given to the patient at baseline, the day after intervention, before discharge and at 1 and 6 month follow up visit. 9. Patient's benefit from otorhinolaryngological surgery and therapy is measured using the Glasgow Benefit Inventory at the 1 month follow up visit 10. Length of hospital stay is measured by prospective documentation 11. Time to full recovery and to resume work is measured using a response letter that is handed to the patient at discharge from hospital 12. Rate of recurrent tonsillitis, peritonsillar abscesses or two-stage tonsillectomy is measured by asking for this incidents at follow up visits 1 and 6 month after intervention 13. Microbial spectrum is measured using microbial swab sampling of the pus during drainage of the abscess |
| Overall study start date | 25/05/2015 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 patients |
| Key inclusion criteria | 1. Aged between 18 and 65 years 2. Peritonsillar abscess 3. Informed consent |
| Key exclusion criteria | 1. Absence of informed consent 2. Secondary diagnosis that require regular analgetic medication 3. Psychiatric disorders (e.g. somatization disorder and affective disorders) 4. Pregnancy and breastfeeding 5. Chronic renal and liver disease 6. Gastric ulcer 7. Bone marrow diseases and diseases of the haematopoetic system 8. Medication of acetylsalicylic acid, coumarin derivatives or other anticoagulant medication in the last 10 days 9. Severe secondary diagnosis that go along with increased risk for general anesthesia 10. Limited cooperation or trismus severity that make Incision and drainage in local anesthesia impossible |
| Date of first enrolment | 08/06/2016 |
| Date of final enrolment | 13/11/2022 |
Locations
Countries of recruitment
- Germany
Study participating centre
Marchioninistr. 15
Munich
81377
Germany
Sponsor information
Hospital/treatment centre
Robert-Koch-Str. 40
Göttingen
37075
Germany
"ROR" |
https://ror.org/021ft0n22 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Planned publication of data after recruitment, analysis and paper work in peer reviewed journals 2. Planned presentation of data at scientific conferences |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
24/07/2023: The recruitment end date was changed from 31/12/2023 to 13/11/2022.
14/11/2022: The following changes have been made:
1. The recruitment end date has been changed from 15/05/2018 to 31/12/2023.
2. The overall trial end date has been changed from 15/11/2018 to 30/06/2024 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/12/2018 to 31/12/2024.
24/10/2022: The following changes have been made:
1. The scientific contact's details have changed.
2. University Medical Center Göttingen has been removed from the trial participating centres and Ludwig-Maximilians-University Hospital added.
