We want to compare the results and complications of surgery between traditional tonsillectomy and tonsillectomy by radiofrequency in adults suffering from chronic or recurrent tonsillitis. 60 patients older than 15 years old, suffering from recurrent episodes of tonsillitis referred to the ENT service in Rasht, Amiralmomenin hospital are randomly separated into two groups. One group underwent traditional tonsillectomy and the other was treated by Radiofrequency (RF).
Those with underlying bleeding disorders especially who had to use ASA or heparin were left out of the study.
Operation in the two groups was done under general anesthesia.
The manner how to perform the procedure and also the instruments used in the operating room, were similar in all patients. The tonsils were ablated near totally with especial probes.
A wide comparison between the two groups was done according to the followings:
The amount of bleeding during surgery; Duration of operation & anesthesia; Time of recovery; Pain-scale after surgery (especially in the 1st, 3rd, 5th & 10th days after surgery); Dysphagia; Date of rehabilitation; Date of taking routine diet; The patient's weight after surgery (especially in the 3rd -10th & 20th days after surgery); Complications such as post operation, bleeding, halitosis, snoring, frequency of tonsillitis & pharyngitis in the 6th & 12th & 15th months after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010091138N3
Registration date:2011-06-07, 1390/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-07, 1390/03/17
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Vice chancellor for Research
Expected recruitment start date
2008-04-08, 1387/01/20
Expected recruitment end date
2010-01-10, 1388/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The results of radiofrequency tonsillectomy compared with conventional cold dissection tonsillectomy in recovery of adults with recurrent tonsillitis.
Public title
Effect of radiofrequency tonsillectomy in recurrent tonsillitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
adult patients
(aged 15-65 years) with recurrent tonsillitis was performed
in a tertiary referral university hospital that candidated for surgery.
Exclusion criteria:
Those who had underlying bleeding disorders; who had to use ASA or heparin; those with immunologic disorders.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Guilan University of Medical Sciences
Street address
Siadati st.
City
Rasht
Postal code
Approval date
2007-06-10, 1386/03/20
Ethics committee reference number
1683
Health conditions studied
1
Description of health condition studied
Chronic Tonsillitis
ICD-10 code
J35.9
ICD-10 code description
Chronic disease of tonsils and adenoids
Primary outcomes
1
Description
postsurgical pain
Timepoint
on days 1, 3, 5 and 10 after surgery
Method of measurement
Visual Analogue Scale (VAS)
2
Description
recurrence of tonsillitis/pharyngitis episodes
Timepoint
on months 6, 12 and 15 after surgery
Method of measurement
ask from patient and periodic check-up
Secondary outcomes
1
Description
weight
Timepoint
in the 3rd, 10th and 20th days after surgery
Method of measurement
scale
2
Description
intraoperative bleeding
Timepoint
During and end of surgery
Method of measurement
measuring the blood volume in the vacuum bottle and also by counting the surgical gauzes
Intervention groups
1
Description
Surgery will be done under general anesthesia and the operation in control group will be done by standard method of cold dissection tonsillectomy (i.e. dissecting the palatal tonsils from their bed by surgical knife and separating and totally removal of the tonsils from their sites). Duration of operation is measured according to the time, when surgical field is exposed ( after accomplishing the anesthesia ) till the moment that the surgeon is sure that there is no bleeding in the field of operation.
At the end of the procedure, the amount of bleeding is estimated by measuring the blood volume in the vacuum bottle and also by counting the surgical gauzes, used in the operating room during surgery.
The pain scale after surgery is measured by Visual Analogue Scale from zero to ten centimeters in the 1st, 3rd, 5th and 10th days after surgery
The patients are asked about taking analgesia after surgery during the afore-mentioned days.
The patients are also asked about the frequency of tonsillitis & pharyngitis during previous months, and at the same time the faucial tonsils are compared with their pre operation condition according to their size in the 6th, 12th and 15th months after surgery.
Category
Treatment - Surgery
2
Description
With the patient under general anesthesia and in the Rose
position, the oropharynx was exposed by use of a Davis gag,
and bipolar-linear RFITT probe (Celon AG Medical Instruments,
Teltow/Berlin, Germany) was introduced into the
crypts of the tonsils. The RF generator working frequency
was 470 kHz, which was set at 7 W during the procedure.
The power was constantly controlled by the system, terminating
the energy application automatically once the thermal
lesion was created. Five points (i.e., tonsillar crypts,
including crypts of inferior and superior poles) for grades 1
and 2 tonsils, seven points for grade 3, and nine points for
grade 4 tonsils were probed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Shadman Nemati
Street address
17 shahrivar st.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Susan Komaii
Street address
Siadati st.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences, Vice Chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 shahrivar st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 shahrivar st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)