- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457619
Coblation Tonsillectomy Versus Cold Dissection Tonsillectomy
Comparison of the Outcome of Coblation Tonsillectomy Versus Cold Dissection Tonsillectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design: Randomized Controlled Trial Setting: Department of Otorhinolaryngology, Sheikh Zayed Hospital, Lahore. Sample size With a 95% confidence level, 80% study power, and a mean pain score of 1.84 ± 0.85 for the cold dissection group and 1.24 ± 0.77 for the coblation group, the sample size of 60 cases-30 in each group-is determined.8 Sampling Technique Non-probability, consecutive sampling.
DATA COLLECTION PROCEDURE:
A total of 60 patients admitted to the otorhinolaryngology department of Sheikh Zayed Hospital in Lahore will be chosen following approval by the CPSP and the institutional ethical review committee. Every patient will be asked for their informed permission. All demographic data, including age, gender, and length of illness, will then be recorded. Every chosen case will be given the opportunity to select a slip from the total number of mixed-up slips (half-slips will include the letter "A," and other half-slips will contain the letter "B"), and they will be assigned to the appropriate group. Patients in group A will have their tonsils removed by coblation, and those in group B will have their tonsils removed by cold dissection. With the help of the researcher, a single surgical team will do every procedure. Using curved Metzenbaum scissors to penetrate the peritonsillar area, blunt dissection to remove the tonsil from superior to inferior, and a wire snare to separate the inferior pole, a cold dissection tonsillectomy will be carried out. At a setting of 35, a bipolar cautery will be used to achieve hemostasis. Using subcapsular dissection along the tonsillar pillar mucosa, the EVAC70 T&A (ArthroCare ENT, Sunnyvale, CA) hand piece will execute the coblation-assisted tonsillectomy while preserving muscle. Hemostasis will be achieved on the coagulate 3 setting, and dissection will be performed on the coagulate 7 setting. All patients will receive the same anesthesia and recovery room procedures. As stated in the operational definition, postoperative pain score, primary, reactionary and secondary hemorrhage will be recorded. Pre-designed Performa will be used to gather the data (Annexure I).
DATA ANALYSIS:
SPSS version 25.0 will be used to enter and evaluate the data. The data's normality will be examined using the Shapiro-Wilk test. For age, duration of illness and postoperative pain score, the mean and SD or median (IQR) will be displayed. For gender, place of residence (rural vs. urban), primary, reactionary and secondary hemorrhage, frequency and percentage will be displayed. The independent "t" test will be used to compare the postoperative pain in both groups and chi square test for primary, reactionary and secondary hemorrhage; a p-value of less than 0.05 will be considered significant. Age, gender, length of illness, and residence (rural vs. urban) will all be stratified. The independent 't' test will be used after stratification, and a p-value of less than 0.05 will be regarded as significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bahawalpur, Pakistan
- Shaikh Zayed Hospital, Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• All patients with chronic tonsillitis (as per-operational definition) of duration >3 months
Exclusion Criteria:
- History of peritonsillar abscess.
- Patients with known bleeding disorder (INR >1.5).
- Patients with tonsillar malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: coblation tonsillectomy
|
Using subcapsular dissection along the tonsillar pillar mucosa, the EVAC70 T&A (ArthroCare ENT, Sunnyvale, CA) hand piece will execute the coblation-assisted tonsillectomy while preserving muscle.
Hemostasis will be achieved on the coagulate 3 setting, and dissection will be performed on the coagulate 7 setting.
|
|
Active Comparator: cold dissection tonsillectomy
|
Using curved Metzenbaum scissors to penetrate the peritonsillar area, blunt dissection to remove the tonsil from superior to inferior, and a wire snare to separate the inferior pole, a cold dissection tonsillectomy will be carried out.
At a setting of 35, a bipolar cautery will be used to achieve hemostasis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Secondary infection
Time Frame: 2 weeks
|
presence of purulent discharge (thick and milky discharge from a wound) and resulting in opening of the skin wound
|
2 weeks
|
|
Incidence of post-operative pain
Time Frame: one week
|
measured using a visual analoque scale 7 days after the procedure, with 0 representing no pain and 10 representing the severe pain
|
one week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SZH, Lahore
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tonsillitis
-
Turku University HospitalNot yet recruitingChronic Tonsillitis | Recurrent Tonsillitis
-
Indus Hospital and Health NetworkActive, not recruitingChronic TonsillitisPakistan
-
Liaquat University of Medical & Health SciencesUniversity of Urbino "Carlo Bo"Recruiting
-
Aarhus University HospitalSkodstrup Medical Clinic, DenmarkUnknownStreptococcal Acute TonsillitisDenmark
-
Oulu University HospitalCompletedTonsillitis Chronic | Tonsillitis RecurrentFinland
-
Turku University HospitalActive, not recruitingTonsillitis | Tonsillitis Chronic | Tonsil Disease | Tonsillitis AcuteFinland
-
Kafrelsheikh UniversityCompletedChronic TonsillitisEgypt
-
Assiut UniversityUnknownAcute Follicular Tonsillitis
-
China Academy of Chinese Medical SciencesBeijing Chao Yang Hospital; The First Affiliated Hospital of Henan University... and other collaboratorsUnknownAcute Tonsillitis
-
Combined Military Hospital, PakistanCompleted
Clinical Trials on coblation tonsillectomy
-
Kaiser PermanenteWithdrawnObstructive Sleep Apnea | Tonsillitis | Adenotonsillar Hypertrophy
-
University of CalgaryArthroCare Corporation; Calgary Health RegionUnknownObstructive Sleep ApneaCanada
-
Kafrelsheikh UniversityCompletedChronic TonsillitisEgypt
-
Hillel Yaffe Medical CenterUnknownChronic Tonsillitis
-
Turku University HospitalNot yet recruitingChronic Tonsillitis | Recurrent Tonsillitis
-
University of CalgaryRecruiting
-
Centre Francois BaclesseRecruitingCancer of Head and Neck | AdenopathyFrance
-
Hillel Yaffe Medical CenterUnknownSleep Apnea, Obstructive
-
Hillel Yaffe Medical CenterUnknown