Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy (TONSIL)
Primary Purpose
Chronic Tonsillitis, Tonsillectomy, Tonsillar Hypertrophy
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tonsillectomy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Tonsillitis focused on measuring tonsillectomy, electrocautery, postoperative pain, visual analogue scale
Eligibility Criteria
Inclusion Criteria:
- 13-years old and older
- Informed consent
- Isolated tonsillectomy (without adenoidectomy, OSAS surgery etc )
- Tonsillar hypertrophy
Exclusion Criteria:
- Malignancy suspicion
- Additional simultaneous surgeries (adenoidectomy, OSAS etc)
Sites / Locations
- Gaziosmanpasa Taksim Research and Education Hospital, Department of OtorhinolaryngologyRecruiting
- Gaziosmanpasa Taksim Research and Education Hospital,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
COLD-DISSECTION
HOT-DISSECTION
Arm Description
Cold Dissection Technique
Needle Electrocautery Dissection Technique
Outcomes
Primary Outcome Measures
Change of postoperative Pain
Visual Analogue Scale will be used to evaluate the change in postoperative pain
Secondary Outcome Measures
Full Information
NCT ID
NCT02818647
First Posted
June 19, 2016
Last Updated
August 8, 2016
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02818647
Brief Title
Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy
Acronym
TONSIL
Official Title
Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients 13-years-or older who undergo tonsillectomy operation (without another additional surgery) will be enrolled in the study. Randomly, one side is going to be operated with conventional cold-knife technique and hemostasis will be maintained with bipolar diathermy (25-30w). Contralateral tonsil is going to be operated with needle-tip monopolar electrocautery (10-12w) at Blend 1 mode and hemostasis will also be maintained with needle-tip monopolar cautery. Postoperative tonsillar fossa healing and pain is going to be evaluated for both sides separately with Visual Analogue Scale. All operations are going to be performed by a single surgeon and all evaluations are going to be carried out by another surgeon in a totally blinded fashion to avoid possible bias.
Detailed Description
Comparison of cold and hot tonsillectomy carried out with needle-point tip monopolar electrocautery: a prospective, randomized, blinded, controlled (paired design) : A Randomized Clinical Trial
Tonsillectomy surgery techniques are basically divided into cold steel knife dissection and other (hot) techniques where surgeons use electrocautery and other contemporary technological devices. Pros / cons of hot and cold techniques have been long researched in the literature. Parameters are: cost, postoperative bleeding rate, postoperative pain. (Leinbach RF) Latest research proved that monopolar electrocautery (EC) is ideal when cost/postoperative bleeding rate ratio is concerned. (Cunningham LC) Although EC presents as a viable option, hot techniques - although providing good advantages - result with a more painful postoperative period. Trade-off with electrosurgery is the heat generated to cut/coagulate the tissue also causes a variable amount of tissue necrosis consequent to thermal injury. This pain is associated with the thermal injury and consequent tissue necrosis. (Hetzler D) Needle electrocautery tips are thinner compared to conventional bovie tip. Their surface area is smaller and according to the study carried out by Farnworth et al. (Farnworth TK) cause reduced thermal injury compared to conventional blade tip.
The investigators' aim in this study is to compare cold-knife dissection + bipolar diathermy tonsillectomy with needle tip EC monopolar cautery. Study design was prospective, randomised, single-blinded and controlled (paired). Either right tonsil was operated with standard-needle electrocautery, contralateral side was operated with cold-technique; or vice-versa. Which side received which treatment was randomly assigned (Aksoy F)
Surgical Technique
Both tonsils were injected with lidocaine and epinephrine infiltration to anterior tonsillar plica before the operation. All surgeries were performed by the primary investigator (BO) under x2.5 loupes. Force 2 Electrosurgical Generator (The Valley Lab, Boulder,CO) was used to power both the monopolar and bipolar electrocautery. Bipolar cautery was used (25-30 Watts) in accordance with the literature. Monopolar electrocautery settings were adjusted to 'Blend 1' which is a summation of the coagluation and cutting waveforms (75% cutting, 25% coagulation). Cut power was adjusted to 10W, whereas coagulation power was set to 12 Watts.
Results and Evaluations
Postoperative tonsillar fossa healing and pain is going to be evaluated for both sides separately with Visual Analogue Scale. All operations are going to be performed by a single investigator and all evaluations are going to be carried out by another investigator in a totally blinded fashion to avoid possible bias. These evaluations are going to be carried out for 10 postoperative days. Tonsillar fossa healing will be evaluated according to scale reported by Magdy EA et al. on first, fifth and tenth postoperative day (Magdy EA). Patients will evaluate their pain 10 (maximum) , 0 (none) based on a Visual Analogue Scale. Results will be calculated as (mean+-SD) and compared statistically for significance with SPSS.
Discussion
A finer tip can give greater precision in dissection and can also affect the dispersion characteristics of the energy used to perform the dissection. The implication of this for tonsillectomy is that greater precision in dissecting the tonsil from the underlying muscle can potentially lead to less post-operative discomfort.
For those surgeons who choose to use an electrocautery technique for tonsillectomy, the greater precision of the needle-tip EC may enhance the results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tonsillitis, Tonsillectomy, Tonsillar Hypertrophy
Keywords
tonsillectomy, electrocautery, postoperative pain, visual analogue scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COLD-DISSECTION
Arm Type
Active Comparator
Arm Description
Cold Dissection Technique
Arm Title
HOT-DISSECTION
Arm Type
Active Comparator
Arm Description
Needle Electrocautery Dissection Technique
Intervention Type
Procedure
Intervention Name(s)
Tonsillectomy
Intervention Description
Tonsillectomy is the name of the surgery where tonsils are removed via capsullary dissection. There are various techniques and its basically removing the tonsil from its tonsillary fossa and conducting hemostasis with various equipments.
Primary Outcome Measure Information:
Title
Change of postoperative Pain
Description
Visual Analogue Scale will be used to evaluate the change in postoperative pain
Time Frame
Postoperative first 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
13-years old and older
Informed consent
Isolated tonsillectomy (without adenoidectomy, OSAS surgery etc )
Tonsillar hypertrophy
Exclusion Criteria:
Malignancy suspicion
Additional simultaneous surgeries (adenoidectomy, OSAS etc)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berke özücer, MD
Phone
905309635939
Email
berkeozucer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet E Dinc, MD
Phone
905065426492
Email
dremredinc@hotmail.com
Facility Information:
Facility Name
Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology
City
Istanbul
State/Province
Gaziosmanpasa
ZIP/Postal Code
00000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berke Ozucer, MD
Phone
90-530-963-5939
Email
berkeozucer@gmail.com
First Name & Middle Initial & Last Name & Degree
Emre M Dinc, MD
Phone
905065426492
Email
dremredinc@hotmail.com
Facility Name
Gaziosmanpasa Taksim Research and Education Hospital,
City
Istanbul
ZIP/Postal Code
00000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berke Ozucer, MD
Phone
90-530-963-5939
Email
berkeozucer@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25304999
Citation
Cunningham LC, Chio EG. Comparison of outcomes and cost in patients undergoing tonsillectomy with electrocautery and thermal welding. Am J Otolaryngol. 2015 Jan-Feb;36(1):20-3. doi: 10.1016/j.amjoto.2014.08.016. Epub 2014 Sep 2.
Results Reference
background
PubMed Identifier
19943988
Citation
Aksoy F, Ozturan O, Veyseller B, Yildirim YS, Demirhan H. Comparison of radiofrequency and monopolar electrocautery tonsillectomy. J Laryngol Otol. 2010 Feb;124(2):180-4. doi: 10.1017/S0022215109991642. Epub 2009 Nov 30.
Results Reference
background
PubMed Identifier
8215134
Citation
Farnworth TK, Beals SP, Manwaring KH, Trepeta RW. Comparison of skin necrosis in rats by using a new microneedle electrocautery, standard-size needle electrocautery, and the Shaw hemostatic scalpel. Ann Plast Surg. 1993 Aug;31(2):164-7. doi: 10.1097/00000637-199308000-00016.
Results Reference
background
PubMed Identifier
8643267
Citation
Wexler DB. Recovery after tonsillectomy: electrodissection vs. sharp dissection techniques. Otolaryngol Head Neck Surg. 1996 Apr;114(4):576-81. doi: 10.1016/S0194-59989670249-8.
Results Reference
background
PubMed Identifier
14574289
Citation
Leinbach RF, Markwell SJ, Colliver JA, Lin SY. Hot versus cold tonsillectomy: a systematic review of the literature. Otolaryngol Head Neck Surg. 2003 Oct;129(4):360-4. doi: 10.1016/S0194-59980300729-0.
Results Reference
background
PubMed Identifier
20422706
Citation
Hetzler D. In reference to histologic assessment of thermal injury to tonsillectomy specimens: a comparison of electrocautery, coblation, harmonic scalpel, and tonsillotome. Laryngoscope. 2010 May;120(5):1077. doi: 10.1002/lary.20882. No abstract available.
Results Reference
background
PubMed Identifier
18036277
Citation
Magdy EA, Elwany S, el-Daly AS, Abdel-Hadi M, Morshedy MA. Coblation tonsillectomy: a prospective, double-blind, randomised, clinical and histopathological comparison with dissection-ligation, monopolar electrocautery and laser tonsillectomies. J Laryngol Otol. 2008 Mar;122(3):282-90. doi: 10.1017/S002221510700093X. Epub 2007 Nov 26.
Results Reference
background
Learn more about this trial
Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy
We'll reach out to this number within 24 hrs