Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy
TONSIL
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 19, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedAugust 9, 2016
August 1, 2016
6 months
June 19, 2016
August 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of postoperative Pain
Visual Analogue Scale will be used to evaluate the change in postoperative pain
Postoperative first 10 days
Study Arms (2)
COLD-DISSECTION
ACTIVE COMPARATORCold Dissection Technique
HOT-DISSECTION
ACTIVE COMPARATORNeedle Electrocautery Dissection Technique
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old and older
- Informed consent
- Isolated tonsillectomy (without adenoidectomy, OSAS surgery etc )
- Tonsillar hypertrophy
You may not qualify if:
- Malignancy suspicion
- Additional simultaneous surgeries (adenoidectomy, OSAS etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology
Istanbul, Gaziosmanpasa, 00000, Turkey (Türkiye)
Gaziosmanpasa Taksim Research and Education Hospital,
Istanbul, Istanbul, 00000, Turkey (Türkiye)
Related Publications (7)
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.
PMID: 25304999BACKGROUNDAksoy 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.
PMID: 19943988BACKGROUNDFarnworth 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.
PMID: 8215134BACKGROUNDWexler 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.
PMID: 8643267BACKGROUNDLeinbach 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.
PMID: 14574289BACKGROUNDHetzler 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.
PMID: 20422706BACKGROUNDMagdy 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.
PMID: 18036277BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Otolaryngologist, Medical Doctor
Study Record Dates
First Submitted
June 19, 2016
First Posted
June 30, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
August 9, 2016
Record last verified: 2016-08