Chronic TonsillitisTONSILNCT02818647
Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy
A study testing Tonsillectomy in people with Chronic Tonsillitis and Tonsillectomy, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Chronic Tonsillitis, Tonsillectomy, Tonsillar Hypertrophy
- What is being tested?
- Tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jun 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 13-years old and older
- Informed consent
- Isolated tonsillectomy (without adenoidectomy, OSAS surgery etc )
- Tonsillar hypertrophy
Who cannot join
- Malignancy suspicion
- Additional simultaneous surgeries (adenoidectomy, OSAS etc)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology
Istanbul, Gaziosmanpasa, 00000
Berke Ozucer, MD, 90-530-963-5939, berkeozucer@gmail.com
Emre M Dinc, MD, 905065426492, dremredinc@hotmail.com
- Recruiting
Gaziosmanpasa Taksim Research and Education Hospital,
Istanbul, Istanbul, 00000
Berke Ozucer, MD, 90-530-963-5939, berkeozucer@gmail.com
About this study
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.
Read the 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.
- Conditions
- Chronic Tonsillitis, Tonsillectomy, Tonsillar Hypertrophy
- Being tested
- Tonsillectomy
- Keywords
- tonsillectomy, electrocautery, postoperative pain, visual analogue scale
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| COLD-DISSECTION | Active comparator | Cold Dissection Technique Receives: Procedure: Tonsillectomy |
| HOT-DISSECTION | Active comparator | Needle Electrocautery Dissection Technique Receives: Procedure: Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of postoperative Pain
Visual Analogue Scale will be used to evaluate the change in postoperative pain
Measured: Postoperative first 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berke Ozucer, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818647
- Sponsor's protocol ID
- TONSIL
- Acronym
- TONSIL
- Status last verified
- Aug 2016
- First submitted
- 19 Jun 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25304999Aksoy 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.
PubMed 19943988Farnworth 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.
PubMed 8215134Wexler 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.
PubMed 8643267Leinbach 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.
PubMed 14574289Hetzler 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.
PubMed 20422706Magdy 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.
PubMed 18036277
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cold Dissection Technique and Needle Monopolar Electrocautery Tonsillectomy
- ClinicalTrials.gov ID
- NCT02818647
- Acronym / sponsor ID
- TONSIL / TONSIL
- Conditions
- Chronic Tonsillitis, Tonsillectomy, Tonsillar Hypertrophy
- Keywords
- tonsillectomy, electrocautery, postoperative pain, visual analogue scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COLD-DISSECTION | Active comparator | Procedure: TonsillectomyCold Dissection Technique |
| HOT-DISSECTION | Active comparator | Procedure: TonsillectomyNeedle Electrocautery Dissection Technique |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 13-years old and older
- Informed consent
- Isolated tonsillectomy (without adenoidectomy, OSAS surgery etc )
- Tonsillar hypertrophy
Key exclusion criteria (2 listed)
- Malignancy suspicion
- Additional simultaneous surgeries (adenoidectomy, OSAS etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TonsillectomyTonsillectomy 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. | Procedure or surgery | COLD-DISSECTION, HOT-DISSECTION |
Primary outcome
Change of postoperative Pain
Time frame: Postoperative first 10 days
Visual Analogue Scale will be used to evaluate the change in postoperative pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Background: PubMed 25304999Cunningham 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.
- Background: PubMed 19943988Aksoy 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.
- Background: PubMed 8215134Farnworth 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.
- Background: PubMed 8643267Wexler 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.
- Background: PubMed 14574289Leinbach 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.
- Background: PubMed 20422706Hetzler 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.
- Background: PubMed 18036277Magdy 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.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Tonsillitis
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A Comparative Study of Monopolar Versus Bipolar Electrocautery Post Tonsillectomy Outcomes.
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Active, not recruiting
Intracapsular Tonsillectomy in Adults
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The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsillectomy in people with Chronic Tonsillitis and Tonsillectomy, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berke özücer, MD (905309635939, berkeozucer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of postoperative Pain (time frame: Postoperative first 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818647, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.