TonsillitisNCT00636402
Study of Efficacy and Adverse Effects: Vessel Sealing System Tonsillectomy Versus Cold Knife Tonsillectomy
A study testing Cold Knife Tonsillectomy and Vessel Sealing System Tonsillectomy in people with Tonsillitis and Obstructive Sleep Apnea, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tonsillitis, Obstructive Sleep Apnea
- What is being tested?
- Cold Knife Tonsillectomy and Vessel Sealing System Tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2008to Dec 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea
- Written informed consent form is given from patient or patient's parents (in case of pediatric patient)
Who cannot join
- Pregnancy
- History of bleeding disorders
- Unilateral tonsillectomy
- Much difference in size of both tonsils (if the difference is more than or equal to 2, it will be defined as much different in size in this study)
- Patient unable to understand evaluation method
- Patient unable to be contacted via telephone
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Otolaryngology, King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, 10330
About this study
Official title: Vessel Sealing System Tonsillectomy vs Cold Knife Tonsillectomy: A Randomized, Paired Control Study of Efficacy and Adverse Effects
This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage.
Read the detailed description
Tonsillectomy is one of the most common procedures performed by otolaryngologists. Intraoperative bleeding is a significant problem which requires hemostasis and causes prolonged operative time. Several different techniques are used to perform this operation. Efficacy in hemostasis and tissue trauma from different operative techniques may result in different operative time and different degrees of morbidity including intraoperative blood loss, postoperative pain and hemorrhage.
The vessel sealing system has been widely used in head and neck surgery because of its effectiveness and safety. It was also found quite effective and safe in tonsillectomy procedures, providing excellent hemostasis and minimal tissue trauma. This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage.
Inclusion criteria are patients planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea and written informed consent form is given from patient or patient's parents (in case of pediatric patient).
Exclusion criteria are pregnancy, history of bleeding disorders, unilateral tonsillectomy, much different size of both tonsils (If the difference is more than or equal to 2, it will be defined as much different in size in this study), patient unable to understand evaluation method or unable to be contacted via telephone. Outcome measurements are the following.
- Operative time (minutes) will be started at the time of incision and ended at the time of complete hemostasis. After tonsillectomy on the first side is finished, 5-10 minutes is the lag time before tonsillectomy on the second side will be started in order to observe re-bleeding after operative time is recorded. If there is re-bleeding, the operative time will be changed and measured from the same starting time to the time of last complete hemostasis.
- Amount of blood loss (milliliter) will be measured from amount of fluid including blood and saliva in the container and gauze. Measurement will be started at the time of incision and ended at the time of complete hemostasis in the same manner of operative time.
- Pain score, postoperative hemorrhage or other adverse effects that the research assistant will record on post-op day 0-14 by using direct and telephone interview.
- Conditions
- Tonsillitis, Obstructive Sleep Apnea
- Being tested
- Cold Knife Tonsillectomy, Vessel Sealing System Tonsillectomy
- Keywords
- Vessel Sealing System, Cold Knife, Tonsillectomy, Pain, Postoperative
- Medical subject headings
- Tonsillitis, Sleep Apnea, Obstructive, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Knife TonsillectomyProcedure or surgery
Also called CKT
Cold Knife Tonsillectomy (CKT) will be done on the other side.
Vessel Sealing System TonsillectomyProcedure or surgery
Also called VSST
Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vessel Sealing System Tonsillectomy (VSST) Receives: Procedure: Vessel Sealing System Tonsillectomy |
| 2 | Active comparator | Cold Knife Tonsillectomy (CKT) Receives: Procedure: Cold Knife Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative time
Measured: 1 day
Intra-operative blood loss
Measured: 1 day
Pain, postoperative
Measured: 14 days
Secondary outcomes (1)
Postoperative bleeding and other adverse effects
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Prakobkiat Hirunwiwatkul, M.D., Principal investigator, Faculty of Medicine, Chulalongkorn University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636402
- Sponsor's protocol ID
- ENTCU_pkk2008_01
- Status last verified
- Dec 2008
- First submitted
- 7 Mar 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lachanas VA, Hajiioannou JK, Karatzias GT, Filios D, Koutsias S, Mourgelas C. Comparison of LigaSure vessel sealing system, harmonic scalpel, and cold knife tonsillectomy. Otolaryngol Head Neck Surg. 2007 Sep;137(3):385-9. doi: 10.1016/j.otohns.2007.05.012.
PubMed 17765762Lachanas VA, Prokopakis EP, Bourolias CA, Karatzanis AD, Malandrakis SG, Helidonis ES, Velegrakis GA. Ligasure versus cold knife tonsillectomy. Laryngoscope. 2005 Sep;115(9):1591-4. doi: 10.1097/01.mlg.0000172044.57285.b6.
PubMed 16148700Prokopakis EP, Lachanas VA, Benakis AA, Helidonis ES, Velegrakis GA. Tonsillectomy using the Ligasure vessel sealing system. A preliminary report. Int J Pediatr Otorhinolaryngol. 2005 Sep;69(9):1183-6. doi: 10.1016/j.ijporl.2005.03.042.
PubMed 15961165Lister MT, Cunningham MJ, Benjamin B, Williams M, Tirrell A, Schaumberg DA, Hartnick CJ. Microdebrider tonsillotomy vs electrosurgical tonsillectomy: a randomized, double-blind, paired control study of postoperative pain. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):599-604. doi: 10.1001/archotol.132.6.599.
PubMed 16785404Newman CJ, Lolekha R, Limkittikul K, Luangxay K, Chotpitayasunondh T, Chanthavanich P. A comparison of pain scales in Thai children. Arch Dis Child. 2005 Mar;90(3):269-70. doi: 10.1136/adc.2003.044404.
PubMed 15723913
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vessel Sealing System Tonsillectomy vs Cold Knife Tonsillectomy: A Randomized, Paired Control Study of Efficacy and Adverse Effects
- ClinicalTrials.gov ID
- NCT00636402
- Acronym / sponsor ID
- ENTCU_pkk2008_01
- Conditions
- Tonsillitis, Obstructive Sleep Apnea
- Keywords
- Vessel Sealing System, Cold Knife, Tonsillectomy, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 14 Mar 2008 (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.
This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage.
Detailed description
Tonsillectomy is one of the most common procedures performed by otolaryngologists. Intraoperative bleeding is a significant problem which requires hemostasis and causes prolonged operative time. Several different techniques are used to perform this operation. Efficacy in hemostasis and tissue trauma from different operative techniques may result in different operative time and different degrees of morbidity including intraoperative blood loss, postoperative pain and hemorrhage.
The vessel sealing system has been widely used in head and neck surgery because of its effectiveness and safety. It was also found quite effective and safe in tonsillectomy procedures, providing excellent hemostasis and minimal tissue trauma. This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage.
Inclusion criteria are patients planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea and written informed consent form is given from patient or patient's parents (in case of pediatric patient).
Exclusion criteria are pregnancy, history of bleeding disorders, unilateral tonsillectomy, much different size of both tonsils (If the difference is more than or equal to 2, it will be defined as much different in size in this study), patient unable to understand evaluation method or unable to be contacted via telephone. Outcome measurements are the following.
- Operative time (minutes) will be started at the time of incision and ended at the time of complete hemostasis. After tonsillectomy on the first side is finished, 5-10 minutes is the lag time before tonsillectomy on the second side will be started in order to observe re-bleeding after operative time is recorded. If there is re-bleeding, the operative time will be changed and measured from the same starting time to the time of last complete hemostasis.
- Amount of blood loss (milliliter) will be measured from amount of fluid including blood and saliva in the container and gauze. Measurement will be started at the time of incision and ended at the time of complete hemostasis in the same manner of operative time.
- Pain score, postoperative hemorrhage or other adverse effects that the research assistant will record on post-op day 0-14 by using direct and telephone interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Vessel Sealing System TonsillectomyVessel Sealing System Tonsillectomy (VSST) |
| 2 | Active comparator | Procedure: Cold Knife TonsillectomyCold Knife Tonsillectomy (CKT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea
- Written informed consent form is given from patient or patient's parents (in case of pediatric patient)
Key exclusion criteria (6 listed)
- Pregnancy
- History of bleeding disorders
- Unilateral tonsillectomy
- Much difference in size of both tonsils (if the difference is more than or equal to 2, it will be defined as much different in size in this study)
- Patient unable to understand evaluation method
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 |
|---|---|---|
| Cold Knife TonsillectomyAlso: CKTCold Knife Tonsillectomy (CKT) will be done on the other side. | Procedure or surgery | 2 |
| Vessel Sealing System TonsillectomyAlso: VSSTIntervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side. | Procedure or surgery | 1 |
Primary outcome
Intra-operative time
Time frame: 1 day
Intra-operative blood loss
Time frame: 1 day
Pain, postoperative
Time frame: 14 days
1 secondary outcome
Postoperative bleeding and other adverse effects
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2008.
- Results publication: PubMed 17765762Lachanas VA, Hajiioannou JK, Karatzias GT, Filios D, Koutsias S, Mourgelas C. Comparison of LigaSure vessel sealing system, harmonic scalpel, and cold knife tonsillectomy. Otolaryngol Head Neck Surg. 2007 Sep;137(3):385-9. doi: 10.1016/j.otohns.2007.05.012.
- Results publication: PubMed 16148700Lachanas VA, Prokopakis EP, Bourolias CA, Karatzanis AD, Malandrakis SG, Helidonis ES, Velegrakis GA. Ligasure versus cold knife tonsillectomy. Laryngoscope. 2005 Sep;115(9):1591-4. doi: 10.1097/01.mlg.0000172044.57285.b6.
- Results publication: PubMed 15961165Prokopakis EP, Lachanas VA, Benakis AA, Helidonis ES, Velegrakis GA. Tonsillectomy using the Ligasure vessel sealing system. A preliminary report. Int J Pediatr Otorhinolaryngol. 2005 Sep;69(9):1183-6. doi: 10.1016/j.ijporl.2005.03.042.
- Results publication: PubMed 16785404Lister MT, Cunningham MJ, Benjamin B, Williams M, Tirrell A, Schaumberg DA, Hartnick CJ. Microdebrider tonsillotomy vs electrosurgical tonsillectomy: a randomized, double-blind, paired control study of postoperative pain. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):599-604. doi: 10.1001/archotol.132.6.599.
- Results publication: PubMed 15723913Newman CJ, Lolekha R, Limkittikul K, Luangxay K, Chotpitayasunondh T, Chanthavanich P. A comparison of pain scales in Thai children. Arch Dis Child. 2005 Mar;90(3):269-70. doi: 10.1136/adc.2003.044404.
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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.
Prakobkiat Hirunwiwatkul, M.D. principal investigator
Faculty of Medicine, Chulalongkorn University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Knife Tonsillectomy and Vessel Sealing System Tonsillectomy in people with Tonsillitis and Obstructive Sleep Apnea, run by Chulalongkorn University at 1 site in Thailand.
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 2 inclusion and 6 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 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative time (time frame: 1 day). The study lists 3 primary outcomes in all. 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 NCT00636402, which also lists 5 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 11 Dec 2008.