Neck DissectionNCT00875953
Use of the Harmonic Scalpel in Neck Dissection
A study testing standard neck dissection and Harmonic Scalpel Dissection in people with Neck Dissection, run by University of Calgary at 1 site in Canada.
Trial summary
Neck dissection is the main technique used by head and neck surgeons to treat known or suspected metastatic cancer to the neck. The traditional radical neck dissection was effective at treating metastatic cancer to the neck however the downside to this technique was significant morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Dissection
- What is being tested?
- standard neck dissection and Harmonic Scalpel Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- undergoing neck dissection (levels I-IV)
Who cannot join
- no prior head and neck surgery
- no prior head and neck cancer
- no prior head and neck radiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harmonic Scalpel vs. Electrocautery in Modified Radical Neck Dissection: A Single Blinded Prospective Randomized Trial
Neck dissection is the main technique used by head and neck surgeons to treat known or suspected metastatic cancer to the neck. The traditional radical neck dissection was effective at treating metastatic cancer to the neck however the downside to this technique was significant morbidity. Since the early 1960's there has been several proposed techniques to treat metastatic head and neck cancer that involves preserving important anatomical structures in the neck. The disadvantage to these techniques are that they require meticulous dissection and can lead to bleeding and an increase in operative time. One particular tool that has been proposed in other surgical subspecialties, including head and neck surgery, is the harmonic scalpel. Using this tool, tissue dissection and vessel occlusion at the same time can occur with a reduced thermal damage to the surrounding tissue when compared to traditional cautery. In this study, our purpose is to determine if the harmonic scalpel will lead to a decrease in blood loss and operative time in patients undergoing a modified radical neck dissection compared to electrocautery.
Hypothesis: Use of the harmonic scalpel as a surgical adjunct will reduce operative time for neck dissection and will reduce intraoperative blood loss.
Read the detailed description
Patients who are referred to either the clinic of Dr. Joseph Dort or Dr. Wayne Matthews and are deemed to benefit from a modified radical neck dissection alone or as part of treatment for head and neck cancer will be given an opportunity to be a subject in this study. Once informed consent for both the surgery and the study is obtained, the lead author will be contacted and randomization will occur using a computer generated block-randomization allocation. The neck dissection will be carried out in the operating room using either electrocautery (control group) or harmonic scalpel (experimental group). The primary outcomes, blood loss (mLs) and operative time (minutes) will be assessed at the time of surgery. The blood loss in milliliters will be calculated using suction canister output, weight of sponges and irrigation used. The operative time in minutes will be calculated between the beginning of the actual neck dissection to the completion of the neck dissection defined as the removal of the surgical specimen and hemostasis of the surgical field. Intraoperative complications, namely vascular, nerve damage and lymphatic damage will be assessed at the time of surgery. Post-operative complications, both early and late will be assessed after the surgery using the Clavien post-operative complication scale. In addition, the length of time that operative drains are left in the neck will be measured with all drains being removed when their 24 hour drain output is less than 20 mls. Patients will then be followed up 2 weeks after their hospital discharge in the surgeon's clinic or the Tom Baker Cancer Centre.
- Conditions
- Neck Dissection
- Being tested
- standard neck dissection, Harmonic Scalpel Dissection
- Keywords
- squamous cell carcinoma, head and neck cancer, neck dissection
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard neck dissectionProcedure or surgery
standard surgical technique
Harmonic Scalpel DissectionProcedure or surgery
Also called ethicon harmonic scalpel used
harmonic scalpel used for neck dissection after flaps are raised.
| Study group | Role | What they receive |
|---|---|---|
| Standard dissection | Active comparator | standard neck dissection technique: scalpel and cautery. Receives: Procedure: standard neck dissection |
| Harmonic Scalpel | Experimental | Harmonic scalpel used in neck dissection. Receives: Procedure: Harmonic Scalpel Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative blood loss
Measured: intraoperative
Operating Time
Measured: at end of the procedure
Secondary outcomes (2)
wound drainage
Measured: 48 hours
wound infection
Measured: 48 hours, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck DissectionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Joseph C Dort, BSc, MSc, MD, Principal investigator, University of Calgary - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875953
- Sponsor's protocol ID
- UCENT003
- Status last verified
- Apr 2009
- First submitted
- 3 Apr 2009
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonic Scalpel vs. Electrocautery in Modified Radical Neck Dissection: A Single Blinded Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00875953
- Acronym / sponsor ID
- UCENT003
- Conditions
- Neck Dissection
- Keywords
- squamous cell carcinoma, head and neck cancer, neck dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Apr 2009 (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.
Neck dissection is the main technique used by head and neck surgeons to treat known or suspected metastatic cancer to the neck. The traditional radical neck dissection was effective at treating metastatic cancer to the neck however the downside to this technique was significant morbidity. Since the early 1960's there has been several proposed techniques to treat metastatic head and neck cancer that involves preserving important anatomical structures in the neck. The disadvantage to these techniques are that they require meticulous dissection and can lead to bleeding and an increase in operative time. One particular tool that has been proposed in other surgical subspecialties, including head and neck surgery, is the harmonic scalpel. Using this tool, tissue dissection and vessel occlusion at the same time can occur with a reduced thermal damage to the surrounding tissue when compared to traditional cautery. In this study, our purpose is to determine if the harmonic scalpel will lead to a decrease in blood loss and operative time in patients undergoing a modified radical neck dissection compared to electrocautery.
Hypothesis: Use of the harmonic scalpel as a surgical adjunct will reduce operative time for neck dissection and will reduce intraoperative blood loss.
Detailed description
Patients who are referred to either the clinic of Dr. Joseph Dort or Dr. Wayne Matthews and are deemed to benefit from a modified radical neck dissection alone or as part of treatment for head and neck cancer will be given an opportunity to be a subject in this study. Once informed consent for both the surgery and the study is obtained, the lead author will be contacted and randomization will occur using a computer generated block-randomization allocation. The neck dissection will be carried out in the operating room using either electrocautery (control group) or harmonic scalpel (experimental group). The primary outcomes, blood loss (mLs) and operative time (minutes) will be assessed at the time of surgery. The blood loss in milliliters will be calculated using suction canister output, weight of sponges and irrigation used. The operative time in minutes will be calculated between the beginning of the actual neck dissection to the completion of the neck dissection defined as the removal of the surgical specimen and hemostasis of the surgical field. Intraoperative complications, namely vascular, nerve damage and lymphatic damage will be assessed at the time of surgery. Post-operative complications, both early and late will be assessed after the surgery using the Clavien post-operative complication scale. In addition, the length of time that operative drains are left in the neck will be measured with all drains being removed when their 24 hour drain output is less than 20 mls. Patients will then be followed up 2 weeks after their hospital discharge in the surgeon's clinic or the Tom Baker Cancer Centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dissection | Active comparator | Procedure: standard neck dissectionstandard neck dissection technique: scalpel and cautery. |
| Harmonic Scalpel | Experimental | Procedure: Harmonic Scalpel DissectionHarmonic scalpel used in neck dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- undergoing neck dissection (levels I-IV)
Key exclusion criteria (3 listed)
- no prior head and neck surgery
- no prior head and neck cancer
- no prior head and neck radiation
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 |
|---|---|---|
| standard neck dissectionstandard surgical technique | Procedure or surgery | Standard dissection |
| Harmonic Scalpel DissectionAlso: ethicon harmonic scalpel usedharmonic scalpel used for neck dissection after flaps are raised. | Procedure or surgery | Harmonic Scalpel |
Primary outcome
operative blood loss
Time frame: intraoperative
Operating Time
Time frame: at end of the procedure
2 secondary outcomes
wound drainage
Time frame: 48 hours
wound infection
Time frame: 48 hours, 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2010.
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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.
Joseph C Dort, BSc, MSc, MD principal investigator
University of Calgary - Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard neck dissection and Harmonic Scalpel Dissection in people with Neck Dissection, run by University of Calgary at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 14 Dec 2010. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
operative blood loss (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2010.