Head and Neck CancerNCT01488682
The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection
A study testing Neck dissection with Harmonic scalpel and neck dissection with conventional hand-tie ligation in people with Head and Neck Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Neck dissection with Harmonic scalpel and neck dissection with conventional hand-tie ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Dec 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- preoperative diagnosis of head and neck squamous cell carcinoma
- surgery as initial treatment
Who cannot join
- cases in which the ND specimen could not be separated from the primary tumor
- past history of neck surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Severance Hospital
Seoul, 120-752
Yoon Woo Koh, MD, PhD, 82-10-9097-0955, ywkohent@yuhs.ac
About this study
Official title: The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study
Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Researchers investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.
- Conditions
- Head and Neck Cancer
- Being tested
- Neck dissection with Harmonic scalpel, neck dissection with conventional hand-tie ligation
- Keywords
- Head and neck cancer, Neck dissection, Harmonic scalpel
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck dissection with Harmonic scalpelProcedure or surgery
Also called Harmonic Focus® Curved Shears
The Harmonic Focus® Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH) was used for vascular control of the surgery regardless of vessel diameter, except when hand-tied or suture ligation was needed for IJV ligation or in case bleeding was not controlled with electrocoagulation
neck dissection with conventional hand-tie ligationProcedure or surgery
electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels
| Study group | Role | What they receive |
|---|---|---|
| Harmonic scalpel | Experimental | Harmonic Focus® Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH) was used for vascular control of the surgery regardless of vessel diameter, except when hand-tied or suture ligation was needed for IJV ligation or in case bleeding was not controlled with electrocoagulation Receives: Procedure: Neck dissection with Harmonic scalpel |
| conventional hand tie ligation | Active comparator | electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels. Receives: Procedure: neck dissection with conventional hand-tie ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of harvested lymph nodes
number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection
Measured: when the pathologist examine the specimen which is within 1 week after operation
intra-operative surgery-related complications
major vessel laceration, major nerve injury, and penetration into adjacent vital structures such as trachea or esophagus
Measured: complicated events will be monitored during the operation which takes 60 min to 160 min according to the extent of surgery
post-operative complications
hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications
Measured: participants will be followed for 1 month after the surgery
Secondary outcomes (5)
operating time
The time from the first procedure after subplatysmal flap elevation to removal of neck dissection specimen will be measured
Measured: when the neck dissection specimen is removed from the patient at an average time of 60 min to 160 min according to the extent of surgery
intraoperative bleeding
Estimated blood loss from the collection bottle for the suction drain (ml) will be measured
Measured: The amount will be estimated at the end of the surgery at an average time of 60 min to 160 min according to the extent of surgery
total amount of drainage
total amount of drainage is estimated from the collection bottle of closed drain(ml)
Measured: estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery
duration of drain placement
amount of drain collected in the drain bottle is estimated daily (ml)
Measured: estimated at 6AM daily, until the drain is removed at an average of 4 to 7 days according to the extent of surgery
days of hospital stay
duration of hospital stay by days
Measured: documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488682
- Sponsor's protocol ID
- 1-2011-0014
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
Publications
McCarus SD. Physiologic mechanism of the ultrasonically activated scalpel. J Am Assoc Gynecol Laparosc. 1996 Aug;3(4):601-8. doi: 10.1016/s1074-3804(05)80174-4.
PubMed 9050696Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855BuSaba NY, Schaumberg DA. Predictors of prolonged length of stay after major elective head and neck surgery. Laryngoscope. 2007 Oct;117(10):1756-63. doi: 10.1097/MLG.0b013e3180de4d85.
PubMed 17690609Patel RS, McCluskey SA, Goldstein DP, Minkovich L, Irish JC, Brown DH, Gullane PJ, Lipa JE, Gilbert RW. Clinicopathologic and therapeutic risk factors for perioperative complications and prolonged hospital stay in free flap reconstruction of the head and neck. Head Neck. 2010 Oct;32(10):1345-53. doi: 10.1002/hed.21331.
PubMed 20091687Smith TL, Smith JM. Electrosurgery in otolaryngology-head and neck surgery: principles, advances, and complications. Laryngoscope. 2001 May;111(5):769-80. doi: 10.1097/00005537-200105000-00004.
PubMed 11359154Roth JH, Urbaniak JR, Boswick JM. Comparison of suture ligation, bipolar cauterization, and hemoclip ligation in the management of small branching vessels in a rat model. J Reconstr Microsurg. 1984 Jul;1(1):7-9. doi: 10.1055/s-2007-1007047.
PubMed 6544345Ellman BR. New instrument for rapid hemostasis and division of small vessels. Am J Surg. 1982 Jun;143(6):772-3. doi: 10.1016/0002-9610(82)90058-7.
PubMed 7091517Amaral JF. Laparoscopic cholecystectomy in 200 consecutive patients using an ultrasonically activated scalpel. Surg Laparosc Endosc. 1995 Aug;5(4):255-62.
PubMed 7551275Rothenberg SS. Laparoscopic splenectomy using the harmonic scalpel. J Laparoendosc Surg. 1996 Mar;6 Suppl 1:S61-3.
PubMed 8832930Koh YW, Park JH, Lee SW, Choi EC. The harmonic scalpel technique without supplementary ligation in total thyroidectomy with central neck dissection: a prospective randomized study. Ann Surg. 2008 Jun;247(6):945-9. doi: 10.1097/SLA.0b013e31816bcd61.
PubMed 18520221Markkanen-Leppanen M, Pitkaranta A. Parotidectomy using the Harmonic scalpel. Laryngoscope. 2004 Feb;114(2):381-2. doi: 10.1097/00005537-200402000-00038. No abstract available.
PubMed 14755223Siperstein AE, Berber E, Morkoyun E. The use of the harmonic scalpel vs conventional knot tying for vessel ligation in thyroid surgery. Arch Surg. 2002 Feb;137(2):137-42. doi: 10.1001/archsurg.137.2.137.
PubMed 11822946Miccoli P, Materazzi G, Fregoli L, Panicucci E, Kunz-Martinez W, Berti P. Modified lateral neck lymphadenectomy: prospective randomized study comparing harmonic scalpel with clamp-and-tie technique. Otolaryngol Head Neck Surg. 2009 Jan;140(1):61-4. doi: 10.1016/j.otohns.2008.10.003.
PubMed 19130963Walen SG, Rudmik LR, Dixon E, Matthews TW, Nakoneshny SC, Dort JC. The utility of the harmonic scalpel in selective neck dissection: a prospective, randomized trial. Otolaryngol Head Neck Surg. 2011 Jun;144(6):894-9. doi: 10.1177/0194599811403874. Epub 2011 Mar 31.
PubMed 21493266Gall AM, Sessions DG, Ogura JH. Complications following surgery for cancer of the larynx and hypopharynx. Cancer. 1977 Feb;39(2):624-31. doi: 10.1002/1097-0142(197702)39:23.0.co;2-7.
PubMed 837342
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01488682
- Acronym / sponsor ID
- 1-2011-0014
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer, Neck dissection, Harmonic scalpel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Dec 2011 (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.
Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Researchers investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmonic scalpel | Experimental | Procedure: Neck dissection with Harmonic scalpelHarmonic Focus® Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH) was used for vascular control of the surgery regardless of vessel diameter, except when hand-tied or suture ligation was needed for IJV ligation or in case bleeding was not controlled with electrocoagulation |
| conventional hand tie ligation | Active comparator | Procedure: neck dissection with conventional hand-tie ligationelectrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- preoperative diagnosis of head and neck squamous cell carcinoma
- surgery as initial treatment
Key exclusion criteria (2 listed)
- cases in which the ND specimen could not be separated from the primary tumor
- past history of neck surgery
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 |
|---|---|---|
| Neck dissection with Harmonic scalpelAlso: Harmonic Focus® Curved ShearsThe Harmonic Focus® Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH) was used for vascular control of the surgery regardless of vessel diameter, except when hand-tied or suture ligation was needed for IJV ligation or in case bleeding was not controlled with electrocoagulation | Procedure or surgery | Harmonic scalpel |
| neck dissection with conventional hand-tie ligationelectrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels | Procedure or surgery | conventional hand tie ligation |
Primary outcome
number of harvested lymph nodes
Time frame: when the pathologist examine the specimen which is within 1 week after operation
number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection
intra-operative surgery-related complications
Time frame: complicated events will be monitored during the operation which takes 60 min to 160 min according to the extent of surgery
major vessel laceration, major nerve injury, and penetration into adjacent vital structures such as trachea or esophagus
post-operative complications
Time frame: participants will be followed for 1 month after the surgery
hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications
5 secondary outcomes
operating time
Time frame: when the neck dissection specimen is removed from the patient at an average time of 60 min to 160 min according to the extent of surgery
intraoperative bleeding
Time frame: The amount will be estimated at the end of the surgery at an average time of 60 min to 160 min according to the extent of surgery
total amount of drainage
Time frame: estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery
duration of drain placement
Time frame: estimated at 6AM daily, until the drain is removed at an average of 4 to 7 days according to the extent of surgery
days of hospital stay
Time frame: documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Background: PubMed 9050696McCarus SD. Physiologic mechanism of the ultrasonically activated scalpel. J Am Assoc Gynecol Laparosc. 1996 Aug;3(4):601-8. doi: 10.1016/s1074-3804(05)80174-4.
- Results publication: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Results publication: PubMed 17690609BuSaba NY, Schaumberg DA. Predictors of prolonged length of stay after major elective head and neck surgery. Laryngoscope. 2007 Oct;117(10):1756-63. doi: 10.1097/MLG.0b013e3180de4d85.
- Results publication: PubMed 20091687Patel RS, McCluskey SA, Goldstein DP, Minkovich L, Irish JC, Brown DH, Gullane PJ, Lipa JE, Gilbert RW. Clinicopathologic and therapeutic risk factors for perioperative complications and prolonged hospital stay in free flap reconstruction of the head and neck. Head Neck. 2010 Oct;32(10):1345-53. doi: 10.1002/hed.21331.
- Results publication: PubMed 11359154Smith TL, Smith JM. Electrosurgery in otolaryngology-head and neck surgery: principles, advances, and complications. Laryngoscope. 2001 May;111(5):769-80. doi: 10.1097/00005537-200105000-00004.
- Results publication: PubMed 6544345Roth JH, Urbaniak JR, Boswick JM. Comparison of suture ligation, bipolar cauterization, and hemoclip ligation in the management of small branching vessels in a rat model. J Reconstr Microsurg. 1984 Jul;1(1):7-9. doi: 10.1055/s-2007-1007047.
- Results publication: PubMed 7091517Ellman BR. New instrument for rapid hemostasis and division of small vessels. Am J Surg. 1982 Jun;143(6):772-3. doi: 10.1016/0002-9610(82)90058-7.
- Results publication: PubMed 7551275Amaral JF. Laparoscopic cholecystectomy in 200 consecutive patients using an ultrasonically activated scalpel. Surg Laparosc Endosc. 1995 Aug;5(4):255-62.
- Results publication: PubMed 8832930Rothenberg SS. Laparoscopic splenectomy using the harmonic scalpel. J Laparoendosc Surg. 1996 Mar;6 Suppl 1:S61-3.
- Results publication: PubMed 18520221Koh YW, Park JH, Lee SW, Choi EC. The harmonic scalpel technique without supplementary ligation in total thyroidectomy with central neck dissection: a prospective randomized study. Ann Surg. 2008 Jun;247(6):945-9. doi: 10.1097/SLA.0b013e31816bcd61.
- Results publication: PubMed 14755223Markkanen-Leppanen M, Pitkaranta A. Parotidectomy using the Harmonic scalpel. Laryngoscope. 2004 Feb;114(2):381-2. doi: 10.1097/00005537-200402000-00038. No abstract available.
- Results publication: PubMed 11822946Siperstein AE, Berber E, Morkoyun E. The use of the harmonic scalpel vs conventional knot tying for vessel ligation in thyroid surgery. Arch Surg. 2002 Feb;137(2):137-42. doi: 10.1001/archsurg.137.2.137.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck dissection with Harmonic scalpel and neck dissection with conventional hand-tie ligation in people with Head and Neck Cancer, run by Yonsei University at 1 site in South Korea.
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 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 8 Dec 2011. 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 South Korea. 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 Yoon Woo Koh, MD, PhD (82-10-9097-0955, ywkohent@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of harvested lymph nodes (time frame: when the pathologist examine the specimen which is within 1 week after operation). 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 NCT01488682, which also lists 26 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 8 Dec 2011.