The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

Head and Neck Cancer Clinical Trial

Official title:

The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01488682
• Other study ID #: 1-2011-0014
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2011
• Last updated: December 6, 2011
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2011
• Source: Yonsei University
• Contact: Yoon Woo Koh, MD, PhD
• Phone: 82-10-9097-0955
• Email: ywkohent[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• preoperative diagnosis of head and neck squamous cell carcinoma

• surgery as initial treatment

Exclusion Criteria:

• cases in which the ND specimen could not be separated from the primary tumor

• past history of neck surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• Neck dissection with Harmonic scalpel
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 ligation
electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (25)

Amaral JF. Laparoscopic cholecystectomy in 200 consecutive patients using an ultrasonically activated scalpel. Surg Laparosc Endosc. 1995 Aug;5(4):255-62. — View Citation

BuSaba NY, Schaumberg DA. Predictors of prolonged length of stay after major elective head and neck surgery. Laryngoscope. 2007 Oct;117(10):1756-63. — View Citation

Cappiello J, Piazza C, Giudice M, De Maria G, Nicolai P. Shoulder disability after different selective neck dissections (levels II-IV versus levels II-V): a comparative study. Laryngoscope. 2005 Feb;115(2):259-63. — View Citation

Celik B, Coskun H, Kumas FF, Irdesel J, Zarifoglu M, Erisen L, Onart S. Accessory nerve function after level 2b-preserving selective neck dissection. Head Neck. 2009 Nov;31(11):1496-501. doi: 10.1002/hed.21112. — View Citation

El Ghani F, Van Den Brekel MW, De Goede CJ, Kuik J, Leemans CR, Smeele LE. Shoulder function and patient well-being after various types of neck dissections. Clin Otolaryngol Allied Sci. 2002 Oct;27(5):403-8. — View Citation

Ellman BR. New instrument for rapid hemostasis and division of small vessels. Am J Surg. 1982 Jun;143(6):772-3. — View Citation

Emam TA, Cuschieri A. How safe is high-power ultrasonic dissection? Ann Surg. 2003 Feb;237(2):186-91. — View Citation

Erisen L, Basel B, Irdesel J, Zarifoglu M, Coskun H, Basut O, Tezel I, Hizalan I, Onart S. Shoulder function after accessory nerve-sparing neck dissections. Head Neck. 2004 Nov;26(11):967-71. — View Citation

Fazan VP, da Silva JH, Borges CT, Ribeiro RA, Caetano AG, Filho OA. An anatomical study on the lingual-facial trunk. Surg Radiol Anat. 2009 Apr;31(4):267-70. doi: 10.1007/s00276-008-0439-x. Epub 2008 Nov 13. — View Citation

Gall AM, Sessions DG, Ogura JH. Complications following surgery for cancer of the larynx and hypopharynx. Cancer. 1977 Feb;39(2):624-31. — View Citation

Hambley R, Hebda PA, Abell E, Cohen BA, Jegasothy BV. Wound healing of skin incisions produced by ultrasonically vibrating knife, scalpel, electrosurgery, and carbon dioxide laser. J Dermatol Surg Oncol. 1988 Nov;14(11):1213-7. — View Citation

Jemal 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. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation

Koh 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. — View Citation

Mantke R, Halangk W, Habermann A, Peters B, Konrad S, Guenther M, Lippert H. Efficacy and safety of 5-mm-diameter bipolar and ultrasonic shears for cutting carotid arteries of the hybrid pig. Surg Endosc. 2011 Feb;25(2):577-85. doi: 10.1007/s00464-010-122 — View Citation

Markkanen-Leppänen M, Pitkäranta A. Parotidectomy using the Harmonic scalpel. Laryngoscope. 2004 Feb;114(2):381-2. — View Citation

McCarus SD. Physiologic mechanism of the ultrasonically activated scalpel. J Am Assoc Gynecol Laparosc. 1996 Aug;3(4):601-8. — View Citation

Miccoli 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: 1 — View Citation

Patel 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 — View Citation

Roth 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. — View Citation

Rothenberg SS. Laparoscopic splenectomy using the harmonic scalpel. J Laparoendosc Surg. 1996 Mar;6 Suppl 1:S61-3. — View Citation

Siperstein 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. — View Citation

Smith TL, Smith JM. Electrosurgery in otolaryngology-head and neck surgery: principles, advances, and complications. Laryngoscope. 2001 May;111(5):769-80. — View Citation

Walen 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 20 — View Citation

Williams MA, Nicolaides AN. Predicting the normal dimensions of the internal and external carotid arteries from the diameter of the common carotid. Eur J Vasc Surg. 1987 Apr;1(2):91-6. — View Citation

Yarington CT Jr, Yonkers AJ, Beddoe GM. Radical neck dissection. Mortality and morbidity. Arch Otolaryngol. 1973 Apr;97(4):306-8. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of harvested lymph nodes	number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection	when the pathologist examine the specimen which is within 1 week after operation	Yes
Primary	intra-operative surgery-related complications	major vessel laceration, major nerve injury, and penetration into adjacent vital structures such as trachea or esophagus	complicated events will be monitored during the operation which takes 60 min to 160 min according to the extent of surgery	Yes
Primary	post-operative complications	hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications	participants will be followed for 1 month after the surgery	Yes
Secondary	operating time	The time from the first procedure after subplatysmal flap elevation to removal of neck dissection specimen will be 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	Yes
Secondary	intraoperative bleeding	Estimated blood loss from the collection bottle for the suction drain (ml) will be 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	Yes
Secondary	total amount of drainage	total amount of drainage is estimated from the collection bottle of closed drain(ml)	estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery	Yes
Secondary	duration of drain placement	amount of drain collected in the drain bottle is estimated daily (ml)	estimated at 6AM daily, until the drain is removed at an average of 4 to 7 days according to the extent of surgery	Yes
Secondary	days of hospital stay	duration of hospital stay by days	documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery	Yes