Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neck dissection with Harmonic scalpel | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| post-operative complications | hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications | participants will be followed for 1 month after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| intraoperative bleeding |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoon Woo Koh, MD, PhD | Contact | 82-10-9097-0955 | ywkohent@yuhs.ac | |
| Hyoung Shin Lee, MD | Contact | 82-10-2580-6851 | hsleeent@yuhs.ac |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Recruiting | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9050696 | Background | 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. | |
| 21296855 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D037981 | Neck Dissection |
| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| neck dissection with conventional hand-tie ligation | Procedure | electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels |
|
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 |
| 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 |
| 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 |
| 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 |
| 17690609 | Result | BuSaba 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. |
| 20091687 | Result | 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 neck. Head Neck. 2010 Oct;32(10):1345-53. doi: 10.1002/hed.21331. |
| 11359154 | Result | Smith 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. |
| 6544345 | Result | 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. doi: 10.1055/s-2007-1007047. |
| 7091517 | Result | Ellman 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. |
| 7551275 | Result | Amaral JF. Laparoscopic cholecystectomy in 200 consecutive patients using an ultrasonically activated scalpel. Surg Laparosc Endosc. 1995 Aug;5(4):255-62. |
| 8832930 | Result | Rothenberg SS. Laparoscopic splenectomy using the harmonic scalpel. J Laparoendosc Surg. 1996 Mar;6 Suppl 1:S61-3. |
| 18520221 | Result | 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. |
| 14755223 | Result | Markkanen-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. |
| 11822946 | Result | 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. doi: 10.1001/archsurg.137.2.137. |
| 19130963 | Result | 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: 10.1016/j.otohns.2008.10.003. |
| 21493266 | Result | 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 2011 Mar 31. |
| 837342 | Result | Gall 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. |
| 4699538 | Result | Yarington CT Jr, Yonkers AJ, Beddoe GM. Radical neck dissection. Mortality and morbidity. Arch Otolaryngol. 1973 Apr;97(4):306-8. doi: 10.1001/archotol.1973.00780010316003. No abstract available. |
| 3141490 | Result | 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. doi: 10.1111/j.1524-4725.1988.tb03478.x. |
| 20614136 | Result | 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/s00464-010-1224-6. Epub 2010 Jul 8. |
| 12560776 | Result | Emam TA, Cuschieri A. How safe is high-power ultrasonic dissection? Ann Surg. 2003 Feb;237(2):186-91. doi: 10.1097/01.SLA.0000048454.11276.62. |
| 19005610 | Result | 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. |
| 3503020 | Result | 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. doi: 10.1016/s0950-821x(87)80004-x. |
| 15689746 | Result | 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. doi: 10.1097/01.mlg.0000154729.31281.da. |
| 15459926 | Result | 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. doi: 10.1002/hed.20095. |
| 12383306 | Result | 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. doi: 10.1046/j.1365-2273.2002.00604.x. |
| 19399751 | Result | 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. |
| 23208767 | Derived | Shin YS, Koh YW, Kim SH, Choi EC. The efficacy of the harmonic scalpel in neck dissection: a prospective randomized study. Laryngoscope. 2013 Apr;123(4):904-9. doi: 10.1002/lary.23704. Epub 2012 Dec 3. |