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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
59
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
electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels
Yonsei University Severance Hospital
Seoul, South Korea
RECRUITINGnumber of harvested lymph nodes
number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection
Time frame: 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
Time frame: 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
Time frame: participants will be followed for 1 month after the surgery
operating time
The time from the first procedure after subplatysmal flap elevation to removal of neck dissection specimen will be measured
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
Estimated blood loss from the collection bottle for the suction drain (ml) will be measured
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
total amount of drainage is estimated from the collection bottle of closed drain(ml)
Time frame: estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
duration of drain placement
amount of drain collected in the drain bottle is estimated daily (ml)
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
duration of hospital stay by days
Time frame: documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery