Head and Neck Cancer
Conditions
Keywords
Head and neck cancer, Neck dissection, Harmonic scalpel
Brief 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.
Interventions
PROCEDURENeck 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
PROCEDUREneck 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
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of harvested lymph nodes | 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 | 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 | participants will be followed for 1 month after the surgery | hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of drain placement | estimated at 6AM daily, until the drain is removed at an average of 4 to 7 days according to the extent of surgery | amount of drain collected in the drain bottle is estimated daily (ml) |
| operating time | 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 | The time from the first procedure after subplatysmal flap elevation to removal of neck dissection specimen will be measured |
| days of hospital stay | documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery | duration of hospital stay by days |
| intraoperative bleeding | 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 | Estimated blood loss from the collection bottle for the suction drain (ml) will be measured |
| total amount of drainage | estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery | total amount of drainage is estimated from the collection bottle of closed drain(ml) |
Countries
South Korea
Contacts
Primary ContactYoon Woo Koh, MD, PhD
Backup ContactHyoung Shin Lee, MD
Outcome results
None listed