Clinical trial NCT01488682: The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection
Official title: The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and neck cancer
Neck dissection
Harmonic scalpel
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of harvested lymph nodes
timeFrame: when the pathologist examine the specimen which is within 1 week after operation
measure: intra-operative surgery-related complications
timeFrame: complicated events will be monitored during the operation which takes 60 min to 160 min according to the extent of surgery
measure: post-operative complications
timeFrame: participants will be followed for 1 month after the surgery
Secondary outcomes:
measure: operating time
timeFrame: 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
measure: intraoperative bleeding
timeFrame: 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
measure: total amount of drainage
timeFrame: estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery
measure: duration of drain placement
timeFrame: estimated at 6AM daily, until the drain is removed at an average of 4 to 7 days according to the extent of surgery
measure: days of hospital stay
timeFrame: documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
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