The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

Not Applicable

• Conditions: Head and Neck Cancer

• Registration Number: NCT01488682
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Status Verified: 2011-12
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Last Update Submitted: 2011-12-06
• Study First Posted: 2011-12-08
• Last Update Posted: 2011-12-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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)
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

Trial Locations

Locations (1)

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of