The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Procedure: Neck dissection with Harmonic scalpel
* Procedure: neck dissection with conventional hand-tie ligation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Harmonic scalpel<br>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 | Procedure: Neck dissection with Harmonic scalpel<br>* 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<br>* Other names: Harmonic Focus® Curved Shears;|
| Active Comparator: conventional hand tie ligation<br>electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels. | Procedure: neck dissection with conventional hand-tie ligation<br>* electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancer, Neck dissection, Harmonic scalpel