The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neck dissection with Harmonic scalpel
neck dissection with conventional hand-tie ligation
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and neck cancer, Neck dissection, Harmonic scalpel
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
Sites / Locations
- Yonsei University Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Harmonic scalpel
conventional hand tie ligation
Arm Description
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.
Outcomes
Primary Outcome Measures
number of harvested lymph nodes
number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection
intra-operative surgery-related complications
major vessel laceration, major nerve injury, and penetration into adjacent vital structures such as trachea or esophagus
post-operative complications
hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications
Secondary Outcome Measures
operating time
The time from the first procedure after subplatysmal flap elevation to removal of neck dissection specimen will be measured
intraoperative bleeding
Estimated blood loss from the collection bottle for the suction drain (ml) will be measured
total amount of drainage
total amount of drainage is estimated from the collection bottle of closed drain(ml)
duration of drain placement
amount of drain collected in the drain bottle is estimated daily (ml)
days of hospital stay
duration of hospital stay by days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01488682
Brief Title
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
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and neck cancer, Neck dissection, Harmonic scalpel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Harmonic scalpel
Arm Type
Experimental
Arm Description
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
Arm Title
conventional hand tie ligation
Arm Type
Active Comparator
Arm Description
electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels.
Intervention Type
Procedure
Intervention Name(s)
Neck dissection with Harmonic scalpel
Other Intervention Name(s)
Harmonic Focus® Curved Shears
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
neck dissection with conventional hand-tie ligation
Intervention Description
electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels
Primary Outcome Measure Information:
Title
number of harvested lymph nodes
Description
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
Title
intra-operative surgery-related complications
Description
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
Title
post-operative complications
Description
hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications
Time Frame
participants will be followed for 1 month after the surgery
Secondary Outcome Measure Information:
Title
operating time
Description
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
Title
intraoperative bleeding
Description
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
Title
total amount of drainage
Description
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
Title
duration of drain placement
Description
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
Title
days of hospital stay
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon Woo Koh, MD, PhD
Phone
82-10-9097-0955
Email
ywkohent@yuhs.ac
First Name & Middle Initial & Last Name or Official Title & Degree
Hyoung Shin Lee, MD
Phone
82-10-2580-6851
Email
hsleeent@yuhs.ac
Facility Information:
Facility Name
Yonsei University Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon Woo Koh, MD, PhD
Phone
82-10-9097-0955
Email
ywkohent@yuhs.ac
12. IPD Sharing Statement
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The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection
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