The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01488682
First received: December 5, 2011
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Procedure: Neck dissection with Harmonic scalpel
Procedure: neck dissection with conventional hand-tie ligation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • number of harvested lymph nodes [ Time Frame: when the pathologist examine the specimen which is within 1 week after operation ] [ Designated as safety issue: Yes ]
    number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection

  • intra-operative surgery-related complications [ Time Frame: complicated events will be monitored during the operation which takes 60 min to 160 min according to the extent of surgery ] [ Designated as safety issue: Yes ]
    major vessel laceration, major nerve injury, and penetration into adjacent vital structures such as trachea or esophagus

  • post-operative complications [ Time Frame: participants will be followed for 1 month after the surgery ] [ Designated as safety issue: Yes ]
    hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications


Secondary Outcome Measures:
  • operating time [ 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 ] [ Designated as safety issue: Yes ]
    The time from the first procedure after subplatysmal flap elevation to removal of neck dissection specimen will be measured

  • intraoperative bleeding [ 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 ] [ Designated as safety issue: Yes ]
    Estimated blood loss from the collection bottle for the suction drain (ml) will be measured

  • total amount of drainage [ Time Frame: estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery ] [ Designated as safety issue: Yes ]
    total amount of drainage is estimated from the collection bottle of closed drain(ml)

  • duration of drain placement [ 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 ] [ Designated as safety issue: Yes ]
    amount of drain collected in the drain bottle is estimated daily (ml)

  • days of hospital stay [ Time Frame: documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery ] [ Designated as safety issue: Yes ]
    duration of hospital stay by days


Estimated Enrollment: 59
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Harmonic scalpel
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
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
Other Name: Harmonic Focus® Curved Shears
Active Comparator: 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.
Procedure: neck 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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488682

Contacts
Contact: Yoon Woo Koh, MD, PhD 82-10-9097-0955 ywkohent@yuhs.ac
Contact: Hyoung Shin Lee, MD 82-10-2580-6851 hsleeent@yuhs.ac

Locations
Korea, Republic of
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yoon Woo Koh, MD, PhD    82-10-9097-0955    ywkohent@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01488682     History of Changes
Other Study ID Numbers: 1-2011-0014
Study First Received: December 5, 2011
Last Updated: December 6, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Head and neck cancer
Neck dissection
Harmonic scalpel

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014