The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

December 6, 2011 updated by: Yonsei University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei University Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of harvested lymph nodes
Time Frame: 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
when the pathologist examine the specimen which is within 1 week after operation
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
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
Time Frame: participants will be followed for 1 month after the surgery
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
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
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
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
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
Time Frame: 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)
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
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
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
Time Frame: 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
documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2011-0014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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