The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

NCT01488682 | Unknown

• 1 other identifier: 1-2011-0014
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer; Neck dissection; Harmonic scalpel

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Harmonic scalpel

EXPERIMENTAL

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

conventional hand tie ligation

ACTIVE COMPARATOR

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

Interventions

Neck dissection with Harmonic scalpel PROCEDURE

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

Also known as: Harmonic Focus® Curved Shears

Harmonic scalpel

neck dissection with conventional hand-tie ligation PROCEDURE

electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels

conventional hand tie ligation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• preoperative diagnosis of head and neck squamous cell carcinoma
• surgery as initial treatment

You may not qualify if:

• cases in which the ND specimen could not be separated from the primary tumor
• past history of neck surgery

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Related Publications (26)

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  PMID: 23208767 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Neck Dissection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Lymph Node Excision; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Central Study Contacts

Yoon Woo Koh, MD, PhD

CONTACT

82-10-9097-0955; ywkohent@yuhs.ac

Hyoung Shin Lee, MD

CONTACT

82-10-2580-6851; hsleeent@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 8, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

KR (1)