Use of the Harmonic Scalpel in Neck Dissection

NCT00875953 | Completed

• 1 other identifier: UCENT003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Neck dissection is the main technique used by head and neck surgeons to treat known or suspected metastatic cancer to the neck. The traditional radical neck dissection was effective at treating metastatic cancer to the neck however the downside to this technique was significant morbidity. Since the early 1960's there has been several proposed techniques to treat metastatic head and neck cancer that involves preserving important anatomical structures in the neck. The disadvantage to these techniques are that they require meticulous dissection and can lead to bleeding and an increase in operative time. One particular tool that has been proposed in other surgical subspecialties, including head and neck surgery, is the harmonic scalpel. Using this tool, tissue dissection and vessel occlusion at the same time can occur with a reduced thermal damage to the surrounding tissue when compared to traditional cautery. In this study, our purpose is to determine if the harmonic scalpel will lead to a decrease in blood loss and operative time in patients undergoing a modified radical neck dissection compared to electrocautery. Hypothesis: Use of the harmonic scalpel as a surgical adjunct will reduce operative time for neck dissection and will reduce intraoperative blood loss.

Conditions

Neck Dissection

Keywords

squamous cell carcinoma; head and neck cancer; neck dissection

Outcome Measures

Primary Outcomes (2)

• operative blood loss

  intraoperative

• Operating Time

  at end of the procedure

Secondary Outcomes (2)

• wound drainage

  48 hours

• wound infection

  48 hours, 1 week

Study Arms (2)

Standard dissection

ACTIVE COMPARATOR

standard neck dissection technique: scalpel and cautery.

Procedure: standard neck dissection

Harmonic Scalpel

EXPERIMENTAL

Harmonic scalpel used in neck dissection.

Procedure: Harmonic Scalpel Dissection

Interventions

standard neck dissection PROCEDURE

standard surgical technique

Standard dissection

Harmonic Scalpel Dissection PROCEDURE

harmonic scalpel used for neck dissection after flaps are raised.

Also known as: ethicon harmonic scalpel used

Harmonic Scalpel

Eligibility Criteria

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

You may qualify if:

• age \> 18 years
• undergoing neck dissection (levels I-IV)

You may not qualify if:

• no prior head and neck surgery
• no prior head and neck cancer
• no prior head and neck radiation

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Study Officials

• Joseph C Dort, BSc, MSc, MD

  University of Calgary - Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 14, 2010

Record last verified: 2009-04

Locations

CA (1)