Does the Harmonic Scalpel Reduce Blood Loss and OR Time in Major Head and Neck Cancer Surgery Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma?

Oral Cavity Squamous Cell Carcinoma, Treated With Surgery Clinical Trial

— HS2  

Official title:

Does the Harmonic Scalpel Reduce Operating Time and Blood Loss in Patients Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma? A Prospective, Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017834
• Other study ID #: UCENT005
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: December 1, 2014
• Start date: February 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2013
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• oral cavity scc

• primary surgery including either uni or bilateral neck dissection (levels I-IV)

Exclusion Criteria:

• previous treatment for head and neck cancer

• unable or unwilling to give informed consent

• history of bleeding disorder

• other contraindications to surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Oral Cavity Squamous Cell Carcinoma, Treated With Surgery

Intervention

Procedure:
• surgical resection
neck dissection and tumour resection will be performed either with or without the harmonic scalpel as an adjunct.

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss		intraoperative	No
Secondary	operating time		intraoperative	No