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? (HS2)

University of Calgary

Status: Completed

Conditions: Oral Cavity Squamous Cell Carcinoma, Treated With Surgery

Treatments: Procedure: surgical resection

Study type: Interventional

Funder types: Other

Identifiers

NCT02017834

UCENT005

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

36 participants in 2 patient groups

harmonic scalpel

Experimental group

Treatment:

Procedure: surgical resection

standard technique

Active Comparator group

Treatment:

Procedure: surgical resection