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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)

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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