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?

NCT ID: NCT02017834

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Cavity Squamous Cell Carcinoma, Treated With Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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harmonic scalpel

Group Type EXPERIMENTAL

surgical resection

Intervention Type PROCEDURE

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

standard technique

Group Type ACTIVE_COMPARATOR

surgical resection

Intervention Type PROCEDURE

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

Interventions

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surgical resection

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

Intervention Type PROCEDURE

Other Intervention Names

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Harmonic Focus handpiece

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Joseph C. Dort

Ohlson Professor of Head & Neck Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Dort, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Foothills Hospital

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Fritz DK, Matthews TW, Chandarana SP, Nakoneshny SC, Dort JC. Harmonic scalpel impact on blood loss and operating time in major head and neck surgery: a randomized clinical trial. J Otolaryngol Head Neck Surg. 2016 Nov 8;45(1):58. doi: 10.1186/s40463-016-0173-z.

Reference Type DERIVED
PMID: 27821144 (View on PubMed)

Other Identifiers

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UCENT005

Identifier Type: -

Identifier Source: org_study_id