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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?

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02017834
Acronym
HS2
Enrollment
36
Registered
2013-12-23
Start date
2012-02-29
Completion date
2014-11-30
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cavity Squamous Cell Carcinoma, Treated With Surgery

Keywords

oral cavity squamous cell carcinoma, head and neck cancer, oral cancer

Brief 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.

Interventions

PROCEDUREsurgical resection

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

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
blood lossintraoperative

Secondary

MeasureTime frame
operating timeintraoperative

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026