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Trial record 9 of 1148 for:    Oral Cancer | ( Map: Canada )

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)

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ClinicalTrials.gov Identifier: NCT02017834
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Joseph C. Dort, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Oral Cavity Squamous Cell Carcinoma, Treated With Surgery Procedure: surgical resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Study Start Date : February 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: harmonic scalpel Procedure: surgical resection
neck dissection and tumour resection will be performed either with or without the harmonic scalpel as an adjunct.
Other Name: Harmonic Focus handpiece

Active Comparator: standard technique Procedure: surgical resection
neck dissection and tumour resection will be performed either with or without the harmonic scalpel as an adjunct.
Other Name: Harmonic Focus handpiece




Primary Outcome Measures :
  1. blood loss [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. operating time [ Time Frame: intraoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017834


Locations
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Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Joseph Dort, MD University of Calgary

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joseph C. Dort, Ohlson Professor of Head & Neck Surgery, University of Calgary
ClinicalTrials.gov Identifier: NCT02017834     History of Changes
Other Study ID Numbers: UCENT005
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2013
Keywords provided by Joseph C. Dort, University of Calgary:
oral cavity squamous cell carcinoma
head and neck cancer
oral cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell