LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
NCT ID: NCT02597582
Last Updated: 2016-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2014-01-31
2015-10-31
Brief Summary
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Detailed Description
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Patients who were scheduled to undergo neck dissection due to head and neck cancer were eligible for this study. After receiving a detailed explanation, all patients signed an informed consent form before randomization. The study group were treated using the LigaSure vessel sealing system (Small Jaw®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection. Relevant data included tumor-related variables, perioperative parameters, postoperative drainage status, postoperative subjective pain, and analgesic consumption amount were recorded and analyzed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Ligusure assisted neck dissection
The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.
Neck dissection
The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device.
Conventional neck dissection
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.
Neck dissection
The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device.
Interventions
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Neck dissection
The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* prior radiation to the neck
* prior neck dissection
* declined to participate
20 Years
80 Years
ALL
No
Sponsors
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Taichung Veterans General Hospital
OTHER
Responsible Party
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Shih-An Liu
Attending physician
Principal Investigators
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Shih-An Liu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Taichung Veterans General Hospital
Locations
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Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan
Countries
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References
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Lin WJ, Wang CC, Jiang RS, Huang YC, Ho HC, Liu SA. A prospective randomised trial of LigaSure Small Jaw(R) versus conventional neck dissection in head and neck cancer patients. Clin Otolaryngol. 2017 Apr;42(2):245-251. doi: 10.1111/coa.12702. Epub 2016 Jul 26.
Other Identifiers
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TCVGH-1037004C
Identifier Type: -
Identifier Source: org_study_id
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