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LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients

Head and Neck Neoplasms Clinical Trial

Official title:
A Prospective Randomized Study of LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients

Clinical Trial Summary

There were totally 41 patients enrolled in the end of the study. The study group consisted of 20 patients while the control group had 21 patients. The operation duration was shorter (97.1 versus 116.3 minutes, P = 0.022) and the average amount of injected analgesics was lower (8.8 versus 17.7 ampules, P = 0.037) in the study group. No significant differences were noted between the two groups in demographic variables, primary tumor site, clinical N stage, levels of neck dissection, intraoperative bleeding, postoperative drainage amount/duration, and subjective postoperative pain status.

Clinical Trial Description

We compared the differences in perioperative and postoperative variables between LigaSure Small Jaw®-assisted and conventional neck dissection in head and neck cancer patients.

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02597582
Study type Interventional
Source Taichung Veterans General Hospital
Contact
Status Completed
Phase Phase 4
Start date January 2014
Completion date October 2015
View Details
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