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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The aim of this prospective randomized study was to investigate if the LigaSure vessel sealing system can reduce the operation duration and the postoperative drainage amount in patients undergoing neck dissection.

Detailed Summary:

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.


Sponsor: Taichung Veterans General Hospital

Current Primary Outcome: Opreation Duration [ Time Frame: 1 day ]

The duration from incision of cervial skin till the completion of lymph node dissection


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intraoperative Blood Loss [ Time Frame: 1 day ]
    Intraoperative blood loss was estimated by the sum of the volume in the suction bottle and the increased weight of wet gauzes containing blood after neck dissection.
  • Postoperative Drainage Amount [ Time Frame: 2 weeks ]
    The amount of drainage from closed system drainage tube
  • Postoperative Subjective Pain Status [ Time Frame: 2 weeks ]
    Visual analogue scale of subjective pain status after operation
  • Postoperative Oral Analgesic Consumption [ Time Frame: 2 weeks ]
    The amount of analgesic consumption via oral ingestion after operation
  • Postoperative Injected Analgesic Amount [ Time Frame: 2 weeks ]
    The amount of injected form analgesic used (Meperidine 50 mg/ampule)


Original Secondary Outcome:

  • Intraoperative Blood Loss [ Time Frame: 1 day ]
    Intraoperative blood loss was estimated by the sum of the volume in the suction bottle and the increased weight of wet gauzes containing blood after neck dissection.
  • Postoperative Drainage Amount [ Time Frame: 2 weeks ]
    The amount of drainage from closed system drainage tube
  • Postoperative Subjective Pain Status [ Time Frame: 2 weeks ]
    Visual analogue scale of subjective pain status after operation
  • Postoperative analgesic consumption [ Time Frame: 2 weeks ]
    The amount of analgesic consumption after operation


Information By: Taichung Veterans General Hospital

Dates:
Date Received: November 3, 2015
Date Started: January 2014
Date Completion:
Last Updated: August 24, 2016
Last Verified: August 2016