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NCT Number: NCT02597582

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

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck cancer

Exclusion criteria

  • history of coagulation disorders
  • prior radiation to the neck
  • prior neck dissection
  • declined to participate

Treatment and study plan

Neck dissection

Procedure

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 names: Ligasure vessel sealing system

Primary outcomes

  1. Opreation Duration

    Time frame: 1 day

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

Secondary outcomes

  1. 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.

  2. Postoperative Drainage Amount

    Time frame: 2 weeks

    The amount of drainage from closed system drainage tube

  3. Postoperative Subjective Pain Status

    Time frame: 2 weeks

    Visual analogue scale of subjective pain status after operation

  4. Postoperative Oral Analgesic Consumption

    Time frame: 2 weeks

    The amount of analgesic consumption via oral ingestion after operation

  5. Postoperative Injected Analgesic Amount

    Time frame: 2 weeks

    The amount of injected form analgesic used (Meperidine 50 mg/ampule)

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2015
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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