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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Procedure: Neck dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ligusure assisted neck dissection<br>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. | Procedure: Neck dissection<br>* 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.<br>* Other names: Ligasure vessel sealing system;|
| Other: Conventional neck dissection<br>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. | Procedure: Neck dissection<br>* 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.<br>* Other names: Ligasure vessel sealing system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opreation Duration | The duration from incision of cervial skin till the completion of lymph node dissection | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Blood Loss | 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. | 1 day | 
| Postoperative Drainage Amount | The amount of drainage from closed system drainage tube | 2 weeks | 
| Postoperative Subjective Pain Status | Visual analogue scale of subjective pain status after operation | 2 weeks | 
| Postoperative Oral Analgesic Consumption | The amount of analgesic consumption via oral ingestion after operation | 2 weeks | 
| Postoperative Injected Analgesic Amount | The amount of injected form analgesic used (Meperidine 50 mg/ampule) | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LigaSure, Neck dissection, Operative duration, Postoperative drainage, Postoperative pain