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

Phase 4

Completed

• Conditions: Head and Neck Neoplasms

• Registration Number: NCT02597582
• Lead Sponsor: Taichung Veterans General Hospital

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 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 Timeline

• Study Start: 2014-01
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Results First Submitted: 2015-11-10
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-24
• Last Update Submitted: 2016-08-24
• Results First Posted: 2016-10-18
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opreation Duration	1 day	The duration from incision of cervial skin till the completion of lymph node dissection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan