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 Details — Status: Completed

Administrative data

• NCT number: NCT02597582
• Other study ID #: TCVGH-1037004C
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2015
• Last updated: November 3, 2015
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Device:
• Ligasure small jaw (Covidien, Colorado, USA)
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.
• Conventional neck dissection
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opreation duration	The duration from incision of cervial skin till the completion of lymph node dissection	1 day	No
Secondary	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	No
Secondary	Postoperative drainage amount	The amount of drainage from closed system drainage tube	2 weeks	No
Secondary	Postoperative subjective pain status	Visual analogue scale of subjective pain status after operation	2 weeks	No
Secondary	Postoperative analgesic consumption	The amount of analgesic consumption after operation	2 weeks	No