NCT02597582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 18, 2016

Completed
Last Updated

October 18, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

November 3, 2015

Results QC Date

November 10, 2015

Last Update Submit

August 24, 2016

Conditions

Head and Neck Neoplasms

Keywords

LigaSureNeck dissectionOperative durationPostoperative drainagePostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Opreation Duration

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

    1 day

Secondary Outcomes (5)

  • Intraoperative Blood Loss

    1 day

  • Postoperative Drainage Amount

    2 weeks

  • Postoperative Subjective Pain Status

    2 weeks

  • Postoperative Oral Analgesic Consumption

    2 weeks

  • Postoperative Injected Analgesic Amount

    2 weeks

Study Arms (2)

Ligusure assisted neck dissection

ACTIVE COMPARATOR

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

Conventional neck dissection

OTHER

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

Interventions

Neck dissectionPROCEDURE

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.

Also known as: Ligasure vessel sealing system
Conventional neck dissectionLigusure assisted neck dissection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

Location

Related Publications (1)

  • Lin WJ, Wang CC, Jiang RS, Huang YC, Ho HC, Liu SA. A prospective randomised trial of LigaSure Small Jaw(R) versus conventional neck dissection in head and neck cancer patients. Clin Otolaryngol. 2017 Apr;42(2):245-251. doi: 10.1111/coa.12702. Epub 2016 Jul 26.

    PMID: 27390305DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsPain, Postoperative

Interventions

Neck Dissection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Lymph Node ExcisionSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Results Point of Contact

Title
Shih-An Liu
Organization
Taichung Veterans General Hospital
saliu@vghtc.gov.tw
+886-4-23592525

Study Officials

  • Shih-An Liu, MD, PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 5, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 18, 2016

Results First Posted

October 18, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)