Head and Neck NeoplasmsPhase 4NCT02597582
LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
A Phase 4 study testing Neck dissection in people with Head and Neck Neoplasms, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Neck dissection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck cancer
Who cannot join
- history of coagulation disorders
- prior radiation to the neck
- prior neck dissection
- declined to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study of 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.
Read the 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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Neck dissection
- Keywords
- LigaSure, Neck dissection, Operative duration, Postoperative drainage, Postoperative pain
- Medical subject headings
- Head and Neck Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck dissectionProcedure or surgery
Also called Ligasure vessel sealing system
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opreation Duration
The duration from incision of cervial skin till the completion of lymph node dissection
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 1 day
Postoperative Drainage Amount
The amount of drainage from closed system drainage tube
Measured: 2 weeks
Postoperative Subjective Pain Status
Visual analogue scale of subjective pain status after operation
Measured: 2 weeks
Postoperative Oral Analgesic Consumption
The amount of analgesic consumption via oral ingestion after operation
Measured: 2 weeks
Postoperative Injected Analgesic Amount
The amount of injected form analgesic used (Meperidine 50 mg/ampule)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-An Liu, Taichung Veterans General Hospital
- Investigators
- Shih-An Liu, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597582
- Sponsor's protocol ID
- TCVGH-1037004C
- Status last verified
- Aug 2016
- First submitted
- 3 Nov 2015
- Last updated
- 18 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27390305
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT02597582
- Acronym / sponsor ID
- TCVGH-1037004C
- Conditions
- Head and Neck Neoplasms
- Keywords
- LigaSure, Neck dissection, Operative duration, Postoperative drainage, Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Posted 18 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligusure assisted neck dissection | Active comparator | Procedure: Neck dissectionThe 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. |
| Conventional neck dissection | Other | Procedure: Neck dissectionThe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck cancer
Key exclusion criteria (4 listed)
- history of coagulation disorders
- prior radiation to the neck
- prior neck dissection
- declined to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck dissectionAlso: Ligasure vessel sealing systemThe 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. | Procedure or surgery | Conventional neck dissection, Ligusure assisted neck dissection |
Primary outcome
Opreation Duration
Time frame: 1 day
The duration from incision of cervial skin till the completion of lymph node dissection
5 secondary outcomes
Intraoperative Blood Loss
Time frame: 1 day
Postoperative Drainage Amount
Time frame: 2 weeks
Postoperative Subjective Pain Status
Time frame: 2 weeks
Postoperative Oral Analgesic Consumption
Time frame: 2 weeks
Postoperative Injected Analgesic Amount
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27390305Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-An Liu, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neck dissection in people with Head and Neck Neoplasms, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opreation Duration (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.