Trial Outcomes & Findings for LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients (NCT NCT02597582)
NCT ID: NCT02597582
Last Updated: 2016-10-18
Results Overview
The duration from incision of cervial skin till the completion of lymph node dissection
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
1 day
Results posted on
2016-10-18
Participant Flow
Participant milestones
| Measure |
Ligusure-assisted Neck Dissection
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
Baseline characteristics by cohort
| Measure |
Ligusure-assisted Neck Dissection
n=21 Participants
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.
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
n=20 Participants
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Primary tumor site
Oral cavity
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Primary tumor site
Oropharynx
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Primary tumor site
Thyroid gland
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Primary tumor site
Others
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Clinical N stage
N0
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Clinical N stage
N1
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Clinical N stage
N2
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Levels of neck dissection
Level I, II, III
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Levels of neck dissection
Level I, II, III, IV
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Levels of neck dissection
Level II, III, IV
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayThe duration from incision of cervial skin till the completion of lymph node dissection
Outcome measures
| Measure |
Ligusure-assisted Neck Dissection
n=21 Participants
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.
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
n=20 Participants
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
|
|---|---|---|
|
Opreation Duration
|
97.1 minutes
Standard Deviation 22.5
|
116.3 minutes
Standard Deviation 28.6
|
SECONDARY outcome
Timeframe: 1 dayIntraoperative 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.
Outcome measures
| Measure |
Ligusure-assisted Neck Dissection
n=21 Participants
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.
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
n=20 Participants
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
|
|---|---|---|
|
Intraoperative Blood Loss
|
122 ml
Standard Deviation 63
|
144 ml
Standard Deviation 61
|
SECONDARY outcome
Timeframe: 2 weeksThe amount of drainage from closed system drainage tube
Outcome measures
| Measure |
Ligusure-assisted Neck Dissection
n=21 Participants
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.
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
n=20 Participants
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
|
|---|---|---|
|
Postoperative Drainage Amount
|
107 ml
Standard Deviation 47
|
139 ml
Standard Deviation 58
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Pain visual analogue scale (VAS) (no pain: 0, intolerable pain: 10)
Visual analogue scale of subjective pain status after operation
Outcome measures
| Measure |
Ligusure-assisted Neck Dissection
n=21 Participants
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.
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
n=20 Participants
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
|
|---|---|---|
|
Postoperative Subjective Pain Status
Baseline
|
0.6 units on a scale
Standard Deviation 1.5
|
0.7 units on a scale
Standard Deviation 1.2
|
|
Postoperative Subjective Pain Status
6 hours after OP
|
3.5 units on a scale
Standard Deviation 2.5
|
3.4 units on a scale
Standard Deviation 2.1
|
|
Postoperative Subjective Pain Status
12 hours after OP
|
2.5 units on a scale
Standard Deviation 1.6
|
2.6 units on a scale
Standard Deviation 1.7
|
|
Postoperative Subjective Pain Status
1 day after OP
|
2.5 units on a scale
Standard Deviation 1.9
|
1.9 units on a scale
Standard Deviation 1.7
|
|
Postoperative Subjective Pain Status
3 days after OP
|
2.3 units on a scale
Standard Deviation 2.0
|
1.9 units on a scale
Standard Deviation 1.7
|
|
Postoperative Subjective Pain Status
7 days after OP
|
1.2 units on a scale
Standard Deviation 1.4
|
1.4 units on a scale
Standard Deviation 2.2
|
|
Postoperative Subjective Pain Status
14 days after OP
|
0.7 units on a scale
Standard Deviation 1.1
|
0.7 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 2 weeksThe amount of analgesic consumption via oral ingestion after operation
Outcome measures
| Measure |
Ligusure-assisted Neck Dissection
n=21 Participants
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.
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
n=20 Participants
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
|
|---|---|---|
|
Postoperative Oral Analgesic Consumption
|
37.2 capsules
Standard Deviation 15.6
|
40.9 capsules
Standard Deviation 20.7
|
SECONDARY outcome
Timeframe: 2 weeksThe amount of injected form analgesic used (Meperidine 50 mg/ampule)
Outcome measures
| Measure |
Ligusure-assisted Neck Dissection
n=21 Participants
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.
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
n=20 Participants
The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
|
|---|---|---|
|
Postoperative Injected Analgesic Amount
|
8.8 Ampule
Standard Deviation 11.3
|
17.7 Ampule
Standard Deviation 14.9
|
Adverse Events
Ligusure-assisted Neck Dissection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Neck Dissection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place