Head and Neck Neoplasms
Conditions
Keywords
LigaSure, Neck dissection, Operative duration, Postoperative drainage, Postoperative pain
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.
Interventions
PROCEDURENeck dissection
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.
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opreation Duration | 1 day | The duration from incision of cervial skin till the completion of lymph node dissection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Subjective Pain Status | 2 weeks | Visual analogue scale of subjective pain status after operation |
| 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 Drainage Amount | 2 weeks | The amount of drainage from closed system drainage tube |
| Postoperative Injected Analgesic Amount | 2 weeks | The amount of injected form analgesic used (Meperidine 50 mg/ampule) |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Conventional Neck Dissection The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection. | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Ligusure-assisted Neck Dissection | Conventional Neck Dissection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 37 Participants |
| Age, Continuous | 53.6 years STANDARD_DEVIATION 9.3 | 51.1 years STANDARD_DEVIATION 8.1 | 52.4 years STANDARD_DEVIATION 8.7 |
| Clinical N stage N0 | 8 participants | 11 participants | 19 participants |
| Clinical N stage N1 | 6 participants | 2 participants | 8 participants |
| Clinical N stage N2 | 7 participants | 7 participants | 14 participants |
| Levels of neck dissection Level I, II, III | 12 participants | 14 participants | 26 participants |
| Levels of neck dissection Level I, II, III, IV | 3 participants | 3 participants | 6 participants |
| Levels of neck dissection Level II, III, IV | 6 participants | 3 participants | 9 participants |
| Primary tumor site Oral cavity | 12 participants | 12 participants | 24 participants |
| Primary tumor site Oropharynx | 3 participants | 3 participants | 6 participants |
| Primary tumor site Others | 3 participants | 3 participants | 6 participants |
| Primary tumor site Thyroid gland | 3 participants | 2 participants | 5 participants |
| Region of Enrollment Taiwan | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 16 Participants | 18 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Opreation Duration
The duration from incision of cervial skin till the completion of lymph node dissection
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ligusure-assisted Neck Dissection | Opreation Duration | 97.1 minutes | Standard Deviation 22.5 |
| Conventional Neck Dissection | Opreation Duration | 116.3 minutes | Standard Deviation 28.6 |
p-value: 0.022t-test, 2 sided
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ligusure-assisted Neck Dissection | Intraoperative Blood Loss | 122 ml | Standard Deviation 63 |
| Conventional Neck Dissection | Intraoperative Blood Loss | 144 ml | Standard Deviation 61 |
p-value: 0.266t-test, 2 sided
Secondary
Postoperative Drainage Amount
The amount of drainage from closed system drainage tube
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ligusure-assisted Neck Dissection | Postoperative Drainage Amount | 107 ml | Standard Deviation 47 |
| Conventional Neck Dissection | Postoperative Drainage Amount | 139 ml | Standard Deviation 58 |
p-value: 0.06t-test, 2 sided
Secondary
Postoperative Injected Analgesic Amount
The amount of injected form analgesic used (Meperidine 50 mg/ampule)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ligusure-assisted Neck Dissection | Postoperative Injected Analgesic Amount | 8.8 Ampule | Standard Deviation 11.3 |
| Conventional Neck Dissection | Postoperative Injected Analgesic Amount | 17.7 Ampule | Standard Deviation 14.9 |
p-value: 0.037Wilcoxon (Mann-Whitney)
Secondary
Postoperative Oral Analgesic Consumption
The amount of analgesic consumption via oral ingestion after operation
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ligusure-assisted Neck Dissection | Postoperative Oral Analgesic Consumption | 37.2 capsules | Standard Deviation 15.6 |
| Conventional Neck Dissection | Postoperative Oral Analgesic Consumption | 40.9 capsules | Standard Deviation 20.7 |
p-value: 0.524t-test, 2 sided
Secondary
Postoperative Subjective Pain Status
Visual analogue scale of subjective pain status after operation
Time frame: 2 weeks
Population: Pain visual analogue scale (VAS) (no pain: 0, intolerable pain: 10)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ligusure-assisted Neck Dissection | Postoperative Subjective Pain Status | 12 hours after OP | 2.5 units on a scale | Standard Deviation 1.6 |
| Ligusure-assisted Neck Dissection | Postoperative Subjective Pain Status | 3 days after OP | 2.3 units on a scale | Standard Deviation 2 |
| Ligusure-assisted Neck Dissection | Postoperative Subjective Pain Status | 6 hours after OP | 3.5 units on a scale | Standard Deviation 2.5 |
| Ligusure-assisted Neck Dissection | Postoperative Subjective Pain Status | 7 days after OP | 1.2 units on a scale | Standard Deviation 1.4 |
| Ligusure-assisted Neck Dissection | Postoperative Subjective Pain Status | 1 day after OP | 2.5 units on a scale | Standard Deviation 1.9 |
| Ligusure-assisted Neck Dissection | Postoperative Subjective Pain Status | 14 days after OP | 0.7 units on a scale | Standard Deviation 1.1 |
| Ligusure-assisted Neck Dissection | Postoperative Subjective Pain Status | Baseline | 0.6 units on a scale | Standard Deviation 1.5 |
| Conventional Neck Dissection | Postoperative Subjective Pain Status | 14 days after OP | 0.7 units on a scale | Standard Deviation 1.3 |
| Conventional Neck Dissection | Postoperative Subjective Pain Status | Baseline | 0.7 units on a scale | Standard Deviation 1.2 |
| Conventional Neck Dissection | Postoperative Subjective Pain Status | 6 hours after OP | 3.4 units on a scale | Standard Deviation 2.1 |
| Conventional Neck Dissection | Postoperative Subjective Pain Status | 12 hours after OP | 2.6 units on a scale | Standard Deviation 1.7 |
| Conventional Neck Dissection | Postoperative Subjective Pain Status | 1 day after OP | 1.9 units on a scale | Standard Deviation 1.7 |
| Conventional Neck Dissection | Postoperative Subjective Pain Status | 3 days after OP | 1.9 units on a scale | Standard Deviation 1.7 |
| Conventional Neck Dissection | Postoperative Subjective Pain Status | 7 days after OP | 1.4 units on a scale | Standard Deviation 2.2 |