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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neck dissection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opreation Duration | The duration from incision of cervial skin till the completion of lymph node dissection | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Postoperative Drainage Amount |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shih-An Liu, MD, PhD | Taichung Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27390305 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Conventional Neck Dissection | The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opreation Duration | The duration from incision of cervial skin till the completion of lymph node dissection | Posted | Mean | Standard Deviation | minutes | 1 day |
|
14 days after operation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shih-An Liu | Taichung Veterans General Hospital | +886-4-23592525 | 5409 | saliu@vghtc.gov.tw |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D037981 | Neck Dissection |
| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
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|
The amount of drainage from closed system drainage tube
| 2 weeks |
| Postoperative Subjective Pain Status | Visual analogue scale of subjective pain status after operation | 2 weeks |
| Postoperative Oral Analgesic Consumption | The amount of analgesic consumption via oral ingestion after operation | 2 weeks |
| Postoperative Injected Analgesic Amount | The amount of injected form analgesic used (Meperidine 50 mg/ampule) | 2 weeks |
| BG001 | Conventional Neck Dissection | The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary tumor site | Number | participants |
|
| Clinical N stage | Clinical N stage was in accordance with the guidelines of the American Joint Committee on Cancer (7th edition, 2009) Briefly, the clinical N stage was described at below. N0: No regional lymph node metastasis N1: Metastasis in a single ipsilateral lymph node, 3 cm or less in greatest dimension N2: Metastasis of regional lymph node(s), none more than 6 cm in greatest dimension Basically, a better survival is expected in N0 stage yet a worse survival is anticipated in N2 stage. | Number | participants |
|
| Levels of neck dissection | Level of cervical lymph node is based on the anatomical location Briefly, the level of cervical lymph node is described as below Level I: Submental and submandibular nodes Level II: Upper jugular nodes - Between posterior belly of digastric muscles superiorly and hyoid bone inferiorly Level III: Middle jugular nodes - between the hyoid bone and cricoid cartilage Level IV: Lower jugular nodes - between the cricoid cartilage and the clavicle Level V: Posterior cervical or spinal accessory nodes, posterior to the sternocleidomastoid muscle | Number | participants |
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| 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. | Posted | Mean | Standard Deviation | ml | 1 day |
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| Secondary | Postoperative Drainage Amount | The amount of drainage from closed system drainage tube | Posted | Mean | Standard Deviation | ml | 2 weeks |
|
|
|
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| Secondary | Postoperative Subjective Pain Status | Visual analogue scale of subjective pain status after operation | Pain visual analogue scale (VAS) (no pain: 0, intolerable pain: 10) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
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| Secondary | Postoperative Oral Analgesic Consumption | The amount of analgesic consumption via oral ingestion after operation | Posted | Mean | Standard Deviation | capsules | 2 weeks |
|
|
|
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| Secondary | Postoperative Injected Analgesic Amount | The amount of injected form analgesic used (Meperidine 50 mg/ampule) | Posted | Mean | Standard Deviation | Ampule | 2 weeks |
|
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|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Conventional Neck Dissection | The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection. | 0 | 20 | 0 | 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 12 hours after OP |
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| 1 day after OP |
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| 3 days after OP |
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| 7 days after OP |
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| 14 days after OP |
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