LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients

Taichung Veterans General Hospital

Status and phase: Completed; Phase 4

Conditions: Head and Neck Neoplasms

Treatments: Procedure: Neck dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT02597582

TCVGH-1037004C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

41 participants in 2 patient groups

Ligusure assisted neck dissection

Active Comparator group

Description:

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.

Treatment:

Procedure: Neck dissection

Conventional neck dissection

Other group

Description:

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.

Treatment:

Procedure: Neck dissection