Phase 4
N=41
LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
Head and Neck Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02597582 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Opreation Duration — 97.1; 116.3 minutes — p=0.022
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Neck dissection (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Taichung Veterans General Hospital
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opreation Duration |
97.1; 116.3 | 0.022 sig |
| SECONDARY Intraoperative Blood Loss |
122; 144 | 0.266 |
| SECONDARY Postoperative Drainage Amount |
107; 139 | 0.060 |
| SECONDARY Postoperative Subjective Pain Status |
0.6; 0.7; 3.5; 3.4; 2.5; 2.6 | — |
| SECONDARY Postoperative Oral Analgesic Consumption |
37.2; 40.9 | 0.524 |
| SECONDARY Postoperative Injected Analgesic Amount |
8.8; 17.7 | 0.037 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02597582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.