Complication, Melanoma
Conditions
Keywords
Melanoma, Complication, Drain, Non-inferior study, Randomized study, Seroma
Brief summary
This prospective randomized non-inferiority study is designed to compare the rate and severity of complications after axillary and inguinal lymph node dissection in stage III melanoma patients in a study group where the drain is left in place for three weeks and a control group consisting of patients managed according to the standard institutional protocol. Furthermore, variables associated with complications will be examined.
Detailed description
Consecutive stage III melanoma patients 18 years or older referred to our institution for axillary or inguinal lymph node dissection is eligible for inclusion of the study. A bipolar vessel sealing device (LigaSure, Covidien) will be used for dissection in all procedures. All patients will be scheduled for an outpatient visit with an experienced nurse three weeks after the surgery. Any deviation from the normal postoperative course will be recorded in the electronic patient journal. Complications are graded according to the Clavien-Dindo classification. Patients with complications or with suspected complications at the three-week follow up will be scheduled for new an outpatient visit. Patient demographics, clinicopathological characteristics of the primary melanoma, indication for the procedure, length of postoperative stay and early complications and treatment for complications will be collected for analysis
Interventions
PROCEDURESuction drain
Suction drain either kept for three weeks or gradually pulled out.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-inferiority randomised study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stage III melanoma patients with confirmed metastases to lymph nodes in axilla or groin
Exclusion criteria
* unable to follow instructions or provide an informed written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of overall early complications | 3-week follow up, total 3 months | To determine if the study group was non-inferior to the control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate and severity of early complications | 3-week follow up, total 3 months | Frequency of each complication and an analysis of possible risk factors. |
Countries
Norway
Outcome results
None listed