Back to resultsEarly Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients
Primary Purpose
Melanoma, Complication
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Suction drain
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Complication, Drain, Non-inferior study, Randomized study, Seroma
Eligibility Criteria
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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
Wound drain is kept until until a scheduled visit three weeks after the surgery unless the drain produced less than 30 ml/day for two consecutive days, in which case it could be removed earlier.
When the drain produces less than 100 mL over 24 hours, the self-suction bulb is removed and the drain is shortened and drained into a colostomy bag placed around the site of drain insertion. A request is filed with the community nursing system to have a visiting nurse to pull out the drain 1-2 cm per day.
Outcomes
Primary Outcome Measures
Non-inferiority of overall early complications
To determine if the study group was non-inferior to the control group
Secondary Outcome Measures
Rate and severity of early complications
Frequency of each complication and an analysis of possible risk factors.
Full Information
NCT ID
NCT04680182
First Posted
December 17, 2020
Last Updated
September 1, 2022
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04680182
Brief Title
Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients
Official Title
Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients: A Prospective Randomized Trial of Two Approaches to Wound Drainage
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
April 6, 2021 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Complication
Keywords
Melanoma, Complication, Drain, Non-inferior study, Randomized study, Seroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-inferiority randomised study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Wound drain is kept until until a scheduled visit three weeks after the surgery unless the drain produced less than 30 ml/day for two consecutive days, in which case it could be removed earlier.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
When the drain produces less than 100 mL over 24 hours, the self-suction bulb is removed and the drain is shortened and drained into a colostomy bag placed around the site of drain insertion. A request is filed with the community nursing system to have a visiting nurse to pull out the drain 1-2 cm per day.
Intervention Type
Procedure
Intervention Name(s)
Suction drain
Intervention Description
Suction drain either kept for three weeks or gradually pulled out.
Primary Outcome Measure Information:
Title
Non-inferiority of overall early complications
Description
To determine if the study group was non-inferior to the control group
Time Frame
3-week follow up, total 3 months
Secondary Outcome Measure Information:
Title
Rate and severity of early complications
Description
Frequency of each complication and an analysis of possible risk factors.
Time Frame
3-week follow up, total 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients
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