Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients

September 1, 2022 updated by: Lars Frich, Oslo University Hospital

Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients: A Prospective Randomized Trial of Two Approaches to Wound Drainage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
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.
Procedure: Suction drain
Suction drain either kept for three weeks or gradually pulled out.
Active Comparator: Control group
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.
Procedure: Suction drain
Suction drain either kept for three weeks or gradually pulled out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority of overall early complications
Time Frame: 3-week follow up, total 3 months
To determine if the study group was non-inferior to the control group
3-week follow up, total 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate and severity of early complications
Time Frame: 3-week follow up, total 3 months
Frequency of each complication and an analysis of possible risk factors.
3-week follow up, total 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2018

Primary Completion (Actual)

April 6, 2021

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-07777

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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