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

NCT04680182 | Completed

• 1 other identifier: 18-07777
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Complication

Keywords

Melanoma; Complication; Drain; Non-inferior study; Randomized study; Seroma

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of overall early complications

  To determine if the study group was non-inferior to the control group

  3-week follow up, total 3 months

Secondary Outcomes (1)

• Rate and severity of early complications

  3-week follow up, total 3 months

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Suction drain PROCEDURE

Suction drain either kept for three weeks or gradually pulled out.

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage III melanoma patients with confirmed metastases to lymph nodes in axilla or groin

You may not qualify if:

• unable to follow instructions or provide an informed written consent

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Melanoma; Seroma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in general and plastic surgery

Model Details: Non-inferiority randomised study.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: May 11, 2018
• Primary Completion: April 6, 2021
• Study Completion: September 1, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

NO (1)