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

Not Applicable

Completed

• Conditions: Melanoma; Complication
• Interventions: Procedure: Suction drain

• Registration Number: NCT04680182
• Lead Sponsor: Oslo University Hospital

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

Study Timeline

• Study Start: 2018-05-11
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Primary Completion: 2021-04-06
• Status Verified: 2022-09
• Study Completion: 2022-09-01
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Suction drain	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.
Study group	Suction drain	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate and severity of early complications	3-week follow up, total 3 months	Frequency of each complication and an analysis of possible risk factors.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway