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

NCT ID: NCT04680182

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-11

Study Completion Date

2022-09-01

Brief Summary

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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

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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

Conditions

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Melanoma Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority randomised study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Suction drain

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Suction drain

Intervention Type PROCEDURE

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

Interventions

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Suction drain

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Frich

Consultant in general and plastic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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18-07777

Identifier Type: -

Identifier Source: org_study_id

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