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

Sponsor

Oslo University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04680182

Collaborator

(none)

100

Enrollment

Location

Arms

35.7

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Complication	Procedure: Suction drain	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Non-inferiority randomised study.Non-inferiority randomised study.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 11, 2018

Actual Primary Completion Date :

Apr 6, 2021

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway

Sponsors and Collaborators

Oslo University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lars Frich, Consultant in general and plastic surgery, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT04680182

Other Study ID Numbers:

18-07777

First Posted:

Dec 22, 2020

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lars Frich, Consultant in general and plastic surgery, Oslo University Hospital

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Apr 8, 2021