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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04680182
Other study ID # 18-07777
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2018
Est. completion date September 1, 2022

Study information

Verified date September 2022
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date September 1, 2022
Est. primary completion date April 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate and severity of early complications Frequency of each complication and an analysis of possible risk factors. 3-week follow up, total 3 months
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