NCT03578380

Brief Summary

A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 18, 2023

Status Verified

December 1, 2022

Enrollment Period

8.9 years

First QC Date

June 12, 2017

Last Update Submit

April 15, 2023

Conditions

Secondary LymphedemaBreast Cancer

Keywords

Lymphovenous bypassLymphovenous anastomosisSupermicrosurgeryLymphangiographyMD Anderson Lymphedema Stage

Outcome Measures

Primary Outcomes (1)

  • Volume

    Volume of arm as described by submersion and circumference measures

    12 months

Secondary Outcomes (1)

  • Health related quality of life ULL27

    12 months

Study Arms (2)

Surgery

EXPERIMENTAL

Lymphovenous anastomosis

Procedure: Surgery

Compression

ACTIVE COMPARATOR

Conservative treatment with physiotherapy and compression

Other: Compression and drainage therapy

Interventions

SurgeryPROCEDURE

Lymphovenous anastomosis

Surgery
Compression and drainage therapyOTHER

Treatment with compression stockings and manual drainage (massage therapy)

Compression

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema.

You may not qualify if:

  • Frequent or severe cellulitis. All other lymphedema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset Telemark

Skien, Telemark, NO-3710, Norway

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lars Johan Sandberg, MD

    Sykehuset Telemark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Johan Sandberg, MD

CONTACT

+4735003456johansandberg@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

July 6, 2018

Study Start

January 26, 2016

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 18, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD with other researchers

Locations

NO(1)