Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

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ToestandWerving

Sleutelwoorden

Abstract

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.

Omschrijving

This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).

Datums

Laatst geverifieerd:	02/29/2020
Eerste ingediend:	06/11/2017
Geschatte inschrijving ingediend:	06/23/2018
Eerst geplaatst:	07/05/2018
Laatste update ingediend:	03/16/2020
Laatste update geplaatst:	03/17/2020
Werkelijke startdatum van het onderzoek:	01/25/2016
Geschatte primaire voltooiingsdatum:	12/30/2020
Geschatte voltooiingsdatum van het onderzoek:	12/30/2024

Conditie of ziekte

Secondary Lymphedema

Breast Cancer

Interventie / behandeling

Procedure: Surgery

Other: Compression

Fase

Armgroepen

Arm	Interventie / behandeling
Experimental: Surgery Lymphovenous anastomosis	Procedure: Surgery Lymphovenous anastomosis
Active Comparator: Compression Conservative treatment with physiotherapy and compression	Other: Compression Treatment with compression stockings and manual drainage (massage therapy)

Geschiktheidscriteria

Geslachten die in aanmerking komen voor studie

All

Accepteert gezonde vrijwilligers

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Frequent or severe cellulitis. All other lymphedema.

Resultaat

Primaire uitkomstmaten

1. Volume [12 months]

Volume of arm as described by submersion and circumference measures

Secundaire uitkomstmaten

1. Health related quality of life ULL27 [12 months]

To be measured by questionnaire "Upper Limb Lymphedema score 27" (ULL27) by Professor Robert Launois at REES France. The scale measures health related quality of life in patients with upper limb lymphedema. Construction: 27 questions rated from 1 (lowest quality of life) to 5 highest quality of life. Dimensions: There are 3 dimensions assessing symptoms, self value, everyday social life. Total score 27-135 Symptom score: 18-90 Self value: 5-25 Social life: 4-20 Question 20 and 22 are part of the self value dimension and are control questions with reverse scores, i.e 1 represents highest quality of life and 5 represents lowest quality of life. The scores for question 20 and 22 are later reversed when adding the total score.

Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Sleutelwoorden

angst

borstkanker

kanker

vermoeidheid

lymfoedeem