Supermicrosurgery for Breast Cancer Survivors With Lymphedema.
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|ClinicalTrials.gov Identifier: NCT03578380|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Secondary Lymphedema Breast Cancer||Procedure: Surgery Other: Compression and drainage therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.|
|Actual Study Start Date :||January 26, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2024|
Active Comparator: Compression
Conservative treatment with physiotherapy and compression
Other: Compression and drainage therapy
Treatment with compression stockings and manual drainage (massage therapy)
- Volume [ Time Frame: 12 months ]Volume of arm as described by submersion and circumference measures
- Health related quality of life ULL27 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578380
|Contact: Lars Johan Sandberg, MDfirstname.lastname@example.org|
|Skien, Telemark, Norway, NO-3710|
|Principal Investigator:||Lars Johan Sandberg, MD||Sykehuset Telemark|