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Sponsor study identifier
Secondary identifiers
OTHER · Research Ethics Committee for Central Region Denmark
OTHER · Data tilsynet
observational
408
1 country
1
Study Start
March 2014
Actual (reported)Primary Completion
October 2018
Actual (reported)Study Completion
October 2018
Actual (reported)Breast cancer affects a large proportion of Danish women and late morbidity following breast cancer treatment including pain, reduced motility and force of the arm and shoulder, disturbed sensitivity, and lymph edema affects many patients. The risk for such late complications have previously been carefully described by us and others in patients operated by traditional methods, but the follow-up in most of these studies have been rather short , and long time follow-up results are not available. The impact of the new oncoplastic techniques that allows more women to have breast conserving surgery is not known yet. These operations are more extensive and therefore might be accompanied by more complications. The purpose of this study is to give answer to that question.The study includes three parts. First a questionnaire to patients who have breast conserving surgery performed in one of the three breast units in Central Region Denmark. It contains questions regarding arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be filled in preoperatively and 18 months after surgery. The second part consists of an objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques. This should be performed at baseline before surgery and 18 months later. The third part is a long time follow-up of patients after breast conserving surgery without oncoplastic techniques. This group of patients is recruited from three breast units in Central Region Denmark. It contains questions regarding arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be filled in preoperatively and 18 months after surgery. The second part consists of an objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques. This should be performed at baseline before surgery and 18 months later. The third part is a long time follow-up of patients after breast conserving surgery without oncoplastic techniques. This group of patients is recruited from the cohort in a previous study with 18 months follow-up following breast conserving surgery without oncoplastic technique.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Actual (reported)June 2, 2014
Actual (reported)June 9, 2014
Actual (reported)October 2018
Actual (reported)October 2018
Actual (reported)Shoulder function
By measuring passive and active range of movement (ROM) in the shoulder, measuring strength by a dynamometer (IsoForceControl). Estimating Constant Shoulder Score.
before and 18 months after surgery
Quality of life
18 months
lymphoedema of the breast and arm
18 months
Cosmetic results
18 months
BCS without oncoplastic techniques
BCS with oncoplastic techniques.
Patients, who are undergoing breast conserving surgery (including or without oncoplastic surgical techniques) for invasive breast cancer or carcinoma in situ by one of the three breast surgical units in Central Denmark (Viborg, Randers and Aarhus). And surviving patients from the study by Husted Madsen et. al in 2003-4 ("Sentinel Node Biopsy and Breast Cancer - Aspects of introducing the method in Denmark") are invited to a new evaluation of shoulder and arm function.
Surgical department P, Aarhus University Hospital
Aarhus, 8000, Denmark
Hauerslev KR, Overgaard J, Damsgaard TE, Hvid HM, Balling E, Fischer L, Christiansen P. Oncoplastic breast surgery versus conventional breast conserving surgery - a prospective follow-up study of subjective loco-regional late morbidity. Acta Oncol. 2021 Jun;60(6):750-759. doi: 10.1080/0284186X.2021.1900907. Epub 2021 Mar 31.
Katrine R. Hauerslev, MD
University Hospital of Aarhus
408 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2014
First Posted
June 9, 2014
Study Start
March 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 2018
Actual (reported)Study Completion
October 2018
Actual (reported)Last Updated
October 29, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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