- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03541161
Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients
Early Rehabilitation After Total Mastectomy and Immediate Reconstruction With Tissue Expander Insertion in Breast Cancer Patients
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
To prevent surgical site complications, surgeons use so-called "conventional protocol", which immobilizes shoulder and upper arm motion for a month after total mastectmoy and immediate reconstruction with tissue expander insertion. To improve shoulder mobility and QOL of patients, the investigators introduced a new and early rehabilitation protocol with short-term immobilization in Jan 2017.
The investigators retrospectively reviewed total 115 breast cancer patients who underwent reconstructive surgery from May 2016 to Aug 2017. Patients who did their reconstruction before Jan 2017 followed conventional protocol and immobilized their shoulder for more than 4 weeks. Patients who did their reconstruction after Jan 2017 were educated to undergo a self-exercise program after short-term immobilization of 2 weeks. The investigators reviewed shoulder mobility, pain, QOL and complications at postoperative 1 month and 2 month in both group of patients.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Gangnam-gu
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Seoul, Gangnam-gu, Korea, Republiken av, 06351
- Samsung Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Subject has breast cancer
- Subject underwent total mastectomy and immediate reconstruction with tissue expander insertion
Exclusion Criteria:
- Patients who had pre-existing conditions before breast cancer surgery that limit shoulder movement.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Early rehabilitation group
Breast cancer patients who underwent reconstructive surgery in samsung medical center from Jan 2017 to August 2017.
Following early rehabilitation protocol, patients were educated to undergo a self-exercise program after short-term immobilization of 2 weeks.
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Conventional protocol group
Breast cancer patients who underwent reconstructive surgery in samsung medical center from May 2016 to Dec 2016.
Following conventional protocol, patients were asked to immobilize their shoulder for more than 4 weeks and then undergo self-exercise program.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The shoulder range of motion (ROM)
Tidsram: 2 month
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Shoulder ROM was measured in flexion, abduction, external rotation and internal rotation in the affected upper limb at post-operative 1 month and 2month.
Measurements were conducted by a physiatrist using a goniometer with patients in seated position.
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2 month
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Surgical site complication
Tidsram: 2 month
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A plastic surgeon reviewed the surgical site for hematoma, seroma, surgical site infection, implant rupture, extrusion of the implant, asymmetry/displacement of the implant and any other complications at post-operative 1 month and 2month.
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2 month
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Disabilities of arm, shoulder, and hand outcome measure questionnaire
Tidsram: 2 month
|
The DASH questionnaire was used to assess shoulder function at postoperative 1 month and 2 month.
Scores were transformed to a 0 to 100 scale.
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2 month
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Short-form 36 health survey
Tidsram: 2 month
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The SF36 was used to assess QOL at postoperative 1 month and 2 month.
The SF36 contains 8 sections measuring 8 domains of QOL: physical functioning (PF), role limitations because of physical health problems (RP), bodily pain (BP), general health perception (GH), vitality (VT), social functioning (SF), role limitations because of emotional problems (RE), and mental health (MH).
The 8 sections are summarized into a two-component summary: the physical component summary (PCS; PF, RP, BP, GH and VT) and mental component summary (MCS; MH, RE, SF, VT and GH).
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2 month
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Pain numeric rating scale
Tidsram: 2 month
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Self reported pain intensitiy at postoperative 1 month and 2 month.
It scored 0-10 (0 = no pain; 10= pain as bad as can be)
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2 month
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ji Hye Hwang, MD, PhD, Samsung Medical Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SMC 2018-01-008-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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