- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03535012
Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options
Over the past 10 years, there have been substantial improvements in breast reconstruction by plastic surgeons, and much has been achieved in aesthetic restoration after mastectomy. Advances in both microsurgery and implants have allowed for a wider variety of surgical methods, and procedural skills that minimize donor site complications have been developed.
With such satisfactory aesthetic results, interest has recently increased not only in breast reconstruction but also in sensory recovery. Due to the growing expectation of patients, sensory discomfort may decrease overall patient satisfaction with breast reconstruction despite good aesthetic results. Hence, for qualitative improvement of breast reconstruction surgery, efforts must be made to restore sensation in the reconstructed breast. There has been little research on the mechanism of sensory recovery despite its clinical importance. This study aimed to compare the degree of sensory recovery in the reconstructed breast using various reconstruction methods as well as to evaluate the status of neural regeneration with harvesting the tissues when nipple reconstruction is performed.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Seoul, Korea, Republik von, 03722
- Rekrutierung
- Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
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Kontakt:
- Dongwon Lee, MD, Ph.D
- Telefonnummer: 82-2-2228-2215
- E-Mail: XYPHOSS@yuhs.ac
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Female adults over 20 years of age
- Patients who have undergone or plan to undergo total mastectomy and immediate breast reconstruction after the diagnosis of breast cancer (including carcinoma in situ)
- written consent to study participation
Exclusion Criteria:
- presence of neuropathy that may hinder accurate assessment of sensation
- presence of dermatological condition that may hinder accurate assessment of sensation
- inability to provide written consent
- decided by the research team to be unsuitable for this study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Reconstruction using an implant
Immediate 2 stage implant based breast reconstruction after mastectomy.
All expanders are placed in the subpectoralis muscle using ADM as a sling.
After expansion of the tissue expander change to the permanent implant is performed.
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Reconstruction using abdominal tissue
immediate free DIEP flap breast reconstruction after mastectomy.
DIEP(deep inferior epigastric perforator) free flap was prepared and transferred to the breast pocket.
Microanastomosis was done under the microscopic magnification.
On sitting position, free flap was inset into breast pocket with confirming of satisfactory inflammatory fold.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Sensory recovery in the reconstructed breast according to reconstructive options
Zeitfenster: 3 months (±1 month) after immediate breast reconstruction surgery
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Subjects will be followed up with quantitative sensory testing at 3 months (±1 month) after immediate breast reconstruction surgery.
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3 months (±1 month) after immediate breast reconstruction surgery
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Sensory recovery in the reconstructed breast according to reconstructive options
Zeitfenster: 6 months (±1 month) after immediate breast reconstruction surgery
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Subjects will be followed up with quantitative sensory testing at 6 months (±1 month) after immediate breast reconstruction surgery.
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6 months (±1 month) after immediate breast reconstruction surgery
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Sensory recovery in the reconstructed breast according to reconstructive options
Zeitfenster: 12 months (±2 months) after immediate breast reconstruction surgery
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Subjects will be followed up with quantitative sensory testing at 12 months (±2 months) after immediate breast reconstruction surgery.
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12 months (±2 months) after immediate breast reconstruction surgery
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Sensory recovery in the reconstructed breast according to reconstructive options
Zeitfenster: 18 months (±2 months) after immediate breast reconstruction surgery
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Subjects will be followed up with quantitative sensory testing at 18 months (±2 months) after immediate breast reconstruction surgery.
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18 months (±2 months) after immediate breast reconstruction surgery
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 4-2015-1019
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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