Nipple Areola Complex Conservation

NCT00641628 — Completed, Technical University of Munich
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Subcutaneous Mastectomy With Conservation of the Nipple Areola Complex: Broadening the Indications

RegistryNCT00641628
StatusCompleted
Study typeObservational
SponsorTechnical University of Munich (Other)
ConditionsBreast Cancer
Interventionsmastectomy (Procedure)
Datesstart 2003-07-01, primary completion 2006-05-01, completion 2006-05-01, first posted 2008-03-24, last updated 2008-03-24
Locations1 site in Germany

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-Summary

96 patients were offered a nipple sparing mastectomy.

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+Detailed description

96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.

+Arms and interventions

ArmTypeInterventionsDescription
1Procedure: mastectomy
  • mastectomy (Procedure), also known as breast surgery

+Outcome measures

Primary outcomes

  • tumour recurrence [07/2003 - 02/2008]
  • % of nipple areola complex conservation [07/2003 - 02/2008]

Secondary outcomes

  • cosmetics
  • patient's satisfaction

+Eligibility

Sex: Female

Inclusion Criteria:

* breast cancer

Exclusion Criteria:

* inflammatory breast cancer
* clinical skin or nipple involvement

+Locations (1)

FacilityCityCountryStatus
Klinikum rechts der IsarMunichGermany

+Publications

  • Results publication: Paepke S, Schmid R, Fleckner S, Paepke D, Niemeyer M, Schmalfeldt B, Jacobs VR, Kiechle M. Subcutaneous mastectomy with conservation of the nipple-areola skin: broadening the indications. Ann Surg. 2009 Aug;250(2):288-92. doi: 10.1097/SLA.0b013e3181b0c7d8. PMID 19638905

+Investigators