To study motivational and psychological aspects, aestetic outcome, and general satisfaction in two groups of women who opt for mastectomy with breast reconstruction either with autologous material using the DIEP-flap procedure or with silicon…
ID
Source
Brief title
Condition
- Other condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Health condition
gezonde vrouwen met verhoogde risico's op borstkanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- general well being
- breast cancer specific distress
- satisfaction with the aestetic outcome
Secondary outcome
none
Background summary
Facing the consequences of mastectomy, after cancer or prophylactic, women
should have access to extensive knowledge of the pros and cons of the current
methods of breast reconstruction. Several studies have been conducted on the
medical and psychological aspects of implant and autologous procedures. Since
the Diep Inferior Epigastric Perforator (DIEP) flap method is a relatively new
reconstructive method, little is known bout the psychological impact of this
procedure. This study will first identify the motivational aspects and personal
views underlying women*s* decisions regarding breast reconstruction. Second,
the study will identify and describe the psychological implications of the DIEP
flap procedure and a non-autologous method using subpectorally placed breast
implants. A comparison will be made between the outcomes of these two kinds of
post mastectomy breast reconstructions. The medical and psychological effects
of focus include: complications after reconstruction, aesthetic and general
satisfaction, psychosocial functioning and sexual functioning. Thirds, the
influence of perioperative complications on aesthetic outcome will be studied
as well in the proposed research
Study objective
To study motivational and psychological aspects, aestetic outcome, and general
satisfaction in two groups of women who opt for mastectomy with breast
reconstruction either with autologous material using the DIEP-flap procedure or
with silicon implants.
Study design
A prospective follow-up design will include women who opt for breast
reconstruction. They will be asked to participate by their consulting surgeon.
After consent they complete questionnaires before operation, and 6 and 18
months after surgery and reconstruction. At three weeks and 12 months after
surgery participants will be contacted by telephone for a short 15 minutes
interview. Subgroups of 30 participants in each group will be interviewed
before surgery. Series of photographs of the breasts will be taken before
surgery, before nipple reconstruction and after complete reconstruction.
Study burden and risks
no risk or burden
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
all patients who will undergo mastectomy (prophylactic or after cancer) at the Leiden University Medical Centre, the Erasmus University Medical Centre Rotterdam, Leyenburg Hospital The Hague and Bronovo Hospital The Hague, and who opt for breast reconstruction
Exclusion criteria
- women who had an implant reconstruction in the past and who opt for a DIEP flap reconstruction
- women who are not able to understand and speak the Dutch language sufficiently
- women who develop breast cancer during the follow up period of this study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18441.058.07 |