Riskreduction of developing breast carcinoma by means of better surgical techniques (removing all normal breast tissue).
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
< 10% positive samples (glandular tissue in resectionmargin) by 60-70% of the
patients in the intervention group.
Secondary outcome
- Percentage patients with positieve sample(s).
- Location of residual breast tissue
- Risicofactors:
- Age
- Menoause
- BMI
- Weight & Volume breast
- Skinsparing mastectomy vs. simple- & radical mastetomy
- Resection surface
Background summary
After a mastectomy for breast cancer there is an realistic chance of developing
a local recurrence. It can be either a metastasis of the primary tumor or a
second primary tumor which has developed in the remaining breast tissue. The
finding of normal breast tissue around the recurrence and the development of
breast cancer after a prophylactic mastectomy support this view. So far little
is known about residual breast tissue after a mastectomy.
Study objective
Riskreduction of developing breast carcinoma by means of better surgical
techniques (removing all normal breast tissue).
Study design
Multiple sections will be taken from the periphery (breast preparation) to
detect areas where glandular tissues might extend to the resection margins.
Informing the surgeons about the regions of predilection for leaving breast
tissue behind and analysing the percentages of glandular tissue in the
periphery in the control groups vs the intervention group (Kruskal-Wallis test
& Chi2 test).
Intervention
The intervention consists of informing the surgeons about the regions of
predilection for leaving breast tissue behind.
Study burden and risks
No risico's.
Postbus 888
8901 BR Leeuwarden
Nederland
Postbus 888
8901 BR Leeuwarden
Nederland
Listed location countries
Age
Inclusion criteria
Simple or radical mastectomy for malignancy, benign disorders or prophylactic.
Exclusion criteria
Male
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 | NL21801.099.08 |