The objective of this study is to find answers to the question whether breast reconstruction after (preventive) mastectomy improves quality of life and which breast reconstruction technique gives the highest quality of life for these women.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
health related quality of life
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
By using quality of life questionnaires we can score the satisfaction, quality
of life and body image of patients who underwent a mastectomy with breast
reconstruction. This can be combined wit objective physical and medical
variables. Pre- and postoperative photos will be scored by a panel of experts
and a lay person.
Secondary outcome
N/A
Background summary
Between september 2006 and July 2010 the Plastic Surgery Department has
performed breast reconstructions on around 140 women with different techniques.
All techniques used are of high medical standard. Although we do have some
impressions as to what impact the women experienced concerning their quality of
life, this is not based on rigorous research. It is not clear to what extent
which technique gives the highest quality of life.
In the literature there are sufficient articles about the medical side of
breast reconstruction but a paucity of high quality research on the quality of
life outcome of breast reconstruction. This proposal concerns a retrospective
cohort study that aims at understanding the outcome, quality of life and
satisfacton of women undergoing breast reconstruction. A cohort of women who
chose not to have a breast reconstruction is used as a reference group.
Study objective
The objective of this study is to find answers to the question whether breast
reconstruction after (preventive) mastectomy improves quality of life and which
breast reconstruction technique gives the highest quality of life for these
women. Researching the outcome, psychosocial and quality of life impacts on
women who undergo breast reconstruction will enable us to further tailor the
reconstruction according tot the patients needs and to give the best possible
counselling, treatment and care.
Study design
A rretrospective cohort study has been designed whereby 3 cohorts are studied:
patients who undergo only a mastectomy, patients who have a mastectomy and an
autologous reconstruction and patients who have a mastectomy and breast
implants. These cohorts of patients have received treatment at the Division for
Surgical Oncology (Dept of Surgery) and/or the Dept of Plastic Surgery
Study burden and risks
It is unlikely that the patient will benefit personnaly from the results of the
study.
The expectation is that once the objectives of the study have been achieved,
the department can optimalize the treatment, counselling and care for future
patients.
Answering the questionnairs could be a confrontational experience. This wil be
explained in thepatient information letter and the patient will get the
opportunity to consider this aspect of the study. Ofcourse the patient can
always withdraw from the study.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
women who had a mastectomy only and women who had mastectomy plus breast reconstruction
Exclusion criteria
Patients with a poor prognosis
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 | NL33057.042.10 |