The aim of this study is to compare clinical outcomes and cost-effectiveness of two procedures for skin sparing mastectomy with implant reconstruction in a randomized clinical trial. The customary method for one-stage breast reconstruction with…
ID
Source
Brief title
Condition
- Other condition
- Breast therapeutic procedures
Synonym
Health condition
Borstreconstructies
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the number of reoperations as a result of
complications within the first post-operative year
Secondary outcome
Secondary outcomes are: quality of life as measured by a specific breast
related questionnaire (BREAST-Q), general quality of life measured with the
EQ-5D, complication rate, aesthetic outcome and pain. The BREAST-Q will be
administered pre-operatively and at one year after surgery, The EQ-5D is
administered every 3 months to collect cost data. Based on these data QALYs
will be calculated using the Dutch tariff.
Background summary
Skin sparing mastectomy with implant reconstruction is frequently applied in
breast cancer patients. Psychological outcome greatly improves when immediate
breast reconstruction is performed after mastectomy. However, due to inadequate
soft tissue coverage of the implant current direct implant procedures after
skin sparing mastectomy often lead to revision surgery. Recently, a novel
one-step procedure with the use of an acellular dermal matrix (ADM) has been
introduced. The method solves the problem of poor soft tissue coverage over the
implant and positive results of this procedure have been reported. Up to date
this new method has not been evaluated in a prospective randomized trial.
Study objective
The aim of this study is to compare clinical outcomes and cost-effectiveness of
two procedures for skin sparing mastectomy with implant reconstruction in a
randomized clinical trial. The customary method for one-stage breast
reconstruction with implantation of a direct implant will be compared to the
novel one-stage immediate breast reconstruction where implant is placed with an
acellular dermal matrix (ADM) inlay. We hypothesize that the addition of ADM in
immediate implant-based breast reconstruction after skin sparing mastectomy is
advantageous because it:
I. has the same or a lower re-operation rate;
II. gives a better cosmetic result;
III. is more cost-effective.
Study design
A prospective multicenter, randomized controlled clinical outcomes study.
Intervention
Eligible patients, who give informed consent, will be operated by a plastic
surgeon. Skin sparing mastectomy and implant reconstruction will be performed
in all patients. Patients will be randomized to treatment group 1 or 2 at least
three days before the mastectomy. In treatment group 1 a direct breast implant
will be placed after the mastectomy. In treatment group 2, placement of the
implant will be combined with insertion of an ADM sheet.
Study burden and risks
With regard to the intervention no extra burden will be placed on the patient.
There are no extra risks involved in either operation as both methods are
already being used by the participating surgeons. The extra burden for the
patient comprises the time for completion of questionnaires at each visit.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Females are included if they meet the following criteria:
* willing and able to participate;
* aged 18 and over;
* able to provide informed consent and
* able to complete questionnaires.
Exclusion criteria
Exclusion criteria are:
* pregnancy or planning a pregnancy during the study;
* ongoing severe psychiatric illness or mental retardation;
* evidence of alcohol and/or drug abuse;
* inability to complete the questionnaires;
* local or general infection which could jeopardize the surgical objective;
* extensive local inflammatory reactions;
* proven or suspected hypersensitivity to materials;
* immunosuppressive pathologies.
Design
Recruitment
Medical products/devices used
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 | NL48218.029.14 |