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Patient satisfaction after mastectomy with immediate breast reconstruction.


- candidate number10545
- NTR NumberNTR3148
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2011
- Secondary IDs11-N-89/III 
- Public TitlePatient satisfaction after mastectomy with immediate breast reconstruction.
- Scientific TitlePatient satisfaction after mastectomy with immediate breast reconstruction.
- ACRONYM
- hypothesisFor patients with breast cancer who are not applicable for breast-saving treatment (because of tumor characteristics), who prefer an amputation or who undergo a prophylactic amputation an immediate breast reconstruction is a standard offer. A patient may choose, in consultation with the plastic surgeon, between an autologous reconstruction or placement of a prosthesis. In this study only the tissue expander/prosthesis will be taken into account. During this operation a tissue expander is placed after the mastectomy. After sufficient outpatient filling, the tissue expander is replaced for a definitive prosthesis. The main goal of this research is to examine whether patients are satisfied and whether the complications during or after treatment are acceptable. Whenever the satisfaction is low it is essential to examine which factors contribute or have contributed to this dissatisfaction. It is important to examine whether the dissatisfaction is due to complications or due to other patient factors.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Satisfaction, Tissue expander
- Inclusion criteriaIn this cohort study patients with unilateral breast reconstruction (by tissue expander) or bilateral breast reconstruction (by tissue expander) will be taken into account. Timing of bilateral reconstruction may be synchronous or metachronous. Our goal is to include 100 patients who received an immediate breast reconstruction in the period of January 2008 until July 2011. Patients with breast cancer who are not applicable for breast-saving treatment (because of tumor characteristics), who prefer an amputation or who undergo a prophylactic amputation will be taken into account. Patients who lost their tissue expander or prosthesis because of complications will also be taken into account.
- Exclusion criteriaPatients who received a definitive prosthesis elsewhere than the Atrium Medical Centre Parkstad will be excluded. Other criteria for exclusion include patients with other reconstructions than the tissue expander.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 14-nov-2011
- planned closingdate20-jul-2011
- Target number of participants100
- InterventionsIn this study patients who received a tissue expander in the Atrium Medical Centre Parkstad will be included. The tissue expander is placed subpectoral and filled with saline infusion. Whenever there is enough stretching of the skin a definitive prosthesis is placed. The main outcome of this study is the patient satisfaction after placement of a tissue expander and definitive prosthesis. This will be reviewed by means of a self-made questionnaire. Patients who received a tissue expander in the Atrium Medical Centre Parkstad between January 2008 and July 2011 will be included. A control group will not be included. Complications will be reviewed from the patientsí medical report.
- Primary outcomePatient satisfaction.
- Secondary outcomeComplications afterwards due to operation:
1. Infection;
2. Hematoma.
Complications due to adjuvant treatment:
1. Fibrosis;
2. Capsular contracture;
3. Poor wound healing.
- TimepointsDuring the study patients will be contacted once by means of a questionnaire. Whenever there is no response after three weeks the patient will be contacted by telephone to remind her. All questionnaires received until June/ July 2012 will be included. The study will end in July 2012.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. C. Scheeren
- CONTACT for SCIENTIFIC QUERIESDr. C. Scheeren
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad
- PublicationsN/A
- Brief summaryFor patients with breast cancer who are not applicable for breast-saving treatment (because of tumor characteristics), who prefer an amputation or who undergo a prophylactic amputation an immediate breast reconstruction is a standard offer. A patient may choose, in consultation with the plastic surgeon, between an autologous reconstruction or placement of a prosthesis. In this study only the tissue expanders will be taken into account. The tissue expander will be placed subpectoral and is, after sufficient outpatient filling, replaced for a definitive prosthesis. All patients with a tissue expander/prosthesis placed in the Atrium Medical Centre Parkstad in the period of January 2008 until July 2011 will be taken into account. The main goal of this research is to examine whether patients are satisfied and whether the complications during or after treatment are acceptable. Patientsí satisfaction will be reviewed by means of a self-made questionnaire. Complications will be reviewed from the patientsí medical report.
- Main changes (audit trail)7-Apr-2014: Trial status veranderd in: gesloten, studie afgerond. - AB
- RECORD16-nov-2011 - 7-apr-2014


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