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van CCT (UK)

van CCT (UK)

Een microchirurgische zenuwaansluiting bij eigen weefsel borstreconstructies voor verbetering van het gevoel en de kwaliteit van leven.

- candidate number29596
- NTR NumberNTR7500
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-sep-2018
- Secondary IDsNL67335.068.18 
- Public TitleEen microchirurgische zenuwaansluiting bij eigen weefsel borstreconstructies voor verbetering van het gevoel en de kwaliteit van leven.
- Scientific TitleThe Effect of Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction on the Quality of Life; A Randomized Controlled Trial
- hypothesisA microsurgical nerve coaptation in autologous breast reconstruction will improve the sensation in the reconstructed breast and therefore improve the quality of life for breast cancer patients after surgical breast cancer treatment.
- Healt Condition(s) or Problem(s) studiedBreast reconstruction, Quality of life, Recovery, Microsurgery , Sensory Recovery, Microsurgical Nerve Coaptation
- Inclusion criteria- Female sex
- 18 years or older
- Diagnosed with breast cancer or carrier of BRCA1/2 gene mutations
- Undergoing autologous breast reconstruction via DIEP flap (subcutaneous tissue from the abdomen)
- Unilateral or bilateral breast reconstruction
- Immediate or delayed breast reconstruction
- Exclusion criteria- Postoperative radiotherapy
- Known (neurological) conditions that affect the sensation such as diabetes mellitus and neruopathy (regardless of cause)
- Smoking
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2019
- planned closingdate1-jan-2023
- Target number of participants150
- InterventionsAdditional microsurgical nerve coaptation during autologous breast reconstruction with subcutaneous tissue from the abdomen (DIEP flap).
- Primary outcomeThe primary outcome of the study is the difference in BREAST-Q score between the group with and the group without sensory nerve coaptation. The domains of the BREAST-Q score range from 0 to 100 points. We consider a difference between groups of 15 points as clinically meaningful. The authors of the BREAST-Q have stated that a difference between 10-20 points can be considered as a “moderate” change in QoL6, therefore the minimal difference was set at 15 points. In our recently published pilot study, a standard deviation of approximately 25 was observed4. We need to include a total of 59 patients per group to detect a difference of 15 points with a power of 80%. We expect no more than 25% of loss to follow up. As a result, we will include a total of 75 patients per group, or 150 in total.

Baseline characteristics will be compared between groups: a DIEP flap breast reconstruction with sensory nerve coaptation (group 1) and a DIEP flap breast reconstruction without sensory nerve coaptation (group 2, which equals standard care). Continuous variables will be reported as mean with standard deviation or median with range, depending on the distribution of the variables. Categorical variables will be reported as absolute numbers and proportions. Continuous variables will be compared using the independent t test or the Mann–Whitney U test, and categorical variables were assessed using x2 test or Fisher’s exact test. In addition, linear rand generalized linear mixed-effects models will be used to compute an overall effect taking the longitudinal aspect of the measurements into account.
- Secondary outcomeSensation of the breast:
Sensation measurements of the breast(s) will be averaged in order to create one value per patient. An independent samples t test will be used to evaluate differences between both groups in mean monofilament value and mean BREAST-Q scores per domain. In addition, both simple and multiple (i.e. unadjusted and adjusted) linear regressions will be used to estimate the crude and adjusted associations between objectively measured sensation and the BREAST-Q score domains. The adjusted regression coefficient will be corrected for baseline characteristics that differed statistically significant between groups. The five additional questions will be analyzed using both simple and multiple logistic regressions and will be reported as odds ratios (OR) with a 95% confidence interval (CI). In addition, linear rand generalized linear mixed-effects models will be used to compute an overall effect taking the longitudinal aspect of the measurements into account.
A p value < 0.05 was considered to be statistically significant. All analyses will be performed using IBM SPSS.
- TimepointsQuality of life: pre-operatively, 6, 12 and 24 months post-operatively

Sensation: pre-operatively, 3, 6, 12, 18 and 24 months post-operatively
- Trial web site
- statusplanned
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Kankeronderzoekfonds Limburg, as part of Health Foundation Limburg
- Publications
- Brief summaryBreast cancer has become the most common cancer among women worldwide. Besides women receiving treatment for breast cancer, women genetically at risk because of BRCA1/2 mutations often undergo prophylactic mastectomy. Therefore, more women have to live with the consequences of (prophylactic) breast cancer treatment. In addition, the time after treatment continues to prolong since women are younger when receiving therapy. Consequently, the quality of life after (prophylactic) breast cancer treatment is becoming of fundamental importance. Restoring the body to as normal as possible, after a mastectomy has proven to increase quality of life. In terms of aesthetics, exceptional, natural looking results can already be achieved by autologous breast reconstruction. However, previous research shows that the question ‘does your reconstructed breast feel like your own?’, is one of the most important determinants in patient satisfaction. An innovative technique; sensory nerve coaptation might restore the sensation of the reconstructed breast which could significantly improve the quality of life of breast cancer patients according to the first pilot study. The aim of this study is to improve the quality of life for breast cancer patients with sensory nerve coaptation and worldwide implementation of this minimal invasive intervention.
- Main changes (audit trail)
- RECORD26-sep-2018 - 7-okt-2018

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