Clinical trial · Observational
Impact of Radiotherapy on Patients Undergoing DIEP Flap Breast Reconstruction
Case Control Study to Evaluate the Impact of Radiotherapy on Patients Undergoing DIEP Flap Breast Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators intend to undertake a study to investigate the effect of radiotherapy on deep inferior epigastric perforator flap reconstructions (DIEP). Adjuvant post-mastectomy radiotherapy (PMRT) is offered to women at high risk of chest wall recurrence. The perceived detrimental effect of radiotherapy on an immediate breast reconstruction and the "one-off" nature of autologous reconstruction leads some surgeons to recommend delayed reconstruction after mastectomy or to use a temporising implant with a view to planned exchange to autologous reconstruction after radiotherapy. However, there remains significant uncertainty in the literature about the impact of radiotherapy on autologous reconstructions. This study is a mixed methology study using patient reported outcome measures (PROMS), applanation tonometry (measure of breast compressibility), semi-structured interviews and 3 dimensional photography analysis to compare the aesthetic and impact on quality of life on the following groups of patients: Patient groups: 1. Unilateral skin sparing mastectomy (SSM) with immediate DIEP flap reconstruction and PMRT (cases) 2. Unilateral SSM with immediate DIEP flap reconstruction and no PMRT (controls) 3. Unilateral simple mastectomy, PMRT, and subsequent delayed DIEP flap reconstruction (controls) 4. Unilateral SSM with temporizing implant, PMRT and subsequent conversion to DIEP (controls)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D surface imaging | Other | — | UNRESOLVED |
| applanation tonometry | Other | — | UNRESOLVED |
| semi-structured interview | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- SSM immediate DIEP
- description
- Unilateral skin sparing mastectomy with immediate DIEP
- interventionNames
- Other: 3D surface imaging
- Other: semi-structured interview
- Other: applanation tonometry
- label
- SSM immediate DIEP and PMRT
- description
- Unilateral skin sparing mastectomy with immediate DIEP flap reconstruction and post mastectomy radiotherapy
- interventionNames
- Other: 3D surface imaging
- Other: semi-structured interview
- Other: applanation tonometry
- label
- mastectomy, PMRT, delayed DIEP
- description
- simple mastectomy, post mastectomy radiotherapy adn then delayed DIEP reconstruction
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Women who have undergone one of the treatment sequences above (a) - (d) Patient groups: 1. Unilateral skin sparing mastectomy (SSM) with immediate DIEP flap reconstruction and PMRT (cases) 2. Unilateral SSM with immediate DIEP flap reconstruction and no PMRT (controls) 3. Unilateral simple mastectomy, PMRT, and subsequent delayed DIEP flap reconstruction (controls) 4. Unilateral SSM with temporizing implant, PMRT and subsequent conversion to DIEP (controls) 2. Patients of any age will be included 3. Patients who are between one and five years post initial breast reconstruction surgery or radiotherapy (which ever is most recent) Exclusion Criteria: 1. Women who have undergone bilateral mastectomy, even if the contralateral mastectomy was asynchronous. 2. Women who are less than one year from their last radiotherapy treatment or from their DIEP flap reconstruction. 3. Patients who have had more than one implant based operation before DIEP flap (revision surgery to the implant implies that an implant based reconstruction was the primary intent and therefore the DIEP flap is a 'salvage' procedure) or if it is documented to be a salvage reconstruction. 4. Women who have developed recurrent / distant disease. 5. Women who are unable to stand for the 3D imaging (approximately 10 minutes) 6. Women who are unable to complete the English language questionnaire or interview (i.e. learning difficulties or patients who do not have adequate English language skills). \-
References
Publications (1)
- DERIVEDO'Connell RL, Di Micco R, Khabra K, Kirby AM, Harris PA, James SE, Power K, Ramsey KWD, Rusby JE. Comparison of Immediate versus Delayed DIEP Flap Reconstruction in Women Who Require Postmastectomy Radiotherapy. Plast Reconstr Surg. 2018 Sep;142(3):594-605. doi: 10.1097/PRS.0000000000004676. PMID 29927832