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Impact of Radiotherapy on Patients Undergoing DIEP Flap Breast Reconstruction

NCT03072316 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2017-04-04

No results posted yet for this study

Summary

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

Interventions

OTHER

3D surface imaging

3D photography

OTHER

semi-structured interview

qualitative analysis using semi structured interview

OTHER

applanation tonometry

measurement of breast compressibility

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Jennifer Rusby, DM FRCS · The Royal Marsden Hospital NHS Foundation Trust

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-14
Primary Completion
2018-01-14
Completion
2018-01-14

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072316 on ClinicalTrials.gov