Clinical trial · Observational
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
Comparison of Patient Reported Outcome Measures in Patients Undergoing Pre Versus Sub-pectoral Implant Based 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 PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR). This is the commonest form of breast reconstruction and current advances in surgical technology have led to increasing number of patients having implants placed above the pectoral muscle (pre-pectoral), rather than below it (sub-pectoral). This has important benefits for patients including shorter surgery time, quicker recovery, and avoidance of animation deformity (visible muscle twitching of the reconstructed breast) as the pectoral muscle is not divided to cover the implant. However, potential disadvantages include rippling effect as the implant is covered by the skin and subcutaneous tissue only, as well as potentially higher risk of capsule (scar tissue) formation. By utilising a validated questionnaire (BREAST-Q), we will assess for any difference in PROMs between the two groups of patients. The results will provide valuable information for future patients when making an informed decision about their reconstruction options. This questionnaire study will include consecutive patients undergoing mastectomy and immediate IBR for breast cancer as well as for risk reduction at Leeds Teaching Hospitals NHS Trust. The study participants will undergo either pre- or sub-pectoral IBR based on their informed discussion with the clinical team. This is a non-randomised observational study.
Conditions
Conditions (4)
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 |
| Breast Disease | — | UNRESOLVED | — |
| Patient Satisfaction | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre- or sub-pectoral implant based immediate breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing implant based immediate breast reconstruction.
- description
- Patients will undergo either pre- or sub-pectoral implant based immediate breast reconstruction.
- interventionNames
- Procedure: Pre- or sub-pectoral implant based immediate breast reconstruction
Primary outcomes (1)
- measure
- To compare any difference in patient reported outcome measures in patients undergoing pre- versus sub-pectoral implant based breast reconstruction.
- timeFrame
- Up to 12 months post-surgery
- description
- To measure the difference in BREAST-Q score in patients undergoing pre- versus sub-pectoral implant based breast reconstruction. We will compare psychosocial well-being, satisfaction with breasts, physical well-being, animation deformity, and patient experience with the clinical team.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Skin or nipple sparing mastectomy with immediate implant based reconstruction for breast cancer or for risk reduction * Unilateral or bilateral mastectomy * Implant or expander based immediate reconstruction * Able to read and understand questionnaire in English Exclusion Criteria: * Male or transgender * Mastectomy only with no reconstruction * Delayed reconstruction * Autologous reconstruction * Cognitive impairment or inability to provide informed consent
References
Publications (1)
- DERIVEDRampal R, Jones SJ, Hartup S, Robertson C, Tahir W, Jones SL, McKenzie S, Savage JA, Kim B. Three and twelve-month analysis of the PROM-Q study: comparison of patient-reported outcome measures using the BREAST-Q questionnaire in pre- vs. sub-pectoral implant-based immediate breast reconstruction. Breast Cancer Res Treat. 2024 Nov;208(2):275-282. doi: 10.1007/s10549-024-07416-5. Epub 2024 Jul 10. PMID 38985220