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Assessment of side effects and quality of life in women after breast removal surgery with reconstruction

Assessment of toxicity and patient reported outcomes in women post mastectomy with reconstruction - PROPER

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/111892
Enrollment
300
Registered
2026-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Tata Memorial Centre Research Administration Council (TRAC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with a confirmed diagnosis of pre-invasive or invasive breast cancer 2. Patients planned for mastectomy with immediate reconstruction 3. Greater than 18 years 4. Implant based or autologous reconstruction

Exclusion criteria

Exclusion criteria: 1. Patient not willing to give consent 2. Unreliable for follow up 3. Patient not planned for reconstruction after mastectomy

Design outcomes

Primary

MeasureTime frame
To evaluate three-year complication rates following breast reconstruction across various combinations of reconstructive methods.Timepoint: Baseline - Pre surgery Post Surgery (2-4 weeks) Post Radiotherapy conclusion 12 months followup 24 months followup 36 months followup—

Secondary

MeasureTime frame
Difference in morbidity in irradiated vs non irradiated cohortsTimepoint: Baseline - Pre surgery Post Surgery (2-4 weeks) Post Radiotherapy conclusion 12 months followup 24 months followup 36 months followup;Difference in the PRO between implant vs autologous BRTimepoint: Baseline - Pre surgery Post Surgery (2-4 weeks) Post Radiotherapy conclusion 12 months followup 24 months followup 36 months followup;Disease related outcomes like locoregional control, disease free survival and overall survivalTimepoint: Baseline - Pre surgery Post Surgery (2-4 weeks) Post Radiotherapy conclusion 12 months followup 24 months followup 36 months followup;Validation of Breast Q reconstruction module version 2.0Timepoint: Baseline - Pre surgery Post Surgery (2-4 weeks) Post Radiotherapy conclusion 12 months followup 24 months followup 36 months followup—

Countries

India

Contacts

Public ContactDr Jyothylakshmi K H

Tata Memorial Centre

drtabs.radonc@gmail.com02224177026

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026