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“A study comparing post surgery outcomes in two types of breast implants used in reconstruction after a mastectomy: one placed above the chest muscle (prepectoral) and one placed below the chest muscle (subpectoral) ?

An open-label, parallel-group randomized controlled trial comparing post-mastectomy prepectoral and subpectoral implant based breast reconstruction in breast cancer patients - nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074797
Enrollment
30
Registered
2024-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Subpectoral implant based breast reconstruction: Implant-based breast reconstruction post mastectomy in which placing the implant below the chest muscle that is below pectoralis major m

Sponsors

AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ECOG 0 and 1 Patient undergoing mastectomy for breast cancer and risk reducing surgery Presumptive adequate skin flap thickness greater than 8mm on mammogram Patient should be well oriented and coherent Both unilateral and bilateral breast surgery cases will be included

Exclusion criteria

Exclusion criteria: Patients with intraoperatively inadequate skin flaps Metastatic/Recurrent Breast cancer Pregnant or lactating women Patient refused for consent for the study.

Design outcomes

Primary

MeasureTime frame
To compare the overall postoperative outcomes of implant-based breast reconstruction between prepectoral and subpectoral surgical techniquesTimepoint: 10th day, 30th day, 60th day, and 90th day—

Secondary

MeasureTime frame
To compare between the 2 groups mentioned above: 1. Quality of life assessed by using BREAST-Q Version 2.0 2. Length of hospital stay. Timepoint: 2 years—

Countries

India

Contacts

Public ContactDR GAJENDRA PANDIT

BRAIRCH AIIMS, New Delhi

drashutoshmishra11@gmail.com9650638722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026