Testing whether breast tissue approximation is cosmetically better than no approximation in a breast surgical cavity.

To assess the cosmetic outcome in patients undergoing breast conservation surgery (BCS) with or without deep suture approximation of the primary surgical cavity - COSMESIS

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/06/014587

Enrollment

500

Registered

2018-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 Health Condition 2: null- Women diagnosed with breast cancer eligible for breast conservation surgery

Interventions

Intervention1: Cavity closure: Deep suture approximation of primary surgical cavity Control Intervention1: Skin closure: Primary skin closure with seroma formation

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological proven or clinically suspicious breast cancer. 2. All women with operable breast cancer planned for upfront or post NACT BCT 3. Tumours 4. Unilateral breast cancer

Exclusion criteria

Exclusion criteria: 1. Any tumor size with breast-to-tumor ratio inadequate for BCS, mandating the use of some form of oncoplasty (mobilization of adjacent breast tissue) for better cosmesis. 2. Metastatic breast cancer

Design outcomes

Primary

Measure	Time frame
To evaluate the two techniques of managing the tumour bed post Breast Conservation Surgery (BCS) and to evaluate the cosmetic outcomes related to both methods.Timepoint: Assessment of cosmesis would be done: i. Before surgery ii. 14 days after surgery iii. After completion of radiotherapy (RT) iv. 1 year post RT v. 3 years post RT	—

Secondary

Measure	Time frame
Quality of life (QOL) of patients in both the armsTimepoint: Assessment of QOL would be done: i. Before surgery ii. 14 days after surgery iii. After completion of radiotherapy (RT) iv. 1 year post RT v. 3 years post RT	—

Countries

India

Contacts

Public ContactMs Shabina Siddique

Tata Memorial Hospital

garvit22@gmail.com08879813180

Outcome results

None listed

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