To study the benefit of addition of drainage of lymph fluid from arm to vein in prevention of swelling of arm (lymphedema) in patients undergoing removal of nodes from armpit in Breast Carcinoma.

A Randomised trial to study the outcome of addition of Lymphatico-venous Anastomosis to standard of care for prevention of upper extremity Lymphedema in patients undergoing Axillary Lymph Node Dissection for Carcinoma Breast as compared to standard of care only. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075086

Enrollment

Registered

2024-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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: ALND + Lymphatico-venous Anastomosis: We will add Lymphatico-venous anastomosis to patients undergoing ALND and follow up with standard of care Control Intervention1: ALND: We will perf

Eligibility

Inclusion criteria

Inclusion criteria: All female patients planned for ALND whether post NACT or in upfront setting.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the presence of Lymphedema of upper limb on the operated side at 6 months. Timepoint: 2 weeks, 4 weeks, 8 weeks, 16 weeks, 20 weeks and 6 months	—

Secondary

Measure	Time frame
1. Assessment of quality of life by EORTC questionnaire C30/+BR23. 2. Surgical site infection 3. Development of seroma 4. Arm and shoulder pain 5. Anaesthesia/paraesthesia of inner side of arm and/ or chest wall 6. Episodes of cellulitis and DLA in the operated upper limb.Timepoint: 2 weeks, 4 weeks, 8 weeks, 16 weeks, 20 weeks and 6 months	—

Countries

India

Contacts

Public ContactDr Siddhant Karan

All India Institute of Medical Sciences, New Delhi

dranitadharbhan@gmail.com9810198239

Outcome results

None listed

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