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A Study Comparing Two Different Surgical Instruments in Breast Cancer Surgery

A Randomized Controlled Trial Comparing Ultrasonic Dissection With Electrocautery For Axillary Dissection In Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004575
Enrollment
138
Registered
2014-04-28
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: null- Carcinoma of Breast

Interventions

Intervention1: Ultrasonic dissection: Harmonic ultrasonic dissector. It is used in sugery for dissection. Here in this study it will be used for axillary dissection. Control Intervention1: Electrocaut

Sponsors

Dr Arun Peter Mathew
Lead Sponsor
Dr Madhu Muralee
Collaborator
Dr Siva Ranjith J
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All female patients with proven carcinoma breast, undergoing Axillary lymph node dissection Patient willing to give a valid consent for the use of Ultrasonic Dissection

Exclusion criteria

Exclusion criteria: Age more than 70yrs Patients undergoing reconstructive procedures Previous axillary surgeries

Design outcomes

Primary

MeasureTime frame
We hypothesize that axillary lymph node dissection (ALND) performed with Ultrasonic Dissection will decrease post operative drain volume and number of days on drain. Total post operative drainage â?? Defined as cumulative drain volume in the drain bellow from post operative day one till the day of drain removal. This would be charted out by the patient / bystander in a format given to the patient at the time of discharge. Total number of days with drainTimepoint: Twenty months

Secondary

MeasureTime frame
Operative Time â?? Defined as the time from the start of incision to the start of skin suturing/stapling Drain on first postoperative day Hematoma in the postoperative period â?? Defined as post operative haematoma warranting an exploration Seroma development after drain removal â?? defined as any collection in the axilla, developing after the drain removal and requiring an aspiration. Wound complications Delay in starting adjuvant treatment Timepoint: 20 months

Countries

India

Contacts

Public ContactDr Siva Ranjith J

Regional Cancer Center

sivaranjith.j@gmail.com9895234986

Outcome results

None listed

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