A randomised three-way comparison of mastectomy performed using Lotus Ultrasonic Cutting and Coagulation Device, Ethicon Harmonic Scalpel or monopolar diathermy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62800654

Enrollment

Registered

2006-09-29

Start date

2005-08-31

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

Surgery: Mastectomy Surgery Mastectomy

Interventions

Three-way randomised comparison trial: Lotus Ultrasonic Cutting and Coagulation Device, Ethicon Harmonic Scalpel or monopolar diathermy.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients for routine, elective unilateral or bilateral mastectomy with or with out simultaneous axillary node dissection.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women 2. Patients under 18 years 3. Patients above 75 years 4. History of coagulation abnormality 5. Inability to understand the nature of this study

Design outcomes

Primary

Measure	Time frame
Post-operative drainage. 1. Blood loss 2. Duration of operation 3. Extent of collateral tissue damage 4. Opinion of operating surgeon 5. Post-operative pain 6. Duration of post-operative hospital stay 7. Seroma and infection rates	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

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