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

ISRCTN	ISRCTN62800654
DOI	https://doi.org/10.1186/ISRCTN62800654
Protocol serial number	N0185168728
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Plymouth Hospitals NHS Trust (UK), NHS R&D Support Funding (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mrs Emma Noble
Scientific

c/o Mr K Hosie Secretary
Level 07
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Phone	+44 (0)7968919208
Email	em2_whitehead@hotmail.com

Primary study design	Interventional
Study design	Three-way randomised comparison trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised three-way comparison of mastectomy performed using Lotus Ultrasonic Cutting and Coagulation Device, Ethicon Harmonic Scalpel or monopolar diathermy
Study objectives	Are the Lotus UCCD and Ethicon Harmonic Scalpel and monopolar diathermy equivalent to each other for tissue dissection during a mastectomy?
Ethics approval(s)	Cornwall and Plymouth Research Ethics Committee (UK), August 2005, ref: REC no: 05/Q2103/71
Health condition(s) or problem(s) studied	Surgery: Mastectomy
Intervention	Three-way randomised comparison trial: Lotus Ultrasonic Cutting and Coagulation Device, Ethicon Harmonic Scalpel or monopolar diathermy.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	90
Key inclusion criteria	Patients for routine, elective unilateral or bilateral mastectomy with or with out simultaneous axillary node dissection.
Key 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
Date of first enrolment	31/08/2005
Date of final enrolment	31/10/2007

c/o Mr K Hosie Secretary

Plymouth
PL6 8DH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

22/05/2017: No publications found in PubMed, verifying study status with principal investigator.