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
Secondary identifying numbers	N0185168728

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

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

Study design	Three-way randomised comparison trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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 hypothesis	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
Condition	Surgery: Mastectomy
Intervention	Three-way randomised comparison trial: Lotus Ultrasonic Cutting and Coagulation Device, Ethicon Harmonic Scalpel or monopolar diathermy.
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 outcome measures	Not provided at time of registration
Overall study start date	31/08/2005
Overall study end date	31/10/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	90 patients will be recruited, 30 will be randomised to each group.
Participant inclusion criteria	Patients for routine, elective unilateral or bilateral mastectomy with or with out simultaneous axillary node dissection.
Participant 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
Recruitment start date	31/08/2005
Recruitment end date	31/10/2007

c/o Mr K Hosie Secretary

Plymouth
PL6 8DH
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Plymouth Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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