Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
16/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Emma Noble

ORCID ID

Contact details

c/o Mr K Hosie Secretary
Level 07
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
+44 (0)7968919208
em2_whitehead@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0185168728

Study information

Scientific title

Acronym

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

Cornwall and Plymouth Research Ethics Committee (UK), August 2005, REC no: 05/Q2103/71

Study design

Three-way randomised comparison trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Primary outcome measures

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 trial start date

31/08/2005

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

90 patients will be recruited, 30 will be randomised to each group.

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

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Mr K Hosie Secretary
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Plymouth Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes