Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/01/2015
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

Mr L Yap

ORCID ID

Contact details

Burns & Plastics
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265166244

Study information

Scientific title

Sensate DIEP flaps - assessment of breast sensation on quality of life and body image

Acronym

Study hypothesis

1. To assess how important breast sensation is to patients undergoing breast reconstruction both pre and post operatively and the degree that this impacts on patient quality of life and body image
2. To assess the recovery of sensation in a breast reconstructed with abdominal skin and nerve reattachment, and to compare this to a breast reconstructed with abdominal skin that has not had the nerve reattached, and a bust reconstructed with skin/muscle from the back

Ethics approval

Not provided at time of registration

Study design

Randomised controlled 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: Breast

Intervention

Patients preparing for an excision of breast cancer and reconstruction are seen pre-operatively and followed up in our breast reconstruction clinic. These patients are counselled as to the expected loss of breast sensation following surgery. They are then offered a choice of reconstructive options, which include:
1. Implant only
2. Skin and muscle from the back
3. Skin and muscle from the stomach (+ or - nerve reattachment

We intend to ask all patients within these three groups how important they think breast sensation is to them before the operation. We also wish to obtain validated measures of anxiety and depression and body image,
Following the Operation. We will repeat the questionnaire and body Image assessment to establish how much this does impact upon their everyday life and how much sensory return they achieve. This will be repeated at each clinic visit (3 monthly) for 1 year.

The patients who are having reconstructions from their abdominal skin and muscle will be randomised into two groups: those receiving nerve reattachment and those not having nerve reattachment. At present the nerve is reattached occasionally, if it is deemed easy 10 perform intra-operatively. The vast majority of patients do not have the nerve reattached. It will add 30-60 minutes to the operation time. The study will be double blinded.

The questionnaire is a VAS addressing the impact of sensation upon quality of life. The wording has been finalised after speaking to a group of patients attending the clinic.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

24/06/2005

Overall trial end date

24/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All patients attending the breast reconstruction clinic for one of the three types of breast reconstruction will be seen at the clinic and asked if they wish to participate in the research. They will not have to attend any extra clinics. The questionnaire will simply be given out whilst they are in the waiting room and can be completed before they are called in to see the doctor.
Those patients who are having reconstruction with abdominal skin and muscle will be informed of the procedure to reattach the nerve and asked if they would be happy to be randomised into nerve reattachment or no nerve reattachment.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

24/06/2005

Recruitment end date

24/03/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Selly Oak Hospital
Birmingham
B29 6JD
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

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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