Condition category
Surgery
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
21/08/2009
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

Dr Steve George

ORCID ID

Contact details

University of Southampton Clinical Trials Unit
Mailpoint 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 6533
pluto@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 95/25/03

Study information

Scientific title

A prospective randomised comparison of minor surgery in primary and secondary care

Acronym

MiSTIC (Minor Surgery Trial In the Community)

Study hypothesis

Increasingly with the move towards a "primary care led NHS" services previously provided within hospitals are being provided within primary care settings. One such service is minor surgery. Although minor surgery is widely practised in primary care it has not been subjected to critical analysis in a randomised study in terms of its safety, quality and cost effectiveness. This study is a prospective, randomised controlled trial comparing the treatment of minor surgical conditions in primary and secondary care in terms of these variables.

Please note that the target number of participants was added as of 02/12/2008.

Ethics approval

South and West Regional Research Ethics Committee, approved on 06/10/1999 (ref: 092/99)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Lesions requiring minor surgery (predominantly skin)

Intervention

Interventions amended as of 02/12/2008:
Elective minor surgeries in the categories described in the participants inclusion criteria field, delivered either in primary care, by the patient's own GP or by referral to a primary care colleague, or in hospital, by either surgeons or dermatologists at a variety of grades.

Previous interventions:
Quality of surgery performed in primary care vs surgery performed in hospital

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Primary outcome measures amended as of 02/12/2008:
Quality of treatment measured using cosmetic results of surgery.

Previous primary outcome measures:
Safety, quality and cost effectiveness.

Secondary outcome measures

Added as of 02/12/2008:
1. Extent to which samples were sent for histology
2. Completeness of excision of malignant lesions
3. Patient satisfaction with aspects of care

Overall trial start date

01/05/1999

Overall trial end date

30/04/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria amended as of 02/12/2008:
All patients (both genders, no age limits) with one of a range of conditions amenable to minor surgery who were considered suitable for treatment by a participating GP or one of their partners. The study focuses on four categories of minor surgical treatment; excisions, incisions, aspirations and "other", including removal of foreign bodies.

Previous inclusion criteria:
Patients requiring minor surgery.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

490

Participant exclusion criteria

Added as of 02/12/2008:
1. Patients whom operating doctor considered too complex for treatment in primary care
2. Patients requiring cautery
3. Patients requiring injections for the treatment of painful joints

Recruitment start date

01/05/1999

Recruitment end date

30/04/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton Clinical Trials Unit
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0) 23 8059 5000
rgoinfo@soton.ac.uk

Sponsor type

University/education

Website

http://www.soton.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18505669

Publication citations

  1. Results

    George S, Pockney P, Primrose J, Smith H, Little P, Kinley H, Kneebone R, Lowy A, Leppard B, Jayatilleke N, McCabe C, A prospective randomised comparison of minor surgery in primary and secondary care. The MiSTIC trial., Health Technol Assess, 2008, 12, 23, iii-iv, ix-38.

Additional files

Editorial Notes