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A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma

NCT ID: NCT00571363

Last Updated: 2007-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-12-31

Brief Summary

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We have compared to types of surgery to assess which one leaves the smaller surgical defect.

Detailed Description

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Patients with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 centimetre and 1 centimetre away from eyes, nose and ears were either randomized to undergo Mohs Micrographic Surgery or standard surgical excision. After the tumour had been removed the defect was measured.

Conditions

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Carcinoma, Basal Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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standard surgery

basal cell carcinomas were excised with 4 mm margins

Group Type ACTIVE_COMPARATOR

standard surgery

Intervention Type PROCEDURE

excision with 4 mm margins

Mohs

Basal cell carcinoma were removed via Mohs Micrographic surgery

Group Type ACTIVE_COMPARATOR

Mohs micrographic surgery

Intervention Type PROCEDURE

excision of basal cell carcinoma with 2 mm margins and immediate examination of margins for residual tumour. residual tumour was excised until complete tumour removal was achieved.

Interventions

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standard surgery

excision with 4 mm margins

Intervention Type PROCEDURE

Mohs micrographic surgery

excision of basal cell carcinoma with 2 mm margins and immediate examination of margins for residual tumour. residual tumour was excised until complete tumour removal was achieved.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 cm, 1 cm away from eye, nose or ears

Exclusion Criteria

* Subjects of less than 18 years of age
* Subjects unable to comply with instructions,
* Immunosuppressed subjects
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Tayside

OTHER_GOV

Sponsor Role lead

Responsible Party

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NHS Tayside,

Principal Investigators

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Frank M Muller

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside

Locations

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Ninewells Hospital and Medical School

Dundee, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Muller FM, Dawe RS, Moseley H, Fleming CJ. Randomized comparison of Mohs micrographic surgery and surgical excision for small nodular basal cell carcinoma: tissue-sparing outcome. Dermatol Surg. 2009 Sep;35(9):1349-54. doi: 10.1111/j.1524-4725.2009.01240.x. Epub 2009 Jun 3.

Reference Type DERIVED
PMID: 19500127 (View on PubMed)

Other Identifiers

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R&D Project ID: 2003DS10

Identifier Type: -

Identifier Source: secondary_id

2003DS10

Identifier Type: -

Identifier Source: org_study_id