Condition category
Cancer
Date applied
15/10/2008
Date assigned
27/10/2008
Last edited
21/01/2015
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

Dr Nicole Kelleners-Smeets

ORCID ID

Contact details

P. Debyelaan 25
Maastricht
6202 AZ
Netherlands
-
n.kelleners.smeets@mumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OG 99-030

Study information

Scientific title

Examining the (cost-) effectiveness of Mohs micrographic surgery versus surgical excision in the treatment of primary and recurrent basal cell carcinoma: a prospective randomised study

Acronym

MP

Study hypothesis

Mohs micrographic surgery (MMS) is superior to surgical excision in recurrence rate.

Ethics approval

Medical Ethics Committee of the Maastricht University on the 20th October 1999

Study design

Randomised controlled multicentre 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

Primary or first or second recurrent basal cell carcinoma

Intervention

Arm 1: Mohs micrographic surgery -
Tumours were excised with a margin of 3 mm under an angle of 45 degrees. The complete resection margins of the excised material were investigated histopathologically on horizontal frozen section slides. In case of positive resection margins, the procedure was repeated, until total clearance was obtained. The duration of the procedure was dependent of the number of mohs stages. Primary and secondary outcome measures were measured after 5 years follow-up.

Arm 2: surgical excision -
Tumours were excised with a margin of 3 mm under an angle of 90 degrees. The histolopathological examination was performed on vertical slides. The duration of the procedure was approximately 45 minutes per treatment. Primary and secondary outcome measures were measured after 5 years follow-up.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Recurrence of carcinoma after 5 years follow-up

Secondary outcome measures

1. Determinants of failure after 5 years of follow-up, tested with Cox regression analysis
2. Cost-effectiveness after 5 years of follow-up an incremental cost-effectiveness ratio was calculated, all personal and material costs of both treatments that have been made during procedures and follow-up were calculated by multiplying volumes of use with the cost per unit

Overall trial start date

01/11/1999

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary or first or second recurrent basal cell carcinoma
2. Aged 18 years or older, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

408 (primary basal cell carcinoma) and 204 (recurrent basal cell carcinoma)

Participant exclusion criteria

Expected life-duration of less than 3 years

Recruitment start date

01/11/1999

Recruitment end date

01/02/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

P. Debyelaan 25
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

P.O. Box 93245
Den Haag
2509 AE
Netherlands
-
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: OG 99-30)

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

2004 results: http://www.ncbi.nlm.nih.gov/pubmed/15541449
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25262378

Publication citations

  1. Results

    Smeets NW, Krekels GA, Ostertag JU, Essers BA, Dirksen CD, Nieman FH, Neumann HA, Surgical excision vs Mohs' micrographic surgery for basal-cell carcinoma of the face: randomised controlled trial., Lancet, 364, 9447, 1766-1772, doi: 10.1016/S0140-6736(04)17399-6.

  2. Results

    van Loo E, Mosterd K, Krekels GA, Roozeboom MH, Ostertag JU, Dirksen CD, Steijlen PM, Neumann HA, Nelemans PJ, Kelleners-Smeets NW, Surgical excision versus Mohs' micrographic surgery for basal cell carcinoma of the face: A randomised clinical trial with 10 year follow-up, Eur J Cancer, 2014 , 50, 17, 3011-3020, doi: 10.1016/j.ejca.2014.08.018.

Additional files

Editorial Notes