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
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
-
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.
-
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.