Surgical excision versus Mohs micrographic surgery for primary and recurrent basal cell carcinoma of the face
| ISRCTN | ISRCTN65009900 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65009900 |
| Secondary identifying numbers | OG 99-030 |
- Submission date
- 15/10/2008
- Registration date
- 27/10/2008
- Last edited
- 21/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nicole Kelleners-Smeets
Scientific
Scientific
P. Debyelaan 25
Maastricht
6202 AZ
Netherlands
| n.kelleners.smeets@mumc.nl |
Study information
| Study design | Randomised controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | MP |
| Study objectives | Mohs micrographic surgery (MMS) is superior to surgical excision in recurrence rate. |
| Ethics approval(s) | Medical Ethics Committee of the Maastricht University on the 20th October 1999 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/1999 |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 408 (primary basal cell carcinoma) and 204 (recurrent basal cell carcinoma) |
| Key inclusion criteria | 1. Primary or first or second recurrent basal cell carcinoma 2. Aged 18 years or older, either sex |
| Key exclusion criteria | Expected life-duration of less than 3 years |
| Date of first enrolment | 01/11/1999 |
| Date of final enrolment | 01/02/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P. Debyelaan 25
Maastricht
6202 AZ
Netherlands
6202 AZ
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
P.O. Box 93245
Den Haag
2509 AE
Netherlands
| info@zonmw.nl | |
| Website | http://www.zonmw.nl |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: OG 99-30)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results: | 01/11/2004 | Yes | No | |
| Results article | results | 01/11/2014 | Yes | No |
