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 |
| Protocol serial number | OG 99-030 |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: OG 99-30) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled multicentre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Recurrence of carcinoma after 5 years follow-up |
| Key secondary outcome measure(s) |
1. Determinants of failure after 5 years of follow-up, tested with Cox regression analysis |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 612 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
