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Study Title and Description

Surgical excision versus Mohs; micrographic surgery for primary and recurrent basal-cell carcinoma of the face: a prospective randomised controlled trial with 5-years; follow-up.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Surgical excision versus Mohs; micrographic surgery for primary and recurrent basal-cell carcinoma of the face: a prospective randomised controlled trial with 5-years; follow-up.
Author Mosterd K., Krekels GA., Nieman FH., Ostertag JU., Essers BA., Dirksen CD., Steijlen PM., Vermeulen A., Neumann H., Kelleners-Smeets NW.
Country Department of Dermatology, Maastricht University Medical Centre, Maastricht, Netherlands.
Year 2008
Numbers Pubmed ID: 19010733

Secondary Publication Information
UI Title Author Country Year
Surgical excision versus Mohs' micrographic surgery for basal cell carcinoma of the face: A randomised clinical trial with 10 year follow-up. van Loo E., Mosterd K., Krekels GA., Roozeboom MH., Ostertag JU., Dirksen CD., Steijlen PM., Neumann HA., Nelemans PJ., Kelleners-Smeets NW. Maastricht University FHML, P.O. Box 616, 6200 MD Maastricht, Netherlands. 2014
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Surgical excision vs Mohs' micrographic surgery for basal-cell carcinoma of the face: randomised controlled trial. Smeets NW., Krekels GA., Ostertag JU., Essers BA., Dirksen CD., Nieman FH., Neumann HA. Department of Dermatology, University Hospital Maastricht, Maastricht, Netherlands. nsme@sder.azm.nl -- Not Found --
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Cost-effectiveness of Mohs Micrographic Surgery vs Surgical Excision for Basal Cell Carcinoma of the Face. Essers BA., Dirksen CD., Nieman FH., Smeets NW., Krekels GA., Prins MH., Neumann HA. Department of Clinical Epidemiology and Medical Technology Assessment, University Hospital Maastricht, The Netherlands. bes@kemta.azm.nl 2006
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Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 MMS
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2 Surgical excision
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design RCT
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Multicenter etc. Multicenter
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Country/Region Netherlands
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Funding No industry support
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Inclusion criteria >= 1 untreated, histologically conformed primary BCC of at least 1cm in diameter located in the H-zone or a or a facial primary BCC of an aggressive histological subtype (ie, morpheaform, micronodular, trabecular, infiltrative, or BCC with squamous differentiation)
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Exclusion criteria life-expectancy of less than 3 years
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N Enrolled/Randomized/Analyzed 443
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374
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251
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... visual ... overall and close-up photographs were taken before each treatment
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question MMS Surgical excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 67.4 68.7
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12.7 12.2
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13.76mm 15.97mm
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6.43mm 8.17mm
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1.28cm2 1.77cm2
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1.36cm2 1.28cm2
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Gender/Racial descent 81 78
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39.7 38.2
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Lesion location 204 204
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100 100
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Frontal/temporal 53 (26%) Cheek/chin 19 (9%) (Peri)nasal 69 (34%) Lips/perioral 14 (7%) Periocular 16 (8%) Ears 9 (4%) Periauricular 24 (12%) Frontal/temporal 65 (32%) Cheek/chin 16 (8%) (Peri)nasal 62 (30%) Lips/perioral 8 (4%) Periocular 16 (8%) Ears 16 (8%) Periauricular 21 (10%)
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 342
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91
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30
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8
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2
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1
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 198 199 443
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204 204 486
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374
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408
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83 patients with 92 tumours (23%) died of causes not related to the tumour or to the treatment. A further 35 tumours (9%) in 30 patients were lost to follow-up due to other reasons, such as an inability to visit the hospital, moving out, or refusing further follow-up at our department.
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251 (at 5 y)/129 (at 10 y)
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270 (at 5 y)/140 (at 10 y)
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Lesion extent number of people 204 (100%) 204 (100%)
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105 (51.5%) 88 (43.1%)
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aggressive: morpheaform, micronodular, trabecular, infi ltrative, or BCC with squamous differentiation aggressive: morpheaform, micronodular, trabecular, infi ltrative, or BCC with squamous differentiation
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Incomplete excision      Population: All Participants
Time Point Measure MMS Surgical excision


after first excision years

N Analyzed 198 199
Counts 0 35


after second excision years

N Analyzed NA 31
Counts NA 4
Outcome: Incomplete excision      Population: Aggressive
Time Point Measure MMS Surgical excision


after first excision years

N Analyzed 105 88
Counts 0 21
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure MMS Surgical excision


after first excision years

N Analyzed 198 199
Counts 24 28
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure MMS Surgical excision


24 months

N Analyzed 171 176
Counts 2 3


48 months

N Analyzed 140 139
Counts 1 3


60 months

N Analyzed 161 166
Counts 1 1


72 months

N Analyzed 106 117
Counts 1 1


96 months

N Analyzed 79 89
Counts 1 3


120 months

N Analyzed 71 69
Counts 0 4


>120 months

N Analyzed 71 69
Counts 2 2
Outcome: Long-term Mortality      Population: All Participants
Time Point Measure MMS Surgical excision


5 years

N Analyzed 198 199
Counts 34 36
Outcome: Quality of life (generic)      Population: All Participants
Time Point Measure MMS Surgical excision


0 months

N Analyzed 45 65
Mean 8.88 8.54
SD 13.93 14.13
SE


6 months

N Analyzed 45 65
Mean 8.88 9.74
SD 15.81 16.37
SE
Outcome: Quality of life (generic)      Population: All Participants
Time Point Measure MMS Surgical excision


0 months

N Analyzed 45 65
Mean 11.85 15.38
SD 25.78 28.31
SE


6 months

N Analyzed 45 65
Mean 9.6 21.02
SD 22.04 33.62
SE
Outcome: Quality of life (generic)      Population: All Participants
Time Point Measure MMS Surgical excision


0 months

N Analyzed 45 65
Mean 11.94 12.3
SD 22.91 22.91
SE


6 months

N Analyzed 45 65
Mean 11.38 13.84
SD 21.29 22.65
SE
Outcome: Quality of life (generic)      Population: All Participants
Time Point Measure MMS Surgical excision


0 months

N Analyzed 45 65
Mean 11.55 17.84
SD 24.30 27.18
SE


6 months

N Analyzed 45 65
Mean 14.66 13.23
SD 29.96 23.52
SE
Outcome: Quality of life (generic)      Population: All Participants
Time Point Measure MMS Surgical excision


0 months

N Analyzed 45 65
Mean 4.88 2.76
SD 10.57 6.96
SE


6 months

N Analyzed 45 65
Mean 3.11 2.76
SD 8.48 7.8
SE
Outcome: Quality of life (generic)      Population: All Participants
Time Point Measure MMS Surgical excision


0 months

N Analyzed 45 65
Mean 9.44 13.46
SD 19.61 23.52
SE


6 months

N Analyzed 45 65
Mean 10.83 15.96
SD 18.76 25.62
SE
Outcome: Quality of life (generic)      Population: All Participants
Time Point Measure MMS Surgical excision


0 months

N Analyzed 45 65
Mean 32.86 33.64
SD 9.99 9.67
SE


6 months

N Analyzed 45 65
Mean 29.77 31.69
SD 7.6 7.64
SE


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
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RCT:....Adequate allocation concealment reported Yes
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RCT:....Adequate blinding of PATIENTS reported Yes
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RCT:....Adequate blinding of PROVIDERS reported No
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes
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ALL.....Selective Reporting (judgement - put directly into notes field). Aesthetic outcomes only reported in combined recurrent/primary arm. Subgroup analysis for more severe cancers missing followup Ns;
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. Yes
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field)
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
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Overall, by outcome (judgement - put directly into notes field) Overall low to maybe moderate RoB because of loss to followup.
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
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Quality Rating
No quality rating data was found.