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Study Title and Description

Surgical excision versus curettage plus cryosurgery in the treatment of basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Surgical excision versus curettage plus cryosurgery in the treatment of basal cell carcinoma.
Author Kuijpers DI., Thissen MR., Berretty PJ., Ideler FH., Nelemans PJ., Neumann MH.
Country Department of Dermatology, University Hospital of Maastricht, P. Debijelaan 25, 6202 AZ Maastricht, The Netherlands. Dku@sder.azm.nl
Year 2007
Numbers Pubmed ID: 17451581

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Curettage + Cryosurgery
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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. Single center
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Country/Region Netherlands
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Funding No industry support
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Inclusion criteria 18+ years old, untreated, primary histologically proven BCC, nodular and superficial type, on the head and neck, <20mm diameter
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Exclusion criteria Recurrent, histologic subtypes other than superficial and nodular, >20 mm diameter, contraindications to either procedure, presence of 5+ BCCs
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N Enrolled/Randomized/Analyzed 88
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88
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88
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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 ... not reported ...
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question Curettage + Cryosurgery Surgical excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 5.4 5.3 67
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2.9 2.6 67
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Size, mm (mean longest diameter) for each tumor Size, mm (mean longest diameter) for each tumor 34, 92
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Gender/Racial descent 38
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43
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Lesion location 40 37
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Forehead/temple, Cheek/chin, Periocular Forehead/temple, Cheek/chin, Periocular
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2 3
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Lips/mouth Lips/mouth
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4 3
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Ears/periauricular Ears/periauricular
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4 6
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Neck, chest/back Neck, chest/back
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 92
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6
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2
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 51 49
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51 49
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13 2
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9 due to unrelated death due to unrelated death
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51 49
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Lesion extent number of people 0 4
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51 45
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Incomplete excision      Population: All Participants Between-Arm Comparisons
Time Point Measure Curettage + Cryosurgery Surgical excision Comparison Measure


Enter a numeric value or title (required) N/A

Counts 3
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Curettage + Cryosurgery Surgical excision


1 years

Counts 4 0
N Analyzed 51 49
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Curettage + Cryosurgery Surgical excision


2 years

Counts 5 1
N Analyzed 51 49
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Curettage + Cryosurgery Surgical excision


3 years

Counts 7 2
N Analyzed 51 49
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Curettage + Cryosurgery Surgical excision


4 years

Counts 9 4
N Analyzed 51 49
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Curettage + Cryosurgery Surgical excision


5 years

Counts 9 4
N Analyzed 38 47
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Curettage + Cryosurgery Surgical excision


n/a N/A

Counts 3 4
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Curettage + Cryosurgery Surgical excision


5 years

Counts 0 0
Outcome: Number of repeat procedures      Population: All Participants
Time Point Measure Curettage + Cryosurgery Surgical excision


5 years

Counts 0 4


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 No Not possible
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RCT:....Adequate blinding of PROVIDERS reported No Not possible
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Unsure 3rd blinded party did assessments "where possible"
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes 13/51 tumors in the cryo group lost to follow-up 2/49 in surgical group
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ALL.....Selective Reporting (judgement - put directly into notes field). Missing systematic reporting of AEs
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RCT.....Is the treatment effect by Intention to treat? No Not true intention to treat, completer analysis
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ALL....Group similarity at baseline. Maybe 4 superficial BCC in surgery arm. All others nodular.
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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 No
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Overall, by outcome (judgement - put directly into notes field) Overall moderate to high due to missingness
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes Cryo group had 13 missing at 5 years vs. 2 in excision group
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Quality Rating
No quality rating data was found.