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Study Title and Description

Cosmetic results of cryosurgery versus surgical excision for primary uncomplicated basal cell carcinomas of the head and neck.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Cosmetic results of cryosurgery versus surgical excision for primary uncomplicated basal cell carcinomas of the head and neck.
Author Thissen MR., Nieman FH., Ideler AH., Berretty PJ., Neumann HA.
Country Departments of Dermatology and Clinical Epidemiology, University Hospital Maastricht, The Netherlands. mthis@sder.azm.nl
Year 2000
Numbers Pubmed ID: 10940063

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 cryotherapy
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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 superficial or nodular BCCs, clinically smaller than 2 cm in diameter, localized anywhere in the head and neck area
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Exclusion criteria recurrent BCCs, histologic subtypes different from the nodular or superficial subtype, tumors larger than 2 cm in diameter, patients with five or more BCCs, and contraindications to surgery or cryosurgery (eg, cold intolerance). Patients with a life expectancy of less than 1 year were also excluded.
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N Enrolled/Randomized/Analyzed 96
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96
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96
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Notes/Comments
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Method of diagnosis ... Describe Other ... NR
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Preoperative assessment of clinical size of the tumor ... visual ... Before treatment, the tumors were documented with photographs (SA­300N autofocus reflex camera/zoom lens, Sigma, Japan; Kodak ISO 200­DX film) at two standard distances (detail and overview), using standard illumination
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Percent non-primary (recurrent)
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Secondary size assessment
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Baseline Characteristics
Question cryotherapy surgical excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 68
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13
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Gender/Racial descent NR NR
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Lesion location 22 20
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46 43
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2 4
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4 8
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2 0
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4 7
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3 14
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6 Forehead/temple: 12 (25%) Chin/perioral: 5 (10%)
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Forehead/temple: 16 (34%) Chin/perioral: 3 (6%)
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 48 48 NR
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100 100
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NR NR
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 48 48 4
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three patients did not appear for control visits and one patient died (not related to the tumor treated in this study)
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96
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103
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Lesion extent number of people 8 6
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40 42
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Adverse events: other      Population: All Participants
Time Point Measure cryotherapy surgical excision


2 weeks

N Analyzed 48 48
Counts 3 2
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure cryotherapy surgical excision


1 years

N Analyzed 48 48
Counts 3 0




N Analyzed
Counts
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure cryotherapy surgical excision


soon after surgery N/A

N Analyzed 48 48
Counts 0 42
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure cryotherapy surgical excision


soon after surgery N/A

N Analyzed 48 48
Counts 42 48
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure cryotherapy surgical excision


soon after surgery N/A

N Analyzed 48 48
Counts 0 0
Outcome: Cosmetic outcome (continuous)      Population: All Participants
Time Point Measure cryotherapy surgical excision


soon after surgery N/A

N Analyzed 48 48
Mean 7.58 8.87
SD 1.04 0.86
SE


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data
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RCT:....Adequate allocation concealment reported No Data
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RCT:....Adequate blinding of PATIENTS reported No Not possible to blind patients to treatment allocation (cryosurgery vs. surgical excision)
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RCT:....Adequate blinding of PROVIDERS reported No Data It is not reported if providers were blinded, might be high RoB for clinical recurrence outcome
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Unsure cosmetic results were independently assessed by 5 professionals who were "not involved in the trial and who were blinded to the treatment"
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No Clearance is fully reported by arm.
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ALL.....Selective Reporting (judgement - put directly into notes field). No
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RCT.....Is the treatment effect by Intention to treat? Yes few drop-outs not reported by arm (3 did not appear for control visits and 1 died), not related to treatment or outcome
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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) Yes Clearance outcome could be affected by lack of blinding of providers. Cosmetic outcome is fine because assessors were blinded.
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes AEs: secondary wound infections; moderate to severe swelling of treated area. (Reported by Arm)
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Overall, by outcome (judgement - put directly into notes field) Moderate to high RoB because of blinding only
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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
Guideline Used Overall Rating