The objective of this nonrandomized clinical trial study is to investigate the outcome of staged surgical excision with intraoperative histopathologic evaluation on high risk basal cell carcinoma. In this study 25 patients who histopathologically documented basal cell carcinoma and minimally had one risk factor were recruited and subjected to this method of treatment. First, depended on characteristics of lesion, 3-5 mm of marginal skin of tumor was excised and induced defect from surgical excision was open. The sample with special marking subjected to histopathologic routine assessment. In presented of malignant cells, repeated surgical excision with guiding of pathologic team was carried out, if not repaired induced defect. The patients were followed-up for recurrence in surgical site for 3 years and in the present of any doubt of recurrence biopsy and histopathologic assessment were done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412196403N5
Registration date:2015-02-25, 1393/12/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-25, 1393/12/06
Registrant information
Name
Hossein Kavoussi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1837 5424
Email address
hkawosi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment high risk basal cell carcinoma by staged surgery
Public title
Outcome of staged surgical excision with intraoperative histopathologic evaluation for treatment of high risk basal cell carcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria included: Pathologically documented basal cell carcinoma and minimally had one risk factor included, diameter more than 2 cm, recurrent lesions, high risk pathologic subtype, high risk location of lesions, morphoic clinical subtype
exclusion criteria included: immunodeficiency, pregnancy, age less than 15 and more than 70
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Scienses
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blvd
City
Kermanshah
Postal code
Approval date
2014-11-14, 1393/08/23
Ethics committee reference number
35215/420/7/پ
Health conditions studied
1
Description of health condition studied
basal cell carcinoma
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
recurrence
Timepoint
monthly in first year and 3 month thereafter
Method of measurement
Clinical and pathologic assesment
Secondary outcomes
1
Description
Healing
Timepoint
monthly in first year and 3 month thereafter
Method of measurement
clinical and pathologic assesment
Intervention groups
1
Description
staged surgical excision with intraoperative pathologic assesment
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajdaie clinic
Full name of responsible person
Hossein Kavoussi
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences , Shahid Beheshty Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Ebrahimi
Position
Assistant professsor
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
Phone
+98 83 3837 5424
Fax
Email
aebrahimi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Kavoussi
Position
Medical student
Other areas of specialty/work
Street address
Medical school, Daneshgah Ave
City
Kermanshah
Postal code
Phone
+98 83 3825 9212
Fax
Email
kavoussi_1389@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)