Contact information
Type
Scientific
Primary contact
Dr Ranko Lazovic
ORCID ID
Contact details
Clinical Center of Montenegro
Podgorica
81000
Montenegro
drlazovic@t-com.me
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Primary repair of colon injuries: a comparison between a retrospective group managed by primary repair or two stage procedure and a prospective group managed by primary repair without using exclusion criteria
Acronym
Study hypothesis
Primary repair of colon injuries is possible in most cases without increased mortality and morbidity.
Ethics approval
Ethics Committee of Clinical Centre of Montenegro approved on the 2nd March 2002
Study design
Interventional randomised comparison between retrospective and prospective groups
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colon trauma
Intervention
This study was designed as retrospective and prospective evaluation of primary repair procedures in colon trauma management. Retrospective (RS) group included 30 patients (25 males and 5 females) with colon injury, treated in the Clinical Centre of Montenegro (CCM), Podgorica, in period 1995 - 2000. All patients in this group had war injuries and in all cases selective approach was used for the decision about the method of repair. Prospective (PR) group included 33 patients (29 males and 4 females) managed by the same surgical team. In this group, exclusion criteria were not used, with intention for primary repair in every case.
Patients were followed up to 30 days and mortality and morbidity were recorded as primary and secondary end points.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Mortality, data collected 30 days after the operation
Secondary outcome measures
Morbidity, data collected 30 days after the operation
Overall trial start date
01/01/1995
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients greater than 18 years old (either sex) with colon injury
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Patients less than 18 years old
Recruitment start date
01/01/1995
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Montenegro
Trial participating centre
Clinical Center of Montenegro
Podgorica
81000
Montenegro
Sponsor information
Organisation
Clinical Center of Montenegro (Montenegro)
Sponsor details
c/o Lazovic Ranko
Podgorica
81000
Montenegro
drlazovic@t-com.me
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded trial (Montenegro)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21126337
Publication citations
-
Results
Lazovic RG, Barisic GI, Krivokapic ZV, Primary repair of colon injuries: clinical study of nonselective approach., BMC Gastroenterol, 2010, 10, 141, doi: 10.1186/1471-230X-10-141.