Condition category
Digestive System
Date applied
06/09/2010
Date assigned
26/10/2010
Last edited
06/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes