Primary repair of colon injuries: a clinical study of non-selective aproach
| ISRCTN | ISRCTN94682396 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94682396 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/09/2010
- Registration date
- 26/10/2010
- Last edited
- 06/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ranko Lazovic
Scientific
Scientific
Clinical Center of Montenegro
Podgorica
81000
Montenegro
| drlazovic@t-com.me |
Study information
| Study design | Interventional randomised comparison between retrospective and prospective groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Primary repair of colon injuries is possible in most cases without increased mortality and morbidity. |
| Ethics approval(s) | Ethics Committee of Clinical Centre of Montenegro approved on the 2nd March 2002 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Mortality, data collected 30 days after the operation |
| Secondary outcome measures | Morbidity, data collected 30 days after the operation |
| Overall study start date | 01/01/1995 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Patients greater than 18 years old (either sex) with colon injury |
| Key exclusion criteria | Patients less than 18 years old |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Montenegro
Study participating centre
Clinical Center of Montenegro
Podgorica
81000
Montenegro
81000
Montenegro
Sponsor information
Clinical Center of Montenegro (Montenegro)
Hospital/treatment centre
Hospital/treatment centre
c/o Lazovic Ranko
Podgorica
81000
Montenegro
| drlazovic@t-com.me |
Funders
Funder type
Other
Investigator initiated and funded trial (Montenegro)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/12/2010 | Yes | No |
