Status Approved
First Submitted Date
2019/12/27
Registered Date
2020/01/23
Last Updated Date
2020/01/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004644 |
---|---|
Unique Protocol ID | HP IRB 2019-05-002-001 |
Public/Brief Title | Clinical outcomes and effect of delayed intervention in patients with small bowel perforation due to blunt abdominal trauma: A retrospective, observational analysis |
Scientific Title | Clinical outcomes and effect of delayed intervention in patients with small bowel perforation due to blunt abdominal trauma: A retrospective, observational analysis |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | HP IRB 2019-05-002-001 |
Approval Date | 2019-10-21 |
Institutional Review Board Name | Inje University Haeundae Paik Hospital IRB |
Institutional Review Board Address | 875, Haeun-daero, Haeundae-gu, Busan |
Institutional Review Board Telephone | 051-797-2747 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Ki Hoon Kim |
Title | Associate prof. |
Telephone | +82-51-797-0522 |
Affiliation | Inje University Haeundae Paik Hospital |
Address | 875, Haeundaero, Haeundaegu, Busan, Korea |
Contact Person for Public Queries | |
Name | Ki Hoon Kim |
Title | Associate prof. |
Telephone | +82-51-797-0522 |
Affiliation | Inje University Haeundae Paik Hospital |
Address | 875, Haeundaero, Haeundaegu, Busan, Korea |
Contact Person for Updating Information | |
Name | Ki Hoon Kim |
Title | Associate prof. |
Telephone | +82-51-797-0522 |
Affiliation | Inje University Haeundae Paik Hospital |
Address | 875, Haeundaero, Haeundaegu, Busan, Korea |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2019-10-22 Actual | |
Target Number of Participant | 52 | |
Primary Completion Date | 2019-11-21 , Actual | |
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Inje University Haeundae Paik Hospital | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2019-10-22 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Inje University Haeundae Paik Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Inje University Haeundae Paik Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Small bowel injury is reportedly the third most common injury in blunt abdominal trauma. As reported in a previous multicentric study, it was diagnosed in 1.1% of patients admitted with a history of blunt abdominal trauma, of which, only 0.3% patients were found to have a small bowel perforation. Investigations including abdominal X-ray, ultrasonography, peritoneal lavage, computed tomography (CT), and exploratory laparoscopy have been traditionally used to evaluate the extent of injuries following blunt abdominal trauma. CT is the currently accepted standard imaging modality, not only for the diagnosis of an abdominal solid organ injury, but also for evaluating suspected trauma involving hollow viscera, in an otherwise hemodynamically stable patient. The abdominal radiographic findings most often correlated with a diagnosis of small bowel injury include the presence of free intraperitoneal gas or fluid, enhanced bowel-wall thickness, mesenteric fat stranding, and detection of extra-luminal gas. Initial CT scan failed to detect ~15% of small bowel injures, though it has been found to be efficient and accurate for evaluating blunt trauma patients. There is still controversy surrounding the topic of how reliably CT by itself could help identify a blunt injury to the bowel that required surgical repair. The low incidence of small bowel injury and difficulty in diagnosis can result in delayed surgical intervention. A diagnostic delay of >24 h correspondingly increases morbidity and mortality due to the injury. While certain studies have suggested an association between increased morbidity and mortality and a diagnostic wait of even <5-8 h, some other reports claim that a delay in either the diagnosis or treatment of blunt bowel injury does not correlate with an increased incidence of subsequent complications. The purpose of this study was to determine whether the time-interval to operative treatment had any impact on the outcomes of patients who underwent surgery for blunt small bowel perforation. We performed not only a comparative analysis based on an 8-h delay, but also evaluated treatment outcomes in patients operated after a 24-h interval. This study was approved by the Research Ethics Board of my hospital. The data of all adult patients presenting with blunt abdominal injury, identified through the trauma database of a single regional hospital between March 2010 and December 2018, were collated for the study. The inclusion criteria were age >18 years and admission to the emergency department for blunt abdominal trauma during the study period. Data of patients who did not undergo abdominal organ surgery, who expired in <1 day of admission, for whom an abdominopelvic CT scan was not performed on admission in the ED, who underwent other abdominal organ repair in the presence or absence of associated small bowel injury, and who were operated only for mesenteric repair were excluded from the study. Finally, the study patients were divided into 3 groups of ≤8 h, 8-24 h, and >24 h, depending on the time-interval between injury and receiving operative intervention. And the outcome was also analyzed by divided into 2 groups of ≤24h and >24h according to time interval. Relevant variable factors were compared in each group. All patients’ hospital charts as well as their information from the database were reviewed and analyzed. Utilizing the ED database, every patient’s particulars including demographic characteristics, mechanism of injury, admission GCS score, time-interval from injury to OR transfer, time-interval between transfer from ED to OR, AIS code, ISS, clinical examination findings, laboratory and CT results, BIPS, whether small bowel resection was performed during operative abdominal exploration, LOS, ICU LOS, and mortality and morbidity data were identified and collated. Mortality was defined as death occurring at any time during the entire LOS, after the first 24 h of hospitalization. The recorded clinical findings include |
---|
8. Study Design
Study Type | Observational Study |
---|---|
Observational Study Model | Case-only |
Time Perspective | Retrospective |
Target Number of Participant | 52 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label blunt trauma small bowel perforation patient |
Cohort/Group Description The data of all adult patients presenting with blunt abdominal injury, identified through the trauma database of a single regional hospital between March 2010 and December 2018, were collated for the study. The inclusion criteria were age >18 years and admission to the emergency department for blunt abdominal trauma during the study period. Data of patients who did not undergo abdominal organ surgery, who expired in <1 day of admission, for whom an abdominopelvic CT scan was not performed on admission in the ED, who underwent other abdominal organ repair in the presence or absence of associated small bowel injury, and who were operated only for mesenteric repair were excluded from the study. Finally, the study patients were divided into 3 groups of ≤8 h, 8-24 h, and >24 h, depending on the time-interval between injury and receiving operative intervention. And the outcome was also analyzed by divided into 2 groups of ≤24h and >24h according to time interval. Relevant variable factors were compared in each group |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | The data of all adult patients presenting with blunt abdominal injury, identified through the trauma database of a single regional hospital between March 2010 and December 2018, were collated for the study. |
---|---|
Sampling Method | According to non-probablity sampling, the inclusion criteria were age >18 years and admission to the emergency department for blunt abdominal trauma during the study period. Data of patients who did not undergo abdominal organ surgery, who expired in <1 day of admission, for whom an abdominopelvic CT scan was not performed on admission in the emergency department (ED), who underwent other abdominal organ repair in the presence or absence of associated small bowel injury, and who were operated only for mesenteric repair were excluded from the study. Finally, the study patients were divided into 3 groups of ≤8 h, 8-24 h, and >24 h, depending on the time-interval between injury and receiving operative intervention |
Condition(s)/Problem(s) |
* (S00-T98)Injury, poisoning and certain other consequences of external causes (S39.9)Unspecified injury of abdomen, lower back and pelvis Blunt abdominal trauma; Small bowel perforation; delayed intervention |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~100Year |
|
Description age >18 years and admission to the emergency department for blunt abdominal trauma |
|
Exclusion Criteria |
who did not undergo abdominal organ surgery, who expired in <1 day of admission, for whom an abdominopelvic CT scan was not performed on admission in the emergency department (ED), who underwent other abdominal organ repair in the presence or absence of associated small bowel injury, and who were operated only for mesenteric repair were excluded from the study. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | clinical-equivalence | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | clinical outcome(morbidity, mortality) |
|
Timepoint | time of discharge |
|
Secondary Outcome(s) 1 | ||
Outcome | analysis of baseline chanracteristics, outcome of surgery |
|
Timepoint | time of discharge |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동