The objective of this review is to develop a more reliable overall assesment of the injury and clinical factors predictive of secondary amputation in patients with traumatic lower limb vascular injuries.
a) Electronic Databases: MEDLINE, EMBASE, CINAHL
b) Manual search of relevant reference lists
a) Date: 01/01/2000 - 01/06/2012
c) Language: English
Types of study to be included
Cohort studies, observational studies, case series with greater than 5 patients; systematic reviews.
Case series with 5 or less patients; case reports; narrative/expert reviews, letters and editorials.
Condition or domain being studied
Trauma is the leading cause of death and disability in societies' young and most active members. Severe lower limb injuries, including limb amputations, are an important source of this disability. Secondary amputations are amputations performed after an initial attempt to salvage the limb.
a) Adult patients (>16 years), AND
b) Acute traumatic injury, AND
c) Lower limb major vascular injury (external iliac to tibial vessels), AND
d) Attempted surgical repair using standard vascular surgery techniques.
b) Not an acute traumatic injury: iatrogenic injuries, pathological changes following spinal injury, longstanding complications of traumatic vascular injuries, peripheral vascular disease.
c) Non-surgical management: Injuries treated conservatively or with interventional radiology techniques, injuries treated with experimental or non-standard surgical techniques.
Prognostic factors related to secondary amputation:
a) Injury related factors: Mechanism of injury (blunt/penetrating); anatomical segment of vessel injured; associated vein/bone/soft tissue injury; associated shock.
b) Treatment related factors: ischaemic time; surgical procedure; prophylactic faciotomy; temporary shunt.
c) Complications: Infection; graft failure.
Comparator will be lower limb vascular injuries requiring surgical repair where the prognostic factor is not present.
Secondary amputation. Defined as an amputation performed after a surgical attempt at vascular repair (salvage) has occurred.
Outcome is occurrence of secondary amputation (binary), regardless of time.
Data extraction, (selection and coding)
Two independent reviewers will screen all citations for possible relevance. All identified citations from either reviewer will be assessed for inclusion eligibility. Both reviewers will then independently apply inclusion/exclusion criteria; discrepancies will be resolved by discussion and consensus.
Risk of bias (quality) assessment
Key components of study design and reporting related to the study question (population, prognostic factors, outcome, study design) will be appraised. This will include an assessment of the description of the study population, prognostic factors and outcome; definitions used; length of follow-up, standard treatment, study design, level of care and year of study.
Performance bias will be assessed by subgroup analysis (Level of care; Military vs. Civilian).
Measurement bias will be assessed based on the outcome definition.
Strategy for data synthesis
a) Descriptive summary of the included studies' key characteristics.
b) Collate and summarise the observed effects (Qualitative). Where possible, an odds ratio (95% CI) will be calculated in individual studies as a measure of the strength of the relationship between the prognostic factor and outcome. If sufficient similar studies are available, a meta-analysis of studies with available/calculated odds ratios will be performed using a random-effect model.
c) If there is a sufficient pool of data on individual patients, a multiple regression analysis will be performed to control for confounding.
d) Statistical heterogeneity will be calculated using the chi-squared test and I-squared index.
Analysis of subgroups or subsets
Military vs. Civilian outcomes.
Level 1 trauma unit (or equivalent) vs. other hospitals outcomes
Formal screening of search results against eligibility criteria
Risk of bias (quality) assessment
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.