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Cochrane Database of Systematic Reviews Protocol - Intervention

Surgical versus non surgical management of abdominal injury

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the effectiveness of surgical and non surgical interventions in the management of abdominal trauma.

Background

Description of the condition

Injury is a leading cause of morbidity and mortality worldwide. The most common causes of injury are falls from heights, road traffic accidents, and gun shot and stab wounds (Kahn 2006).

Injury to the abdomen can be blunt or penetrating. The most common cause of blunt abdominal trauma is road traffic accidents (Kahn 2006), and other causes of blunt abdominal injury include pedestrian accidents, and falls from heights (Anjum 2001). Penetrating abdominal trauma may be caused by gun shots or stab wounds from piercing instruments. Most injuries to the abdomen are blunt injuries (Kahn 2006) and are associated with higher risk of death because the extent of injury is less obvious compared with penetrating injury (Anjum 2001).

Abdominal injuries are usually associated with injury to internal organs such as the liver, spleen, kidneys, the covering of the intestine, etc. and subsequent bleeding within the abdominal cavity. Sometimes the extent of injury may not be readily obvious, particularly for blunt abdominal injuries. Severe bleeding may present with signs of haemodynamic instability: patients may have a weak pulse, low blood pressure, or be in a state of shock. Quite often these signs of internal injury may delay in manifesting clinically (Poletti 2004). Initial physical examination has been found to be unreliable to detect patients at risk of serious abdominal injury (Mackersie 1989, Hoff 2001).

Description of the intervention

The modality of management of patients with abdominal injury depends on the severity of injuries incurred and the haemodynamic state of the patient. Diagnosis of associated injuries in abdominal trauma presents a great challenge even to the best of trauma surgeons (Hoff 2001, Radwan 2006). There are reports that physical examinations, though the most important assessment for intervention, are inaccurate (Hoff 2001). Consequently, important injuries may be missed. This informs the need for active management of cases by surgical intervention. It has been observed, however, that injured organs may not be identified despite surgery (Jo 2007).

Recently, selective non‐operative approaches have been adopted to avoid unnecessary surgery for both penetrating (Demetriades 2006, Navsaria 2007) and blunt abdominal trauma (Velmahos 2003, Holmes 2005, Kahn 2006). For these interventions, patients are selected based on their haemodynamic state. Patients with signs of blood loss (haemodynamic instability) undergo surgery, while surgery is delayed for stable patients until signs of blood loss are apparent.

Why it is important to do this review

Some experts oppose non operative interventions arguing that this leads to delayed management of hollow viscous and/or mesenteric injuries (Yegiyants 2006). Other experts support non operative interventions. They argue that avoiding unnecessary surgical operation spares the patient the consequences of metabolic response to surgical trauma and possible intra‐ and post operative complications (Basile 2006).

To inform practice, there is a need for a synthesis of the available evidence on the active surgical management and non operative management (NOM) for the two types of abdominal trauma: blunt abdominal trauma (BAT) and penetrating abdominal trauma (PAT).

Objectives

To assess the effectiveness of surgical and non surgical interventions in the management of abdominal trauma.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials.

Types of participants

All patients with abdominal trauma who are haemodynamically stable.

Types of interventions

Surgical versus non surgical interventions.

Types of outcome measures

Primary outcomes

  • Mortality

Secondary outcomes

  • Need for rescue intervention (blood transfusion, surgical intervention, etc)

  • Morbidity (infection, shock, etc)

Search methods for identification of studies

Electronic searches

We will search the following electronic databases:

  • Cochrane Injuries Group's specialised register;

  • CENTRAL (The Cochrane Library (latest issue));

  • MEDLINE (1966 to date);

  • EMBASE (1980 to date);

  • Science Citation Index (1981 to date);

  • ISI Proceedings (1990 to date);

  • National Research Register (latest issue);

  • Zetoc (latest issue);

  • LILACS (1982 to date);

  • CINAHL (1982 to date).

We will base the electronic database searches on the following MEDLINE strategy which will be adapted, as appropriate, for each database:

MEDLINE (July 2008)
1.exp wounds, nonpenetrating/
2.exp wounds, penetrating/
3.exp Multiple Trauma/
4.(multiple trauma or polytrauma).ab,ti.
5.1 or 2 or 3 or 4
6.exp Thoracic Injuries/
7.exp Abdominal Injuries/
8.6 or 7
9.exp Abdomen/
10.exp Abdomen, Acute/
11.(abdominal or abdomen or stomach or gastric or diaphram* or spleen or splenic or colon or intestin* or pancreas or aortic or aorta*).ab,ti.
12.9 or 10 or 11
13.5 and 12
14.8 or 13
15.((Splenic or spleen or stomach or gastric) adj3 (rupture* or burst*)).ab,ti.
16.(abdominal adj3 compartmental adj3 syndrome).ab,ti.
17.((abdominal or abdomen or stomach or gastric or diaphram* or spleen or splenic or colon or intestin* or pancreas or aortic or aorta*) adj5 (trauma* or injur* or penetrat* or stab* or blunt* or wound*or or perforat* or stab* or gunshot or shot)).ab,ti.
18.(Hernia* adj3 Diaphragm* adj3 Trauma*).ab,ti.
19.14 or 15 or 16 or 17 or 18
20.randomi?ed.ab.
21.randomized controlled trial.pt.
22.controlled clinical trial.pt.
23.placebo.ab.
24.clinical trials as topic.sh.
25.randomly.ab.
26.trial.ti.
27.or/20‐26
28.humans.sh.
29.27 and 28
30.19 and 29

External referees will be asked to check the completeness of the search strategy and to alert the authors of any known ongoing, published and or planned trials in blunt abdominal trauma management. The searches will not be restricted by language or publication status.

Searching other resources

We will conduct an Internet search for relevant information. We will check the reference lists of all relevant articles obtained from our search and those from previously published systematic reviews to identify other possible articles.

Conference proceedings will be searched for relevant abstracts. We will also contact individual researchers who have been involved in blunt abdominal trauma studies for information on ongoing, unpublished or planned trials.

Data collection and analysis

Selection of studies

Two reviewers (UU and IAI) will apply the inclusion criteria independently to the identified studies obtained from the search. Trials that meet the inclusion criteria will be considered eligible for inclusion in the review. The authors will resolve any disagreements by discussion between the three reviewers. The Cochrane Injuries Group Co‐ordinating Editor will be consulted when the authors fail to reach an agreement.

Data extraction and management

Data extraction shall be carried out using a standard extraction form. Two authors (UU and IAI) shall extract data and AO shall crosscheck for errors and completion. Extracted data shall be entered into Review Manager by AO for analysis. Any disagreement in data extraction shall be resolved by a consensus between the three authors. Should there be missing or inadequate data, attempts will be made to obtain the data by contacting the authors.

Assessment of risk of bias in included studies

Two authors (UU and IAI) will independently assess the methodological quality of the studies that are considered eligible for inclusion. The methodological quality of included studies will include an assessment of method of random allocation of patients to care, quality of care rendered to the treatment and control groups, the extent of loss to follow‐up and outcome assessment. Each category shall be graded as 'met', 'unmet' or 'uncertain'. Quality will be rated as low risk of bias if all the four criteria are met; moderate risk of bias if one or more of the four criteria are partially met; and high risk of bias if one or more of the four criteria is not met as outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008). The Co‐ordinating Editor for the Injuries Group will be consulted when the authors fail to reach a consensus about the quality of the studies.

Assessment of heterogeneity

Heterogeneity will be quantified to be significant by using the I2 test. Heterogeneity will be considered "statistically significant" if the p value for the chi squared test is <0.1. Heterogeneity will be explored by visual inspection of the forest plot. Differences between the following subgroups will be tested: penetrating vs blunt injuries, single vs multiple injuries, adult vs child, and solid vs hollow organ lacerations.

Assessment of reporting biases

The risk of publication bias will be investigated using a funnel plot across interventions.

Data synthesis

Data from selected studies will be pooled in a meta analysis unless there is important heterogeneity that would make the pooled estimate meaningless. Binary data will be presented and combined using an Odds Ratio at 95% confidence interval.

Sensitivity analysis

Further sensitivity analysis will be carried out if there is a difference in the classification of haemodynamic state of the patients or a difference in modalities of care of patients in the different arms of the intervention.
We will perform a narrative synthesis if meta‐analysis is not possible.