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Cochrane Database of Systematic Reviews Protocol - Intervention

Damage control surgery for abdominal trauma

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Abstract

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

To assess the effectiveness of DCS compared to traditional immediate definitive surgical treatment for severely injured patients.

Background

In the United States, trauma represents the fourth cause of death for all ages, and is the leading cause of death for people age one to 44 (Fingerhut 2003). Abdominal trauma is subdivided into two groups, based on the mechanism of injury: penetrating or blunt trauma. Motor vehicle crashes account for 75% of blunt abdominal injuries. Penetrating abdominal trauma is usually caused by a gunshot wound (GSW) or stab wound. In blunt abdominal trauma, non‐operative management has become the standard of care in most trauma centers.

By the time of laparotomy most liver injuries (up to 80%) have stopped bleeding (Meredith 1992). In 50% of patients with severe abdominal trauma, there are thoracic injuries (Arvieux 2003). In patients with major abdominal trauma, the increased morbidity and mortality is due to impaired coagulation, metabolic acidosis from low tissue perfusion, haemodynamic instability, infections and pulmonary complications (Moore 1998). The 'lethal triad' of acidosis, hypothermia, and coagulopathy during initial operative and resuscitation efforts has been recognized as a significant cause of death in patients with traumatic injuries (Mikhail 1999). Early control of bleeding and prevention of further heat loss are key factors in avoiding the 'lethal triad' (Zacharias 1999).

In the early 1980s, Harlan Stone described the first damage control operation to manage patients who developed coagulopathy during a laparotomy performed for trauma (Stone 1983). The term ‘damage control surgery’ (DCS) was first described for trauma treatment by Rotondo and Schwab, who in 1993 outlined a three‐phase approach to patients with major abdominal trauma (Rotondo 1993). DCS avoids extensive procedures on unstable patients, stabilizes potentially fatal problems at initial operation, and applies staged surgery after successful initial resuscitation: a brief initial laparotomy, subsequent intensive care unit resuscitation, and a planned reoperation (Lee 2006). The DCS strategy is the 'damage control' laparotomy; the aim of this phase is to facilitate surgical control of haemorrhage and contamination (“abbreviated laparotomy”) as quickly as possible. It is followed by temporary abdominal closure (Burch 1992). Stopping haemorrhage can be by ligation, suturing, or temporal shunting of vascular injuries, packing of liver injuries, and splenectomy in the presence of splenic injury (Sharp 1992). The abdomen of a patient may be edematous and unable to be closed without developing intra‐abdominal hypertension (IAH) (Raeburn 2001). The simplest option for abdominal closure (direct suture of the abdominal wall) is not the preferred technique as it results in tissue tension and IAH. Several techniques have been suggested for abdominal closure to avoid abdominal compartment syndrome (ACS): towel clip closure of the skin, temporary silos, vacuum‐assisted wound closure, open packing, and absorbable or permanent meshes (Letoublon 2005). In phase three, which usually takes place within 24‐36 hours of phase one, the patient undergoes the removal of abdominal packs, definitive repair, second look laparotomy for missed injuries, and abdominal closure (Germanos 2007).

Description of the intervention

DCS is a potentially life‐saving procedure for a few selected critically injured patients. In DCS, there is an immediate arrest (with packing or vascular clamps and suture ligatures) of severe bleeding from parenchimal injuries (liver, spleen, pancreas, and kidney), major vessels injuries, retro‐peritoneal injuries, and a stapling of intestine for the temporary control of peritoneal contamination from hollow visceral injuries (stomach, small bowel, colon‐rectum, and bladder). In the final stages of surgery, the abdomen is left open to avoid ACS. The rationale for DCS is that mortality in surgical patients who develop hypothermia, acidosis, and coagulopathy (the 'lethal triad') is extremely high unless patients' physiologic stability is reestablished. The control intervention in this review is immediate traditional surgical treatment for the injuries.

How the intervention might work

The advantage of DCS is the immediate control of severe haemorrhage and the rapid correction of hypothermia, acidosis, and coagulopathy. The disadvantages include the need for further surgical repair, with the possibility of high morbidity. The immediate and definitive repair of the injuries (e.g. bleeding from liver trauma or retroperitoneal injuries or peritoneal contamination from traumatic bowel perforation) presents the advantages of not requiring reoperation for definitive surgical treatment. The disadvantage is a long operative time for a complex repair of injuries.

Why it is important to do this review

This review is important to explore if DCS reduces the incidence of mortality and morbidity with respect to immediate and definitive repair in patients with major abdominal trauma.

Objectives

To assess the effectiveness of DCS compared to traditional immediate definitive surgical treatment for severely injured patients.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs) evaluating DCS versus immediate traditional surgical repair in the management of severe abdominal trauma.

Types of participants

Patients with major abdominal trauma undergoing surgery (Abbreviated Injury Scale > 3). Patient selection is crucial, as patients with relatively simple abdominal injuries should not undergo unnecessary procedures. Hemodynamic instability, manifested by hypotension, tachycardia and tachypnea, coagulopathy, and/or hypothermia are important indications for the damage control approach. The control intervention is immediate traditional surgical repair of the injuries.

Types of interventions

Interventions and specific comparisons to be made in severe abdominal trauma: all patients who underwent DCS will be compared with patients who underwent traditional immediate definitive surgical treatment.

Types of outcome measures

Primary outcomes

  • Overall short‐term mortality rates (within 30 days of surgery).

Secondary outcomes

  • Overall short‐term morbidity (within 30 days of surgery).

Search methods for identification of studies

We will search for all published and unpublished RCTs. We will ask authors of relevant papers to provide further information using a data extraction form. We will not restrict searches by language, date, or publication status.

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);

  • Current Controlled Trials metaRegister (latest issue);

  • Zetoc (latest issue);

  • CINAHL (1982 to date).

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

MEDLINE (Ovid interface; 1950‐2008)
1. exp Abdominal Injuries/
2. exp Thoracic Injuries/
3. ((abdominal or abdomen) adj3 (injur$ or trauma$ or perforat$ or penetrat$)).ab,ti.
4. exp Multiple Trauma/
5. (multiple trauma or polytrauma).ab,ti.
6. exp Hemoperitoneum/
7. h?emoperitoneum.ab,ti.
8. exp Retroperitoneal Space/
9. retroperitoneum.ab,ti.
10. (abdominal adj3 compartmental adj3 syndrome).ab,ti.
11. (Hernia* adj3 Diaphragm* adj3 Trauma*).ab,ti.
12. ((splenic or spleen) adj3 rupture*).ab,ti.
13. ((stomach or gastric) adj3 (rupture or perforation or injur$ or burst$)).ab,ti.
14. exp Wounds, Stab/
15. exp Wounds, Gunshot/
16. exp Rupture/
17. ((stab$ or gunshot or shot or penetrat$ wound$) adj3 (abdomen$ or abdominal or stomach or splenic or spleen)).ab,ti.
18. ((spleen or splenic) adj3 (wound* or injur* or trauma* or perforat* or penetrate*)).ab,ti.
19. ((liver or hepatic) adj3 (wound* or injur* or trauma* or perforat* or penetrate*)).ab,ti.
20. or/1‐19
21. exp Surgery/
22. exp Laparotomy/
23. (laparotomy or re‐laparotomy).ab,ti.
24. surgery.fs.
25. "minilaparotom*".ab,ti.
26. (laparotom* or re‐laparotom*).ab,ti.
27. or/21‐26
28. 20 and 27
29. (randomised or randomized or randomly or random order or random sequence or random allocation or randomly allocated or at random or controlled clinical trial$).tw,hw.
30. clinical trial.pt.
31. randomized controlled trial.pt.
32. 29 or 30 or 31

Searching other resources

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

We will handsearch abstracts presented at the following international scientific societies:

  • American Association for the Surgery of Trauma (1999 to date);

  • American College of Surgeons (2000 to date);

  • Eastern Association for the Surgery of Trauma (2005 to date);

  • Società Italiana di Chirurgia (1985 to date).

We will also contact individual researchers in the field for information on ongoing, unpublished, or planned trials.

Data collection and analysis

We will conduct the review according to the recommendations of The Cochrane Collaboration (Higgins 2008) and the Cochrane Injuries Group. We will use Review Manager (RevMan) software to conduct the review.

Selection of studies

Two authors (RC, IA) will assess titles or abstracts of all studies identified by the initial search and will exclude clearly non‐relevant studies. We will obtain the full text of articles for potentially relevant studies and any studies with unclear methodology. Two authors will independently assess these studies to determine whether they meet the inclusion criteria for this review, and to evaluate the method of randomisation and adequacy of allocation concealment. We will resolve disagreements on inclusion by discussion and, if necessary, by scrutiny by an independent third author (AM).

Data extraction and management

Two investigators (IA, RC) will independently extract the following information for each included trial: method of outcome; blinding of outcome evaluators; and balance of prognostic factors.

Assessment of risk of bias in included studies

Methodological quality

IA and RC will record whether the authors of the studies used a sample size calculation, and whether or not they performed the analysis using an intention‐to‐treat method. IA and RC will assess the methodological quality of each trial independently. We will clarify any unclear or missing information by contacting the authors of the specific trial. We will resolve differences in opinion between the authors extracting data through discussion. AM will serve as arbitrator in case differences in opinion persist.

Assessment of methodological quality of studies

IA and RC will assess the methodological quality of the trials independently, without masking of the trial names. The review authors will follow the instructions given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008) and the Cochrane Injuries Group. Due to the risk of biased overestimation of intervention effects in randomised trials with inadequate methodological quality (Kjaergard 2001; Schulz 1995), IA and RC will consider the methodological quality of the trials by evaluating the reported randomisation and follow‐up procedures in each trial. If information is not available in the published trial, IA and RC will contact the authors for this information. IA and RC will assess generation of allocation sequence, allocation concealment, blinding, and follow‐up.

Allocation concealment

Adequate: if centralised, or pre‐numbered containers administered serially to patients, or an on‐site computer with allocations in a locked unreadable file, or sequentially numbered sealed opaque envelopes.

Unclear: if the trial is described as randomised, but failed to describe the method of allocation concealment.

Inadequate: if a completely transparent procedure was used. For example, if case record numbers, dates of birth, or an open list of random numbers was used.

Allocation sequence generation

Adequate: if a computer‐generated or random number table was used.

Unclear: if the trial is described as randomised, but failed to describe the method of allocation sequence.

Inadequate: if patients were allocated according to names, dates, admittance numbers, etc. These are known as quasi‐randomised trials and we will exclude them from the review.

Follow up

Adequate: if the numbers and reasons for dropouts and withdrawals in all intervention groups were described or if it was specified that there were no dropouts or withdrawals.

Unclear: if the report gave the impression that there had been no dropouts or withdrawals, but this was not specifically stated.

Inadequate: if the number or reasons for dropouts and withdrawals were not described.

IA and RC will record sample size and duration of follow up.

Measures of treatment effect

We will analyse dichotomous data for relative risk ratio (RR), odds ratio (OR), and the absolute effects will be measured with the risk differences. We will calculate 95% confidence intervals for these measures of effect. We will perform intention‐to‐treat analysis extracting the number of patients originally allocated to each treatment group irrespective of compliance. If numbers extracted by the two authors are different, a third author (FS) will resolve differences. We will use the Mantel‐Haenszel method for the meta‐analysis (Greenland 1985; Mantel 1959). We will present results on a forest plot graph.

Dealing with missing data

We will contact trial investigators if additional information is required.

Assessment of heterogeneity

We will use the Chi2 test for heterogeneity assessment. If outcomes were measured with continuous scales, we will analyse data of treatment effects with mean difference. Where different trials use different scales, we will standardise and combine the results (i.e. standardised mean difference).

Assessment of reporting biases

We will use a funnel plot to explore bias (Egger 1997; Macaskill 2001). We will perform linear regression using the approach described by Egger et al to determine the funnel plot asymmetry (Egger 1997).

Subgroup analysis and investigation of heterogeneity

We will perform two subgroup analyses:

  • the valuation of the feasibility of the techniques suggested for abdominal closure to avoid the ACS in patients who underwent DCS; and

  • the valuation of the primary and secondary outcomes in patients with abdominal major trauma associated with thoracic or neck major trauma.

Sensitivity analysis

IA and RC will independently perform a sensitivity analysis by examining the trial inclusion criteria, reassessing excluded studies, re‐analysing data imputing, and re‐analysing data using the DerSimonian and Laird method (DerSimonian 1986).