Cirugía de control de daños para el traumatismo abdominal
Resumen
Antecedentes
El traumatismo es una de las principales causas de muerte en cualquier grupo etario. Se reconoce que la "tríada letal" de acidosis, hipotermia y coagulopatía es una causa significativa de muerte en pacientes con lesiones traumáticas. Para prevenir la tríada letal los dos factores fundamentales son el control temprano de la hemorragia y la prevención de la pérdida adicional de calor. En los pacientes con traumatismo abdominal grave, la cirugía de control de daños (CCD) evita procedimientos prolongados en pacientes inestables, estabiliza los problemas potencialmente mortales en la cirugía inicial y aplica la cirugía en etapas después de una reanimación inicial exitosa. Actualmente se desconoce si la CCD es mejor que la cirugía inmediata en los pacientes con traumatismo abdominal grave.
Objetivos
Evaluar los efectos de la cirugía de control de daños en comparación con el tratamiento quirúrgico inmediato y definitivo tradicional para pacientes con traumatismo abdominal grave.
Métodos de búsqueda
Se hicieron búsquedas en el Registro Especializado del Grupo Cochrane de Lesiones (Cochrane Injuries Group), CENTRAL (The Cochrane Library 2012, número 12 de 12), MEDLINE, EMBASE, Web of Science: Science Citation Index & ISI Proceedings, Current Controlled Trials MetaRegister, Clinicaltrials.gov, Zetoc, y CINAHL de todos los ensayos controlados aleatorizados publicados y no publicados. Las búsquedas no se restringieron por el idioma, la fecha o el estado de la publicación. La búsqueda se realizó hasta diciembre de 2012.
Criterios de selección
En esta revisión se incluyeron los ensayos controlados aleatorizados de cirugía de control de daños versus reparación quirúrgica tradicional inmediata. Se incluyeron pacientes con traumatismo abdominal grave (Abbreviated Injury Scale > 3) sometidos a cirugía. La selección de los pacientes fue fundamental debido a que los pacientes con lesiones abdominales relativamente simples no deben recibir procedimientos innecesarios.
Obtención y análisis de los datos
Dos autores, de forma independiente, evaluaron los resultados de la búsqueda.
Resultados principales
Se identificó un total de 2551 estudios mediante la búsqueda. No se encontraron ensayos controlados aleatorizados que compararan la CCD con la reparación inmediata y definitiva en pacientes con traumatismo abdominal grave. Se excluyeron un total de 2551 estudios porque no eran pertinentes al tema de la revisión y se excluyeron dos estudios después de examinar el texto completo.
Conclusiones de los autores
La evidencia que apoya la eficacia de la CCD con respecto a la laparotomía tradicional en pacientes con traumatismo abdominal grave es limitada.
Resumen en términos sencillos
Cirugía para pacientes con traumatismo inestable
El traumatismo es una de las principales causas de muerte en todas las edades. Algunos pacientes con traumatismo abdominal grave presentan lo que se conoce como la "tríada letal" (coagulopatía, acidosis metabólica e hipotermia). Esta es una enfermedad potencialmente mortal que contribuye significativamente con la morbimortalidad. Para prevenir esta tríada letal, los médicos deben controlar la hemorragia y prevenir la pérdida adicional de calor.
El tratamiento tradicional del traumatismo abdominal grave incluye la cirugía para reparar los órganos desgarrados o el tejido abdominal. En los pacientes con traumatismos, la cirugía inmediata puede ser riesgosa ya que el estado del paciente puede ser inestable debido a la pérdida de sangre.
La cirugía de control de daños (CCD) es un método alternativo. Incluye tres pasos para ayudar al paciente. Primero, un cirujano repara los desgarros graves y se atiende al paciente en la unidad de cuidados intensivos. Una vez que el paciente se encuentra estable, los cirujanos realizan una cirugía para reparar cualquiera de los restantes desgarros más pequeños. La ventaja del método de CCD es que los cirujanos sólo realizan la cirugía más minuciosa y, por lo tanto, más prolongada una vez que el paciente está estable y esto disminuye las probabilidades de un resultado adverso, como la muerte por pérdida masiva de sangre.
Los autores no encontraron ensayos controlados aleatorizados publicados ni pendientes que compararan la CCD con la reparación inmediata y definitiva en pacientes con traumatismo abdominal grave. Por lo tanto, la evidencia que apoya la eficacia de la CCD en comparación con la laparotomía tradicional es limitada.
Authors' conclusions
Background
Trauma is one of the leading causes of death in every age group, it is the leading cause of death for people aged one to 44 years (Feliciano 2007). Abdominal trauma is subdivided into two groups based on the mechanism of injury, which may be penetration or blunt trauma. Motor vehicle crashes account for about 75% of blunt abdominal trauma cases, while gunshot and stab wounds are the main mechanisms of injury in cases of penetrating trauma. For blunt abdominal trauma, non‐operative management has become the standard treatment in most trauma centres.
In major abdominal trauma patients, impaired coagulation, metabolic acidosis from low tissue perfusion, haemodynamic instability, infections, and pulmonary complications significantly contribute to morbidity and mortality (Moore 1998). During initial operative and resuscitation efforts, the presence of acidosis, hypothermia, and coagulopathy is associated with high mortality in patients with traumatic injuries (Mikhail 1999; Moore 1996). Consequently, suitable interventions are needed to control bleeding and prevent further heat loss (Zacharias 1999).
In the early 1980s, Harlan Stone described the first damage control procedure performed on a patient 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 procedure for patients with major abdominal trauma (Rotondo 1993). DCS avoids extensive procedures on unstable patients and may stabilize potentially fatal problems at initial operation. Extensive procedures are later applied in staged surgery after the successful initial resuscitation (Lee 2006). The DCS strategy is fundamentally based on 'damage control laparotomy', which is also called 'abbreviated laparotomy'. This phase is essentially aimed at obtaining surgical control of haemorrhage and contamination as quickly as possible. It is then followed by temporary abdominal closure (Burch 1992). The main methods for achieving control of haemorrhage are ligation, suturing, or temporal shunting of vascular injuries; packing of liver injuries; and splenectomy (in the presence of splenic injury) (Sharp 1992). Due to bowel oedema, trauma patients' abdominal walls may not feasibly be closed because of the risk of 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 in order to prevent abdominal compartment syndrome. These are 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 to 36 hours of phase one, the abdominal packs are removed, definitive repairs take place, there is a second look laparotomy for missed injuries, and then the abdomen is closed (Germanos 2007).
Description of the condition
In major trauma patients, impaired coagulation, metabolic acidosis, haemodynamic instability, infections, and pulmonary complications significantly contribute to morbidity and mortality (Moore 1998). During initial operative and resuscitation efforts the presence of acidosis, hypothermia, and coagulopathy is associated with high mortality (Mikhail 1999).
Description of the intervention
Damage control surgery is characterized by a staged approach to patients with major abdominal trauma. The approach considers, when necessary, the immediate arrest (with packing or vascular clamps and suture ligatures) of severe bleeding from parenchymal injuries (liver, spleen, pancreas, and kidney), major vessels injuries, retroperitoneal injuries, and the stapling of the intestines for the temporary control of peritoneal contamination from hollow visceral injuries (stomach, small bowel, colon‐rectum, and bladder). Initial resuscitation, if necessary, is followed by a brief initial laparotomy, intensive care unit management, and a final planned re‐operation. In the final stages of surgery, the abdomen is left open to avoid abdominal compartment syndrome.
The rationale for damage control surgery is that mortality in surgical patients who develop hypothermia, acidosis, and coagulopathy (the 'lethal triad') is extremely high unless patients' physiologic stability is re‐established. The control intervention in this review is immediate, traditional surgical treatment for the injuries.
How the intervention might work
The advantage of damage control surgery 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 (for example bleeding from liver trauma, retroperitoneal injuries, or peritoneal contamination from traumatic bowel perforation) presents the advantages of not requiring re‐operation 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
The effects of the damage control surgery approach compared to traditional immediate surgical repair is an unanswered clinical question.
Objectives
To assess the effects of damage control surgery compared to traditional immediate definitive surgical treatment for patients with major abdominal trauma.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs).
Types of participants
Patients with major abdominal trauma (Abbreviated Injury Scale > 3 (Champion 1989)) undergoing surgery. Patient selection is crucial as patients with relatively simple abdominal injuries should not undergo unnecessary procedures. Haemodynamic instability, manifested by hypotension, tachycardia and tachypnoea, coagulopathy, or hypothermia, is an important indication for the damage control approach. The control intervention is immediate, traditional surgical repair of the injuries.
Types of interventions
Damage control surgery for major abdominal trauma (Abbreviated Injury Scale > 3) versus immediate, traditional surgical repair in the management of major abdominal trauma.
Types of outcome measures
Primary outcomes
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Overall short‐term mortality (within 30 days of surgery)
Secondary outcomes
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Overall short‐term morbidity (within 30 days of surgery)
Search methods for identification of studies
Searches were not restricted by language, date, or publication status.
Electronic searches
We searched the following electronic databases:
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Cochrane Injuries Group Specialised Register (19 December 2012);
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CENTRAL (The Cochrane Library 2012, Issue 12 of 12);
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MEDLINE (OvidSP) (1946 to December (week 1) 2012);
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EMBASE (OvidSP) (1980 to December 2012 (week 51);
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ISI Web of Science: Conference Proceedings Citation Index‐Science (1990 to Dec 2012);
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ISI Web of Science: Science Citation Index Expanded (SCI‐EXPANDED) (1970 to Dec 2012);
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CINAHL (1982 to 19 December 2012);
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Zetoc (19 December 2012);
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Current Controlled Trials metaRegister (29 December 2012);
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Clinicaltrials.gov (searched 29 December 2012).
Details of the search strategies can be found in Appendix 1.
Searching other resources
We searched abstracts presented at the following international scientific society conferences:
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American Association for the Surgery of Trauma (1999 to December 2012);
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American College of Surgeons (2000 to December 2012);
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Eastern Association for the Surgery of Trauma (2005 to December 2012);
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Società Italiana di Chirurgia (1985 to December 2012).
We checked the reference lists of all relevant studies retrieved from our search and from relevant, published systematic reviews in order to identify other possible studies for inclusion. We conducted an Internet search for grey literature and other information related to our topic.
Data collection and analysis
We conducted the review according to the recommendations of The Cochrane Collaboration (Higgins 2008) and the Cochrane Injuries Group. We used Review Manager (RevMan) software to conduct the review.
Selection of studies
Two authors (RC, IA) assessed titles or abstracts of all studies identified by the initial search and excluded clearly irrelevant studies. We obtained the full text of potentially relevant studies, including any studies with unclear methodologies. Two authors independently assessed the full‐text articles to determine whether they met the inclusion criteria for this review and to evaluate the method of randomisation and adequacy of allocation concealment. We resolved disagreements about study inclusion by discussion and, if necessary, with the assistance of an independent third author (AM).
Data extraction and management
In the future, if studies are included in the review, 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
In the future if studies are included in the review, 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. IA and RC will clarify any unclear or missing information by contacting the authors of the specific trials. We will resolve differences in opinion between the authors extracting data through discussion. AM will serve as arbitrator when differences in opinion persist.
Assessment of methodological quality of studies
In the future if studies are included in the review, 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 by the Cochrane Injuries Group. Due to the risk of biased overestimation of intervention effects in randomised trials with inadequate methodological quality (Schulz 1995; Wood 2008), 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 the randomisation sequence, allocation concealment, blinding, and follow up.
Sequence generation
Adequate: if a computer‐generated or random number table was used.
Unclear: if the trial was described as randomised, but the report 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.
Allocation concealment
Adequate: if centralised or pre‐numbered containers are administered serially to patients, 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.
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
In the future if studies are included in the review, we will analyse dichotomous data with risk ratio (RR) or odds ratio (OR). Absolute effects will be measured with risk differences. We will calculate 95% confidence intervals (CI) for these measures of effect. We will perform intention‐to‐treat analysis by 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.
Dealing with missing data
If studies are included in the review in the future, we will contact trial investigators if additional information is required.
Assessment of heterogeneity
If studies are included in the review in the future, we will use the Chi2 test and I2 statistic to assess heterogeneity. An I2 value of > 50% will be used as an indicator of statistical heterogeneity. If outcomes were measured with continuous scales, we will analyse data of treatment effects using the mean difference. Where different trials used different scales, we will standardise and combine the results (using the standardised mean difference).
Assessment of reporting biases
In the future if there are 10 or more studies included in the review, we will use a funnel plot to explore publication 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).
Sensitivity analysis
In the future if trials are included in the review, IA and RC will independently perform a sensitivity analysis by examining the trial inclusion criteria, re‐assessing excluded studies, re‐analysing data imputing, and re‐analysing data using the DerSimonian and Laird method (DerSimonian 1986).
Results
Description of studies
Results of the search
A total of 2551 studies were identified by the search. The study selection process is summarized in the PRISMA flow diagram (Moher 2009; see Figure 1)
Study selection according to PRISMA (Moher 2009) flow diagram (searches from first publication to Dec 2012).
Included studies
No randomised controlled studies comparing DCS with immediate and definitive repair in patients with major abdominal trauma were found.
Excluded studies
A total of 2551 studies were excluded because they were not relevant to the topic of the review, two studies were excluded because they were case‐controlled studies (Rotondo 1993; Stone 1983).
Risk of bias in included studies
No studies were included in this review.
Effects of interventions
No studies were included in this review.
Discussion
We found no published or pending randomised controlled trials that compared DCS with immediate and definitive repair in patients with major abdominal trauma for inclusion in this review.
Most of the current information relating to DCS comes from case studies (Colombo 2005; Kudera 2004) and observational studies (Bach 2008; Cotton 2008; Feliciano 1988; Hirshberg 1994; Rotondo 1993; Saifi 1990; Sharp 1992).
In light of the paucity of studies, evidence that supports efficacy of DCS compared to immediate, traditional laparotomy is limited. Good quality randomised controlled trials comparing DCS and traditional, immediate repair are warranted. A carefully designed RCT of this intervention is possible, and the results of such a trial will help to improve the critical decision making of multidisciplinary teams in the future.
Study selection according to PRISMA (Moher 2009) flow diagram (searches from first publication to Dec 2012).
