Follow-up strategies for patients with splenic trauma managed non-operatively: the 2022 World Society of Emergency Surgery consensus document

This consensus document has been created by a WSES (World Society of Emergency Surgery) collaborative group to identify clinically relevant questions and encourage the members of the experts' panel to finally achieve a Consensus on the main topics of interest regarding the follow-up of patients with splenic trauma treated with NOM.

A modified Delphi method was implemented to reach the Consensus. The chairs of the Consensus (FC, MP) selected panel members based on contributions to the peer-reviewed literature on abdominal trauma. Forty-eight experts were identified based on this method, and a personal email invitation to participate in the Consensus was sent to them.

Topics elaboration and prioritization

The subject of follow-up of splenic trauma patients treated with NOM was divided into 11 main research questions. Research topics and questions were formulated, revised, and approved by all experts in two subsequent Delphi rounds in February 2022–March 2022. Each panel member was sent a questionnaire with instructions to comment on each topic based on their personal opinion, experience, or previous research.

After each Delphi round, the panel was presented with an aggregated summary of the previous round, allowing each expert to adjust their answers according to the group response. In the first Delphi round, the panel members were encouraged to suggest up to ten relevant research questions related to the follow-up of patients with splenic trauma treated with NOM. The first Delphi round was closed on Sunday March 6, 2022. Forty-two members of the experts' panel took part in the first round, and 312 open answers were returned to the facilitator, who grouped the comments and prepared copies of the information. A copy of the compiled comments was sent to each participant, along with the opportunity to comment further. The second round of the Delphi process involved the prioritization of the clinically relevant research questions that were suggested during the first round. The panel was called to rate on a Likert scale from 1 to 5 (1 = No relevant; 2 = Of little relevance; 3 = Moderately relevant; 4 = Very much relevant; 5 = Extremely relevant) the research questions to be explored in the literature review. The second Delphi round was closed on Sunday, March 20, 2022. The Consensus was defined as > 70% of scores ranging from 4 to 5. The selected research questions were finally stratified according to the level of relevance achieved in the second Delphi round, in "urgent priority," "high priority," or "medium priority" questions. The steering committee appointed an evidence review team (ERT) composed of six experts in the literature search, appraisal, and the creation of guidelines. The ERT conducted the literature search and drafted statements and recommendations on each research question (Fig. 1).

Fig. 1figure 1

Summary of the modified Delphi process

Literature review

The literature review process was carried out conforming to the 2020 update of the PRISMA statement standards for systematic reviews and meta-analyses [13] between February 26, 2022, and April 22, 2022. MEDLINE (via PubMed), Google Scholar, the Cochrane Central Register of Controlled Trials, and EMBASE were systematically searched for relevant studies. Citations were included for the period between January 2000 and March 2022.

Studies were identified in PubMed using the MeSH terms "Splenic trauma" OR "Splenic injury" AND "Follow-up." Similar search strategies were performed in Embase and Google Scholar. The Cochrane database was searched for all articles relating to splenic trauma. After performing different searches, duplicates were identified and deleted. To increase the yield of the systematic search, the reference list of relevant articles and guidelines for treating patients with splenic trauma were searched.

Study inclusion criteria included systematic reviews with or without meta-analyses, randomized controlled trials, nonrandomized cohort studies (including registry studies), and case series on the follow-up of patients with splenic injuries treated with NOM, published in the English language between January 2000 and March 2022. Animal studies, case reports, narrative reviews, commentaries, and studies on splenic injuries not including specific information on the type of NOM were excluded. All relevant information was reported and discussed to answer the research questions.

The GRADE methodology

The recommendations were formulated and graded according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence [14], summarized in Table 1. The quality of evidence (QoE) was marked as high, moderate, low, or very low. This could be either downgraded in case of significant bias or upgraded when multiple high-quality studies showed consistent results. The highest quality of evidence studies (systematic reviews with meta-analysis of randomized controlled trials) was assessed first. If the meta-analyses were of sufficient quality, they were used to answer the research question. If no meta-analysis of sufficient quality was found, randomized controlled trials and nonrandomized cohort studies were evaluated. The strength of the recommendation (SoR) was based on the level of evidence and qualified as weak (defined as a suggestion or conditional recommendation) or strong (recommendation) [15, 16]. The panel group reviewed the content and strength of each statement and recommendation following the informative documents provided by the ERT during the third and last Delphi round.

Table 1 GRADE Quality of evidence and strength of recommendationsAgreement on statements and recommendations

The Delphi methodology was implemented to reach an agreement among the experts on all statements and recommendations. Each was subject to voting by the experts' panel using the Google Forms online platform. When a unanimous consensus was not reached, supporting evidence from the systematic review of the literature performed for the specific research question was presented and discussed, and, if necessary, the second round of voting was carried out. Each recommendation was then voted upon by the panel, and consensus was considered to have been reached if at least 80% of votes were in favor of the statement. Where there was discordance, the recommendation was improved with panel input until approval was granted (Table 2).

Table 2 Summary of the 2022 WSES consensus on the follow-up strategies for patients with splenic trauma treated with non-operative management (NOM). Statements and recommendationsNotes on the use of this consensus paper

This consensus paper presents the diagnostic and therapeutic methods for optimal follow-up strategies for patients with blunt splenic trauma treated with NOM. The practice suggestions promulgated in this manuscript do not represent a standard of practice. These are suggested plans of care based on the best available scientific evidence and experts' consensus, but they do not exclude other approaches as being within the standard of practice. They should not be used to compel adherence to a given medical management method, which method should be finally determined after considering the conditions at the relevant medical institution (staff levels, experience, surgical skills, equipment, etc.) and the characteristics of the individual patient. The treatment results' responsibility rests with those directly engaged and not with the consensus group.

Research Question 1: What is the optimal duration of bed rest for patients treated with NOM for splenic trauma according to the injury grade? (High priority).

Statement. Abbreviated bed rest of 24 h is safe and does not increase NOM failure. The panel agrees that early mobilization could be considered in all splenic injury patients according to their general condition and associated injuries [Quality of Evidence: Moderate]. The day on which mobilization was performed is not associated with an increased risk of delayed hemorrhage in adult patients with low (WSES Class I, AAST Grades I–II) and high-grade (WSES Classes II–III, AAST Grades III–V) splenic injuries [Quality of Evidence: Moderate]. Current evidence supports an abbreviated period of bed rest of 24 h or less after splenic injury for hemodynamically stable children whose hemoglobin has been documented to be stable [Quality of Evidence: Moderate].

Recommendation. The panel suggests allowing early mobilization within 24 h in patients with low-grade (WSES Class I, AAST Grades I–II) splenic injuries treated with NOM. Patients with WSES Class II (AAST Grade III) splenic injuries can be mobilized after 2 days from the trauma if no other contraindications exist [Strength of Recommendation: Conditional recommendation, based on Low quality of evidence, Agreement 89.1%]. In patients with high-grade splenic injuries (WSES Class III, AAST Grades IV–V), if no other contraindications to early mobilization exist, the patient can be mobilized safely after 2 days from the trauma when three successive hemoglobins 8 h apart after the first are within 10% of each other, and if clinical parameters remain stable [Strength of Recommendation: Conditional recommendation, based on Low quality of evidence, Agreement 87.2%]. The panel suggests a shortened protocol of one night of bed rest for WSES Class I injuries (AAST Grade II; no need for bed rest for AAST Grade I) and two nights for WSES Classes II–III (AAST Grade ≥ III) in children when clinical parameters remain stable [Strength of Recommendation: Conditional recommendation, based on Moderate quality of evidence, Agreement 82.6%].

In patients with blunt solid organ injuries, the panel suggests to weigh the risk of delayed hemorrhage against the risk of prolonged bed rest, which includes deep vein thrombosis (DVT), venous thromboembolism (VTE), pulmonary embolism (PE), pneumonia, hospital infections, and is associated with increased length of hospitalization and costs. Historically, NOM for solid organ injuries included bed rest to prevent delayed hemorrhage because movement or an unintended patient fall could disrupt the clot overlying a splenic or liver injury and lead to a delayed organ rupture, even up to many days after the initial trauma. However, during the last 10 years, this supposition has been contested in pediatric trauma patients [17], and protocols incorporating periods of strict bed rest have proven unnecessary. Several studies demonstrated that a shortened bed rest of 24 h is safe, does not increase failure of NOM, and that the day on which mobilization was commenced is not associated with an increased risk of delayed hemorrhage both in low (Grades I–II) and high (Grades III–V) grade splenic injuries [17, 18]. Failure of NOM is principally due to the evolution of PSA or artero-venous fistula, and early mobilization does not affect bleeding from these vascular injuries.

Our systematic review of the literature regarding this topic retrieved seven studies, of which four were conducted in the pediatric population [19,20,21,22], and three in the adult population [17, 23, 24]. Two were prospective cohort studies [19, 20], five were retrospectives [5, 17, 21, 23, 24], and one was a systematic review of the literature [22].

Based on the current evidence, the timing of mobilization of patients with blunt solid organ injuries does not seem to contribute to delayed hemorrhage requiring laparotomy. Therefore, protocols incorporating prolonged periods of strict bed rest are unnecessary. In the retrospective study by London et al. [24], of 454 patients with blunt solid organ injuries admitted to the hospital for NOM, 4.0%, 1.0%, and 7.1% for renal, hepatic, and splenic injuries, respectively, failed conservative treatment. Ten patients (5.5%) with splenic injuries failed secondary to delayed hemorrhage. Eighty-four percent of patients with renal injuries, 80% with hepatic injuries, and 77% with splenic injuries were mobilized within 72 h of admission. Day of mobilization was not associated with delayed splenic rupture in multivariate analysis (OR, 0.97; 95% CI 0.90–1.05). According to the authors, the timing of mobilization of patients with blunt solid organ injuries does not seem to contribute to delayed hemorrhage requiring laparotomy, as demonstrated by the fact that day of mobilization was not associated with delayed splenic rupture in multivariate analysis. Griffard et al. [23] evaluated the safety, in terms of risk of delayed hemorrhage and subsequent failure of NOM, and complications of early ambulation within 24 h in low-grade splenic trauma to assess the length of stay, development of pneumonia, pleural effusions, VTE, and PE. In this study, of the 163 total patients, 100 (61.3%) were on bed rest for at least 24 h after their injury, and 63 (38.7%) were ambulated within the first 24 h. In the group of patients allowed to ambulate during the first 24 h, there were no failures of NOM, whereas, in those for those who bed rest for at least 1 day was prescribed, 6 (6%) failed NOM. There were no statistically significant differences in DVT, PE, pleural effusions, pneumonia, and length of hospitalization.

Other studies evaluated the timing of mobilization of patients with blunt solid organ injuries concerning the rates of delayed rupture. They found that the timing of mobilization in these patients was not associated with an increased incidence of delayed rupture and hemorrhage. Teichman et al. [17] showed that a specific NOM protocol, including early mobilization in blunt splenic and hepatic injuries, is safe and more cost-effective than extended bed rest protocols. In their study, patients managed non-operatively from January 2008 through July 2011 were observed in the hospital under a prolonged bed rest protocol of 3 days prior to ambulation. In August 2011, an early mobilization protocol was adopted. Patients with low-grade splenic and/or hepatic injuries were observed with bed rest overnight until two successive hemoglobins 12 h apart were within 10% of each other. The patient was then ambulated and eligible for discharge if hemoglobin the morning following ambulation was within 10% of the previous values. Patients with high-grade injuries were admitted to the ICU and kept on bed rest until three successive hemoglobins 8 h apart after the first hemoglobin check were within 10% of each other. These patients were then ambulated and eligible for discharge if hemoglobin the following day was within 10% of the previous values. The authors found that the length of hospital stay was significantly reduced in the early mobilization group, with an average stay of 4.53 days in the prolonged bed rest group and 3.46 days in the early mobilization group. The two groups did not differ in NOM failure, angiography, embolization, or mortality. Through the implementation of an early mobilization protocol, the length of hospital stay was shortened by 1.07 days, and the cost of hospitalization was reduced by $7077, without any difference in NOM failure, angiography/embolization, or mortality.

In the pediatric population, the Trauma Committee of the American Pediatric Surgical Association (APSA) recommends a period of bed rest to equal the grade of injury plus 1 day [25]. However, the description of a shortened bed rest protocol for children was reported in 2008 by St Peter et al. [26]. They stated that a trauma protocol with overnight bed rest for AAST Grades I and II injuries and two nights for higher grades could be safely used. This shortened protocol was then validated in 2011 [19] in a prospective study that enrolled a total of 131 patients with blunt splenic or liver injuries and confirmed that a protocol of one night of bed rest for AAST Grade I and II injuries and two nights for Grade III or higher could be safely used, resulting in dramatic decreases in hospitalization compared with the APSA recommendations. Another study by St Peter et al. [20] further validated that an abbreviated protocol of one night of bed rest for AAST Grade I and II injuries and two nights for Grade ≥ III can be safely employed in children. In this validation study, injuries included isolated spleen in 130 (52%), liver only in 107 (43%), and both in 12 (5%). If the patient received a transfusion, the time frame was reset, and the clock for bed rest restarted. This study demonstrated that bed rest was the limiting factor keeping nearly two-thirds of their patients with splenic injuries in the hospital. If the authors had followed the APSA guidelines, these patients would have averaged an extra day of hospitalization. Dodgion et al. [21] confirmed that a shortened bed rest protocol consisting of 1-day bed rest for AAST Grade I–II splenic injuries and 2-days bed rest for Grade III or higher could safely reduce the duration of hospital stay without any increase in NOM failure and short-term complication rates. In a large cohort of 22,153 patients with blunt splenic or liver injuries, they found that application of an abbreviated bed rest protocol could potentially save 1.7 hospital days/patient or 36,964 patient hospital days nationally compared to the standard APSA protocol. According to the WSES guidelines [1], in hemodynamically stable children without a drop in hemoglobin levels, bed rest could be suggested for 24 h. Currently, there is no evidence to support bed rest as a treatment for blunt liver or splenic injuries, and no evidence suggests that bed rest prevents re-bleeding in children. Several prospective studies showed that a shortened period of bed rest is safe, even though prolonged bed rest protocols and admissions are still commonplace [22, 24].

Research Question 2: What is the optimal timing and type of anti-thrombotic prophylaxis for patients with splenic trauma treated with NOM? (High priority).

Statements. In the absence of contraindications related to associated injuries or conditions, such as intracranial hemorrhage, hemorrhagic diathesis, or patients under anticoagulation therapy, the best available evidence supports that deep vein thrombosis (DVT) and venous thromboembolism (VTE) prophylaxis can safely be initiated within 48–72 h of admission for blunt splenic trauma, regardless of injury grade, without concern for exacerbation of bleeding, or failure of NOM [Quality of Evidence: Moderate]. Occurrence rates of thrombocytosis in patients after SAE seem comparable to patients who undergo splenectomy, in contrast with average platelet values in those managed with observation alone. So, SAE may be an independent risk factor for thrombotic events in WSES Class II–III (AAST Grades III–V) blunt splenic injuries [Quality of Evidence: Moderate]. Regarding the choice between low molecular weight heparin (LMWH) versus unfractionated heparin (UH), indirect evidence coming from trauma cases in general, and liver trauma specifically, suggests that LMWH is superior to UH for DVT and VTE prevention and may additionally reduce pulmonary embolism (PE) and mortality [Quality of Evidence: Low].

Recommendation. For patients with blunt splenic injuries treated with NOM with/without splenic artery angioembolization (SAE), in the absence of specific complications, the panel suggests that DVT and VTE prophylaxis with LMWH be started within 24 h from hospital admission for patients with WSES Class I (AAST Grades I–II) and within 48–72 h for those with WSES Class II–III (AAST Grades III–V) splenic injuries [Strength of Recommendation: Conditional recommendation, based on Moderate Quality of Evidence, Agreement 91.3%].

Trauma patients are at high risk of deep venous thrombosis (DVT) and venous thromboembolism (VTE), and, without anti-thrombotic prophylaxis, more than 50% of patients may experience thrombotic complications [27, 28]. Thromboelastographic studies have identified a transition from trauma-induced coagulopathy to a hypercoagulable state at 48 h among patients with blunt solid organ injury, suggesting that 48 h might provide the optimal balance of minimizing the risk of both bleeding and VTE [27, 29]. Although DVT and VTE are not life-threatening complications, their association with pulmonary embolism (PE) carries potential morbidity and mortality. After major trauma, the reported mortality rate as a result of PE ranges from 0.4 to 50% [30, 31].

The Western Trauma Association (WTA) suggests starting VTE prophylaxis 24 h post-injury [32], whereas the Eastern Association for the Surgery of Trauma (EAST) recommends starting VTE prophylaxis within 48 h of injury [33]. Studies demonstrating the need for timely DVT prophylaxis initiation showed that a delay in initiation > 4 days is associated with a threefold VTE risk increase [34]. Several prospective and retrospective studies have demonstrated that VTE prophylaxis administration 24–48 h after arrival to the hospital is associated with reduced rates of VTE without increased need for blood transfusion or failure of NOM [35,36,37,38,39]. The 2017 WSES guidelines stated that LMWH-based prophylactic anticoagulation should be started as soon as possible from splenic trauma, including patients treated with NOM [1]. Our systematic review of the literature regarding this topic retrieved 15 studies, of which two were systematic reviews and meta-analyses [40, 41], two were prospective cohort studies [35, 38], and 11 were retrospective cohort studies [27, 28, 36, 37, 42,43,44,45,46,47,48]. To date, two systematic reviews and meta-analyses demonstrated that patients undergoing NOM for blunt solid organ injury could be safely and effectively prescribed early VTE prophylaxis. Murphy et al. [41] included ten studies comprising 14,675 patients that compared early (≤ 48 h) versus late (> 48 h) initiation of VTE chemoprophylaxis in adults with blunt splenic, liver, and/or kidney injury. All studies were non-randomized, and only one was prospective. The overall odds of failure of NOM were not different between early and late groups (OR 1.09; 95% CI 0.92–1.29), and there was no difference in the need for blood transfusion either during overall hospital stay (OR 0.91; 95% CI 0.70–1.18), or post-prophylaxis initiation (OR 1.23; 95%CI 0.55–2.73). The subgroup analysis focused on splenic injuries showed no difference in NOM failure (OR 0.91, 95% CI 0.42–1.97). Conversely, there were significantly lower odds of VTE when patients received early VTE prophylaxis (OR 0.51; 95% CI 0.33–0.81). In keeping with the results presented by Murphy et al., the most updated meta-analysis [

留言 (0)

沒有登入
gif