Selective non-operative management, diagnostische laparoscopie en een traumalaparotomie zijn beschreven als behandelstrategie van abdominaal letsel ten gevolge van een trauma. Op dit moment bestaat er geen consensus over wanneer een indicatie is voor een laparoscopie dan wel laparotomie. Van een traumalaparotomie wordt beschreven dat dit sneller is en een betere exposure geeft met mogelijk minder gemist letsel tot gevolgd, echter kent een (non-therapeutische) laparotomie ook weer complicaties.

Quality of life

Description of studies

Systematic reviews

Wang (2022) performed a systematic review and meta-analysis to assess the value of diagnostic and therapeutic laparoscopy for patients with blunt or penetrating abdominal trauma. The databases PubMed, Embase and The Cochrane Library were searched for comparative studies on the effectiveness and safety of laparoscopy versus laparotomy for the management of abdominal trauma, published until the 30^th of June 2021. The search resulted in 1358 studies of which 23 studies were included in the review. Comparative studies comparing laparoscopy with laparotomy for the management of abdominal trauma were selected. Studies in children (<18 years) were excluded). The 23 included studies encompassed one RCT (Leppaniem and Haapiainen, 2003), two prospective observational studies (DeMaria, 2000; Karateke, 2013), and twenty retrospective observational studies, of which four studies were controlled pre- post studydesigns (Cherkasov, 2008; Lee, 2014; Lin, 2010; Omori, 2003) and sixteen studies had a parallel design (Birindelli, 2021; Chakravartty, 2017; Cherry, 2005; Gao, 2020; Huang, 2017; Khubutiya, 2013; Liao, 2014; Lim, 2015; Lin 2018; Marks, 1997; Miles, 2004; Mutter, 1997; Obaid, 2021; Shams and Elaysi, 2021; Trejo-Avila, 2017). Baseline characteristics of the included studies and patients is presented in Table 1. The study populations of the included studies had both blunt and/or penetrating abdominal trauma. In six of the 23 studies, patients with only penetrating trauma were included (total number of patients n = 3309) and in four of the 23 studies, patients with only blunt trauma were included (total numer of patients n = 445). In ten studies patients with both penetrating and blunt injury were included (number patients not specified), or it was not stated if patients had blunt or penetrating injury. In all except two studies, the study population was hemodynamically stable (Cherkasov, 2008; Chestovich, 2015). The patient age varied from 26 to 57 years, with a 76.9% male population. Outcomes that were reported in the review were conversion from laparoscopy to laparotomy, missed injuries, mortality and complications (wound infection, intra-abdominal abscess, pneumonia, thromboembolism, bowel obstruction or ileus). Risk of bias of the individual studies was assessed with the Cochrane Collaboration’s tool (for the RCTs) and the NewCastle Ottawa Scale (for cohort studies).

Table 1: baseline characteristics of the studies included in the review from Wang (2022)

HD = hemodynamic; I = intervention (laparoscopy); C = control (laparotomy)

Observational studies

Alzarouni (2022) performed a retrospective cohort study on the role of laparoscopy in abdominal trauma. Medical records were used from patients presenting with abdominal trauma in a level-I trauma centre in the United Arab Emirates. Records from adult patients (> 18 years), hemodynamically stable, with blunt or penetrating abdominal trauma requiring abdominal surgical intervention were included (n = 154). Patients with persistent hypotension, unresponsive to fluid resuscitation were excluded from this study. Mean age of the study population was 32.4 years, 90.9% was male and 63.6% had blunt trauma. Other baseline characteristics are presented in Table 2. In blunt abdominal trauma, a CT-scan was performed for every hemodynamically stable patient after fluid resuscitation and FAST examination. In penetrating abdominal trauma, the decision for surgical intervention depended on the clinical examination of each individual patient, regardless of the CT-scan evaluation. Initially, 57 patients underwent laparoscopy, and 97 patients underwent laparotomy. Of the 57 patients undergoing initial laparoscopy, 18 patients were converted to laparotomy. Outcomes included missed injuries and complications. Moreover, it was reported whether laparoscopy and laparotomy were therapeutic or non-therapeutic. There was no correction for confounding variables.

Elkbuli (2022) performed a retrospective cohort study with 1:1 propensity matching to compare patient outcomes between laparoscopy and laparotomy approaches in patients with single penetrating left upper quadrant injuries. Data from the American College of Surgeons (ACS) Trauma Quality Program (TQP) Participant Use File (PUF), including data from 700+ American Trauma centres was used. Patients aged 18 – 90 with single penetrating injuries to the left upper quadrant and/or left hemithorax who received laparoscopy or laparotomy were included for analysis. Patients who were dead on arrival, and patients with sustained traumatic brain injuries, blunt injuries, or two or more gun or stab wounds were excluded from the analysis. Patients in the laparoscopy (n = 486) and laparotomy (n = 486) group were matched using the following variables: age, gender, race, insurance status, injury type, injury severity score (ISS), comorbidities, trauma center level, and hospital bed size. The baseline variables appeared to be equally distributed across both groups, see Table 2. Both hemodynamically stable and hemodynamically unstable patients were included. The indications for either laparoscopy or laparotomy were not reported. Of the total study population, 2.4% underwent laparoscopy to laparotomy conversion, these patients were included in the laparotomy group.

Gomez (2022) performed a retrospective cohort study to investigate the feasibility and safety of laparoscopy in the treatment of stable penetrating abdominal trauma in a limited resources environment. Hospital records of patients presenting with stable penetrating abdominal trauma at a Colombian hospital were selected (n = 52). Patients younger than 16 years, patients with other body parts injuries and patients that had undergone successful non-operative management were excluded from the analysis. Indications for laparoscopy or laparotomy were not reported. Laparoscopy encompassed diagnostic laparoscopy, assisted laparoscopy and fully therapeutic laparoscopy. In the laparoscopy group, all patients were hemodynamically stable. In the laparotomy group, 75.4% of the patients was hemodynamically stable, see Table 2. Two patients from the laparoscopy group converted to laparotomy. Missed injuries, mortality, reintervention, complications, and conversion to laparotomy were reported as outcomes. There was no correction for confounding variables.

Table 2: baseline characteristics of the observational studies

HD = hemodynamic; I = intervention (laparoscopy); C = control (laparotomy)

Results

Missed injuries

Nineteen studies included in the review from Wang (2022) reported the outcome missed injuries. These results were pooled in a meta-analysis. The majority of studies did not report any missed injuries in the laparoscopy or laparotomy group. The pooled number of missed injuries in the laparoscopy group was 13/2524 (0.5%), compared to 46/2805 (1.6%) of the patients undergoing laparotomy. The pooled Risk Difference (RD) was -0.00 (95% CI -0.00 to 0.00), see Figure 1.

Figure 1. Forest plot showing the comparison between laparoscopy and laparotomy for the outcome missed injuries. Pooled risk difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; SD: standard deviation; I²; statistical heterogeneity; CI: confidence interval.

Alzarouni (2022) and Gomez (2022) also reported missed injuries, however in both studies only information about missed injuries in the laparoscopy group. As a consequence, a Risk Ratio (RR) or RD could not be calculated. Both studies reported no missed injuries in the patients undergoing laparoscopy (n = 57 and n = 26 respectively)

Mortality

Twenty studies included in the review from Wang (2022) and Gomez (2022) reported the outcome mortality. These results were pooled in a meta-analysis. The majority of studies did not report mortality cases in the laparoscopy or laparotomy group. The pooled mortality rate in the laparoscopy group was 123/2169 (5.7%), compared to 213/2572 (8.3%) of the patients undergoing laparotomy. The pooled Risk Difference (RD) was -0.01 (95% CI: -0.03 to 0.00), see Figure 2.

Figure 2. Forest plot showing the comparison between laparoscopy and laparotomy for the outcome mortality. Pooled risk difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; SD: standard deviation; I²; statistical heterogeneity; CI: confidence interval.

Elkbuli (2022) calculated an adjusted Odds Ratio (OR) for mortality after matching patients in the laparoscopy group with patients in the laparotomy on multiple variables. In the laparoscopy group 1.2% mortality was reported, compared to 2.9% in the laparotomy group. The adjusted OR was 2.92 (95% CI: 0.32 to 26.31).

Reintervention

Five studies included in the review from Wang (2022) reported the outcome reintervention. In these studies re-intervention was defined as non-planned re-exploration. The results were pooled in a meta-analysis. The pooled number of reinterventions in the laparoscopy group was 2/470 (0.4%), compared to 16/660 (2.4%) of the patients undergoing laparotomy. The pooled RD was -0.01 (95% CI: -0.03 to 0.01), see Figure 3.

Figure 3. Forest plot showing the comparison between laparoscopy and laparotomy for the outcome reintervention. Pooled risk difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; SD: standard deviation; I²; statistical heterogeneity; CI: confidence interval.

Gomez (2022) stated that “no reintervention (…) was reported” in the laparoscopy group. Data on reintervention rates in the laparotomy group was not reported.

Complications

Overall complications

Three studies (Alzarouni, 2022; Elkbuli, 2022, Gomez 2022) reported overall complication rates for the laparoscopy and laparotomy group, see Table 3. In Alzarouni (2022), complications were classified as surgical site infections, pulmonary complications, urinary tract infections, intra-abdominal collection and others. In Elkbuli (2022) and Gomez (2022) complications were not specified.

Table 3: resuts for the outcome complications (overall complication rate)

RD = Risk Difference; CI = confidence interval; OR = Odds Ratio

In the review from Wang (2022) sub-analyses were made for different types of complications: wound infections, intra-abdominal abcess, pneumonia and bowel obstruction or ileus.

Wound infection

Seventeen studies included in the review from Wang (2022) reported the outcome wound infection These results were pooled in a meta-analysis. The pooled number of wound infection cases in the laparoscopy group was 52/2055 (2.5%), compared to 117/2416 (4.8%) of the patients undergoing laparotomy. The pooled RD was -0.03 (95% CI: -0.06 to -0.01), see Figure 4.

Figure 4. Forest plot showing the comparison between laparoscopy and laparotomy for the outcome wound infections (complication). Pooled risk difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; SD: standard deviation; I²; statistical heterogeneity; CI: confidence interval.

Intra-abdominal abcess

Fifteen studies included in the review from Wang (2022) reported the outcome pneumonia. These results were pooled in a meta-analysis. The pooled number of cases of intra-abdominal abcess in the laparoscopy group was 7/595 (1.2%), compared to 14/744 (1.8%) of the patients undergoing laparotomy. The pooled RD was -0.00 (95% CI: -0.02 to 0.01), see Figure 5.

Figure 5. Forest plot showing the comparison between laparoscopy and laparotomy for the outcome intra-abdominal abcess (complication). Pooled risk difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; SD: standard deviation; I²; statistical heterogeneity; CI: confidence interval.

Pneumonia

Twelve studies included in the review from Wang (2022) reported the outcome pneumonia. These results were pooled in a meta-analysis. The pooled number of pneumonia cases in the laparoscopy group was 17/1636 (1.0%), compared to 17/1799 (4.4%) of the patients undergoing laparotomy. The pooled RD was -0.03 (95% CI: -0.05 to -0.02), see Figure 6.

Figure 6. Forest plot showing the comparison between laparoscopy and laparotomy for the outcome pneumonia (complication). Pooled risk difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; SD: standard deviation; I²; statistical heterogeneity; CI: confidence interval.

Bowel obstruction or ileus

Fourteen studies included in the review from Wang (2022) reported the outcome pneumonia. These results were pooled in a meta-analysis. The pooled number of bowel obstruction or ileus cases in the laparoscopy group was 9/1712 (0.5%), compared to 114/1880 (6%) of the patients undergoing laparotomy. The pooled RD was -0.03 (95% CI: -0.07 to -0.00), see Figure 7.

Figure 7. Forest plot showing the comparison between laparoscopy and laparotomy for the outcome bowel obstruction or ileus (complication). Pooled risk difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; SD: standard deviation; I²; statistical heterogeneity; CI: confidence interval.

Quality of life

None of the studies reported the outcome ‘quality of life’.

Conversion (from laparoscopy to laparotomy)

The majority of studies reported conversion from laparoscopy to laparotomy. As this outcome measure only applies to the laparoscopy group, a comparative analysis could not be made and the GRADE-approach could not be applied. Nevertheless, the guideline development group considered these data relevant for this guideline. Wang (2022) reported that the average rate of conversion from laparoscopy to laparotomy was 25% (range: 0 – 45.1%). The data is presented below.

Table 3: laparoscopy to laparotomy conversion as reported in the included studies.

Level of evidence of the literature

The level of evidence regarding the outcome measure missed injuries was retrieved from observational studies and therefore started ‘low’. The level of evidence was downgraded by one level because of study limitations including lack of adequate correction for confounding factors (-1 risk of bias). The final level of evidence was ‘very low’.

The level of evidence regarding the outcome measure mortality was retrieved from observational studies and therefore started ‘low’. The level of evidence was downgraded by one level because of study limitations including lack of adequate correction for confounding factors (-1 risk of bias). The final level of evidence was ‘very low’.

The level of evidence regarding the outcome measure reintervention was retrieved from observational studies and therefore started ‘low’. The level of evidence was downgraded by two levels because of study limitations including lack of adequate correction for confounding factors (-1 risk of bias) and the wise 95% confidence intervals, crossing the thresholds of minimal clinically (patients) important difference (-1 imprecision). The final level of evidence was ‘very low’.

The level of evidence regarding the outcome measure complications was retrieved from observational studies and therefore started ‘low’. The level of evidence was downgraded by one level because of study limitations including lack of adequate correction for confounding factors (-1 risk of bias). The final level of evidence was ‘very low’.

The level of evidence regarding the outcome measure ‘quality of life’ was not graded as it was not reported in the included studies.

The level of evidence regarding the outcome measure ‘conversion’ was not graded as it was not possible to make a comparison between the intervention (laparoscopy) and control (laparotomy)

A systematic review of the literature was performed to answer the following question:

What are the risks and benefits laparoscopy compared to laparotomy in patients with traumatic abdominal injury?

P = patients with traumatic abdominal injury

I = laparoscopy

C = laparotomy

O = missed injuries, mortality, conversion, re-intervention, complications, quality of life

Relevant outcome measures

The guideline development group considered missed injuries and mortality as a critical outcome measure for decision making; and conversion, reintervention, complications and quality of life as an important outcome measure for decision making.

A priori, the guideline development group did not define the outcome measures listed above but used the definitions used in the studies.

The guideline development group defined a relative risk (RR) of <0.90 and >1.10 and a risk difference (RD) of 10% as a minimal clinically (patient) important difference for the outcomes mortality and missed injuries. For the outcomes reintervention and complications a threshold of 25% was set as a minimal clinically (patient) important difference (0.80 < RR > 1.25 and RD 25%) set as a minimal clinically (patient) important difference. For quality of life (continuous outcome) a difference of 20% was considered clinically important.

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until February 26, 2023. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 1476 hits. Studies were selected based on the following criteria: systematic reviews, randomized controlled trials and comparative observational studies comparing laparoscopy with laparotomy for the treatment of abdominal trauma. Seventeen studies were initially selected based on title and abstract screening. After reading the full text, twelve studies were excluded (see the table with reasons for exclusion under the tab Methods), and five studies were included.

Results

One systematic review and four observational studies were included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.