Eighteen studies6,7,21,28,31,32,35–39,41,42,44–47 on 899 patients managed with GDFT versus 914 patients with traditional fluid management reported morbidity rates (Fig. 2). These were further divided by whether the patients had been managed as part of an ERAS pathway (866 patients) or as part of a traditional care pathway (947 patients). One study30 focused on cardiac morbidity alone, but these data are included in the overall analysis. Overall morbidity was significantly lower in patients managed with GDFT versus those in the control group (RR 0.76, 95% CI 0.66–0.89, P = 0.0007). When just those managed with GDFT in a traditional care pathway setting were considered, morbidity rates were also significantly lower in the GDFT group when compared with controls (RR 0.69, 95% CI 0.57–0.84, P = 0.0002). However, when the GDFT was administered in conjunction with an ERAS pathway, it did not result in a reduction in morbidity risk (RR 0.86, 95% CI 0.70–1.05, P = 0.14). The funnel plot for the primary outcome measure of morbidity showed no major asymmetry to indicate a significant bias in either group.
Mortality rates were detailed in 18 studies6,7,21,28,29,32,35,37–47 that included 855 patients in the GDFT group and 870 in the traditional group (Fig. 3). Overall, there was no statistically significant difference in the incidence of mortality between GDFT and control patients, nor was there any difference in those managed with an ERAS pathway or traditional care.
Hospital Length of Stay
Overall hospital LOS was reported in all studies except one32 included in the meta-analysis (Fig. 4). However, 2 studies30,34 reported only median (IQR) data, and we were unable to obtain the mean ± SD from the authors. These data were estimated using the technique described by Hozo et al.24 and all data were included in the analysis of hospital LOS. There were 1043 patients managed in an ERAS setting and 1014 in a traditional setting (Fig. 4). GDFT resulted in a significant decrease in hospital length of stay in the overall group (mean difference −1.55 days, 95% CI −2.73 to −0.36, P = 0.01). If patients managed in a traditional care setting were specifically examined, GDFT again resulted in a significant reduction in overall hospital LOS (mean difference −2.14 days, 95% CI −4.15 to −0.13, P = 0.04). However, there was no significant difference in hospital LOS in those managed with an ERAS pathway (mean difference −0.71 days, 95% CI −1.91 to 0.49, P = 0.25).
Intensive Care Length of Stay
Postoperative LOS in the ITU was reported in 8 studies28,30,32,41–44,46 (Fig. 4). Again, 3 studies30,44,46 provided only median (IQR) data; therefore, estimated mean ± SD data were included for these studies. Only 1 study in an ERAS setting reported intensive care LOS,30 whereas 7 studies in a traditional setting reported this. GDFT resulted in a significant reduction in intensive care LOS (Fig. 4) in all patients (mean difference −0.63 days, 95% CI −1.18 to −0.09, P = 0.02) and in the 1 study in which patients were managed with an ERAS pathway (mean difference −0.63 days, 95% CI −0.94 to −0.32, P < 0.0001). GDFT, however, made no significant difference to intensive care LOS in those patients managed within a traditional care setting.
Return of Gastrointestinal Function
Eleven studies examined time to return of gastrointestinal function postoperatively, in the form of passage of flatus,28,31,38 feces,6,29,33,35,45 or both.30,39,40 First, considering time to passage flatus in all studies including those with calculated data (Fig. 5), there were 334 patients who were managed with GDFT and 345 in the control group. There was no significant difference in the time to passage of flatus in either the overall group or in those managed in combination with traditional care or an ERAS pathway.
When time to passage of feces was considered, 365 patients were managed with GDFT and 370 with control intraoperative fluid (Fig. 5). GDFT resulted in a significant reduction in time to passage of feces in the overall group (mean difference −0.90 days, 95% CI −1.48 to −0.32 days, P = 0.002) as well as those managed with GDFT in combination with an ERAS pathway (mean difference −1.09 days, 95% CI −2.03 to −0.15, P = 0.02). However, this difference was not significant in patients managed in a traditional care setting.
Incidence of Postoperative Ileus
Seven studies (707 patients) included data on the incidence of postoperative ileus in 345 patients managed with intraoperative GDFT versus 362 patients in the control group6,21,28,36–38,40 (Fig. 5). The use of GDFT did not affect the incidence of postoperative ileus significantly in either the overall group or in those managed in combination with either traditional care or an ERAS pathway.
This meta-analysis of 23 randomized controlled trials including 2099 patients has demonstrated that, in patients undergoing elective major abdominal surgery, GDFT was associated with a significant reduction in overall morbidity, LOS (both hospital and intensive care), and time to passage of feces when compared with conventional intraoperative fluid therapy when all studies were considered. However, there were no significant differences in short-term mortality, time to passage of flatus, or risk of paralytic ileus.
When the effect of GDFT was considered in the setting of ERAS pathways, which are being implemented increasingly internationally, there was no statistically significant impact on morbidity and mortality, hospital LOS, time to passage of flatus, or incidence of paralytic ileus. A significant reduction in intensive care LOS with GDFT was seen, but this was based on a single study.30 When the impact of GDFT was considered in the setting of a traditional care pathway, a significant reduction in morbidity and overall hospital LOS was seen when compared with controls, but there was no significant difference in any other outcome considered.
The studies included in this meta-analysis were conducted over a 12-year period during which significant advances have been made in the concept and implementation of ERAS principles and there is evidence that ERAS programs are associated with reduced hospital LOS,19,48,49 decreased morbidity, and improved cost-effectiveness.50 The studies were conducted in a variety of surgical specialties which have differing expected LOS; however, if the studies examining colorectal surgery alone are analyzed,6,21,36–39,45 LOS has declined progressively over a temporal scale from 12.0 ± 7.5 days in 200545 to 7.48 ± 3.8 days in 2014.21 With the ongoing push for decreasing LOS, reinforced by recent reports of 2-day51 and 23-hour52 hospital stays for laparoscopic colorectal resection, the margin for overall improvement in LOS provided by GDFT may decrease. Overall heterogeneity was high for LOS (90%) and, although it reduced to 61% for the ERAS group, it was still high. Therefore, it is not certain whether the lack of difference in the LOS in the ERAS subgroup was a time-dependent effect or a reflection of the effect of ERAS pathways.
The other issue raised by the temporal spread of the results is that of the volume of fluid infused intraoperatively. This volume has changed drastically from the earliest to more recent papers, with a progressively greater difference in volume infused between GDFT and conventional fluid management groups, suggesting that the concept and impact of GDFT may have changed during this period. It is possible that, in the early phase of introduction of GDFT, patients were being frequently fluid overloaded intraoperatively. Given that postoperative morbidity is associated in a U-shaped manner with the volume of intraoperative fluid infused,51 excessive fluid administration in some of these studies may have attenuated some of the potential benefits of GDFT. Further to this, the majority of early studies did not consider the importance of postoperative salt and water overload, which may also have impacted negatively on outcome. In contrast, near-zero fluid balance is considered more carefully in recent studies due to advancing knowledge of the importance of these factors52 in the perioperative setting. The provision of high–chloride-containing fluids, with the resultant undesirable hyperchloremic acidosis,53–55 may also have masked some benefits provided by GDFT. Worldwide, there is now a move away from 0.9% saline-based fluids to balanced crystalloids and colloids, and this may lead to a further improvement in outcomes.56 One further factor to consider is that different studies have employed different goals for GDFT, and the emphasis of this has evolved over time. In the earlier studies included in this meta-analysis, patients were given fluid boluses if they were fluid responsive, regardless of their hemodynamic status, to maximize stroke volume by pushing patients to the top of their Frank–Starling curve. This approach is likely to result in fluid overload by “optimizing” patients to a point where they are no longer fluid responsive rather than assessing “good enough” resuscitation. In contrast, more contemporary studies administer bolus fluid only if patients were fluid responsive and had evidence of hemodynamic compromise, which may be reflected in the overall smaller volumes administered in more recent studies where a target of near-zero fluid balance was employed.
The present study was conducted using rigorous methodology and represents the largest meta-analysis examining the role of GDFT versus conventional intraoperative fluid management in patients undergoing elective major abdominal surgery. Not only did we set out to establish the difference in clinical outcome measures but also at the outset a secondary outcome of comparing those managed within ERAS pathways with those who were managed in traditional care setting was specified. This secondary analysis has resulted in some interesting observations in outcomes between the 2 settings, which appear to differ considerably. A further strength was that to ensure the data were as complete as possible for all studies included, most importantly the mean ± SD data for continuous variables, all authors were contacted on 3 separate occasions requesting the necessary raw data rather than the median (IQR). Unfortunately, not all authors responded to the request for information, and data for several studies30,34,40,44 were estimated for inclusion in the meta-analysis. This estimation was done using an established method24 that has been employed in other meta-analyses.
This meta-analysis had several weaknesses inherent in its design and conduct. The methodology for conducting GDFT differed greatly between studies, including TED,6,7,21,34–40,45,46 hemodynamic parameters from an arterial line,29–33,42–44,47 pleth variability index from the pulse oximeter,41 and a noninvasive cardiac output monitoring device.28 Inclusion of all techniques for conducting GDFT was chosen purposefully to ensure that the conclusions of this meta-analysis were generalizable to different GDFT methods. However, subgroup analyses comparing the various methods was not feasible because of the small numbers of patients who were managed with techniques other than TED or monitoring of hemodynamic parameters from arterial lines. One factor that was not measured consistently between the studies was that of postoperative fluid administration and overall balance, which may significantly impact upon some of the postoperative outcomes. The use of rescue therapy such as diuretics and inotropes is also difficult to discern from the studies. None of the ERAS pathway studies included an assessment of compliance with the ERAS standards, which is particularly important because of the correlation between compliance with the standards and clinical outcomes.57–59
There was a large degree of heterogeneity in the studies included in this review. Using the I2 statistic26 for the 7 clinical outcomes, 1 outcome had low (I2 < 25%), 3 had moderate (I2 25%–50%), and 3 had high heterogeneity (I2 > 50%). This great variation may have impacted upon the significance of the results. In addition, to improve generalizability, we included all studies that included patients who had major abdominal surgery where the bowel was handled. It was also not possible to differentiate the effects of temporal changes in perioperative management algorithms and other treatment interventions such as the use of vasopressors from the effect of GDFT.
NICE guidance12 released in 2011 on the use of TED-guided fluid therapy has recommended its use “in patients undergoing major or high-risk surgery or other surgical patients in whom a clinician would consider using invasive cardiovascular monitoring.” However, this guidance was made mainly on the findings of older studies, some of which were on patients undergoing cardiac and hip fracture surgery and most of which were conducted within a traditional setting of perioperative care. All studies included in the present meta-analysis focused on patients who would meet the criteria for major or high-risk surgery, making this meta-analysis an excellent setting in which to examine the potential benefits of this technique. By comparing the older studies with newer studies that have been conducted using multimodal enhanced recovery perioperative care pathways, we have shown in our meta-analysis that modern perioperative care reduces the impact of GDFT on outcome. This could help inform healthcare providers better and facilitate a more rational decision-making process before recommending GDFT as “standard of care.” Given the unclear benefits of GDFT found in this study, particularly in those managed within an ERAS pathway, it is uncertain whether this recommendation ought to be adopted for all patients undergoing elective major abdominal surgery.
The bolus fluid administered as part of the GDFT protocol in the included studies was variable, with HES being the documented fluid administered in 14 studies.7,21,28,29,32,34,35,37,39,41–44,46 However, there has recently been a moratorium in Europe on the use of HES due to concerns of increased risk of acute kidney injury requiring renal replacement therapy,60–62 as well as mortality60,62 based on recent randomized controlled trials in critically ill patients. Given that much of the evidence in this study, as well as other meta-analyses, are based upon the use of HES as the bolus fluid administered for GDFT, the impact of GDFT using gelatin (or other colloid)-based fluid may differ from current evidence. Further literature63 has examined the role of balanced crystalloid (Hartmann solution) versus colloid (6% HES) as the bolus agent for GDFT, demonstrating no clinical benefit from colloid in terms of morbidity or coagulopathy. Only 2 of the studies included in this meta-analysis30,47 administered crystalloid as the bolus agent. Crystalloids may be increasingly utilized in future studies regarding GDFT due to suggested therapeutic equivalence of colloid and crystalloid in combination with concerns with regard to some forms of colloid.
An updated meta-analysis on perioperative administration of fluids, with or without inotropes/vasoactive drugs, targeted to increase blood flow (relative to control) against measured goals in patients undergoing abdominal and extra-abdominal surgery, including emergency procedures showed that patients randomized to a hemodynamic therapy algorithm, had fewer complications and shorter LOS than controls.64 Nevertheless, the findings of the present meta-analysis for patients managed within ERAS pathways are in agreement with a previous meta-analysis of 6 trials of 691 patients undergoing elective colorectal surgery in which it was shown that TED-guided GDFT did not influence LOS or complications.65
However, although the benefits of GDFT on clinical outcomes may be marginal, the presence of an important benefit such as cost savings cannot be ruled out on the basis of this meta-analysis. Further large-scale randomized trials addressing all the issues that we have highlighted, including a cost-effectiveness analysis, are necessary before the real impact of GDFT in elective abdominal surgery is known.
This meta-analysis has shown that the benefits of GDFT may not be as clear as has been suggested historically. The overall perioperative management of patients has changed during the period of inclusion of studies in this meta-analysis, including decreasing expected hospital LOS, overall decreasing volumes of intraoperative fluid infusion, avoidance of postoperative salt and water overload, and introduction and compliance with ERAS programs. Despite the NICE Guidance12 which recommends that GDFT technology should be used “in patients undergoing major or high-risk surgery,” this study suggests that GDFT may not be of use to all elective patients undergoing major abdominal surgery. The benefit conveyed by GDFT is particularly attenuated by its combination with ERAS pathways that are being increasingly implemented internationally. GDFT may be more of use in the intraoperative care of high-risk patients; however, as yet, there are no definitive data to support this belief.
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