Critical Appraisal: S.R. and Meta-Analysis for Laparoscopy vs. Open Colon Surgery with or without an ERAS Programme – Spanjersberg et al, 2014
This critical appraisal was undertaken using CASP Systematic Review Checklist (31.05.13) as reference and the analysis has been presented in two sections: strengths and weaknesses.
The review and analysis are thorough and well structured with stated rationale*, objectives and clear primary and secondary outcomes – (to ascertain if Laparoscopic surgery has additional value with ERAS for Colorectal patients: evaluating when all patients receive:
a) ERAS with either Laparoscopy or open surgery; and
b) Laparoscopy with or without ERAS) and clear end points.
*no previous meta-analysis has been conducted looking at ERAS and Laparoscopy. (This appraiser undertook a preliminary search using Cochrane Library and found this to be true).
Methodology is rigourous, giving measurable inclusion and exclusion criteria and thorough data analysis.
Results are well presented and easy to interpret and the discussion valid and inclusive of reference to and relevance of, other pertinent studies and comprehensive explanation of the limitations of the review and analysis.
The study includes 3 RCTs and 5 CCTs (there is an inaccuracy in the ‘Abstract’, where it states there are 6 CCTs in the Review and not all could be used for each parameter. It is arguable that this is a questionable number to give significance especially since the authors state that the quality of the information analyzed is ‘moderate to poor’.
The number of patients involved (942) is not evenly distributed amongst the study areas – 408 for Laparoscopy & ERAS; 189 for Laparoscopy & conventional care; 249 for open and ERAS. The 98 patients receiving open surgery and conventional care are not reported on with regard to the data potentially available from this analysis.
The emphasis of the study – the value added by laparoscopy within an ERAS programme – is confusing. Laparoscopic surgery is one of the key components of the 17 Grade A recommendations given, subject only to availability of trained staff, which, at the time of publishing was likely to have been more of an issue than at the time this study was undertaken.
The authors state that they have used data spanning a number of years, which obviously could influence the results, but overall, the number of patients receiving laparoscopic surgery versus open is much greater (597 vs. 247).
The authors use a ‘data extraction sheet’ specially devised to record information, but this is not provided in the report.
It is not clear why the authors have chosen to report on the specific outcomes they have or their rationale for which are ‘primary’ and which ‘secondary’ (The latter are not covered in the data extraction and quality assessment with regard to method). They make a passing comment on other parameters such as mobilization but not a comprehensive breakdown of all the ERAS criteria, where available.
They state that inclusion is a minimum of 7 ERAS protocols for trials that include ERAS and conventional care are trials that have 2 or less ERAS protocols, in order to make viable comparison. (These inclusion criteria are actually identified in the exclusion criteria). However, in the summary table (Fig. 2) and Discussion the authors report that a bias factor could be the lack of adherence to protocol in the ERAS trials and use of around 6 items in the conventional care groups. This is a confusing inconsistency. Commentary is not given as to whether there are some elements of ERAS that are more influential than others. This would add value to the study in terms of clinical application and consistency.
The authors also cite, on several occasions (4), as a key reference a previous study conducted by two of their team, which could add an element of bias to the review.
Their findings show that there is little difference between outcomes when laparoscopic surgery is used with or without ERAS and refer to a previous study, of their own, to say that ERAS is effective with open surgery. Since the data on ERAS and conventional care was potentially available to the authors from this study also, this point could have been validated or refuted, but was not.
In summary, the key factor which limits this analysis and review, is the quality of data the authors found available for use and the potential bias of comparative ‘retrospective study’ data, thus marginalizing the claim that laparoscopic surgery enhances ERAS protocols with regard to ‘major’ morbidity factors and length of hospitalization.”
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