Evidence Review Process - ESRA
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Laparoscopic Sleeve Gastrectomy 2018

Evidence Review Process

An explanation of PROSPECT methodology and Working Group processes can be found at the following link: PROSPECT methodology primer

For the laparoscopic sleeve gastrectomy review, the Subgroup members were:

Hoani Macfater1

Weisi Xia1

Sanket Srinivasa1

Andrew Graham Hill1

Marc Van De Velde2

Girsh P. Joshi3

  1. Department of Surgery, South Auckland Clinical Campus, Middlemore Hospital, The University of Auckland, Auckland, New Zealand
  2. Department of University Hospital Leuven, Louvain, Belgium
  3. Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, TX, USA

Laparoscopic sleeve gastrectomy (LSG) literature search

  • Systematic review of the literature associated with analgesia after LSG from database inception until 25 September 2018, according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines
  • The following databases were searched: EMBASE, MEDLINE, PubMed and Cochrane databases (Cochrane Central Register of Controlled Trials, Cochrane Database of Abstracts or Reviews of Effects, Cochrane Database of Systematic Reviews) (Search strategy)
  • Included studies were RCTs or systematic reviews in English assessing pain management or prevention using analgesic, anaesthetic, or surgical interventions for adults undergoing LSG. Included studies also required pain intensity measured by VAS or NRS. Studies that did not measure pain intensity and studies that reviewed an analgesic intervention in multiple bariatric procedures were excluded
  • 2245 studies were identified of which 1295 were reviewed in more detail after duplicates were excluded
  • 18 RCTs were included (Summary of literature selection; Included studies). Of these, 17 assessed analgesic or anaesthetic interventions and 1 assessed surgical interventions
  • 11 studies were excluded after full-text screening
  • The reasons for study exclusion were: conference abstracts (4), articles not in English (2), article not specific to LSG (4) and study not randomised (1)

Assessments of the quality of study methodology and reporting

All included studies were assessed for quality as explained below. The study quality assessments are summarised here: Methodological quality summary and Level of Evidence

The criteria used to assess the quality of eligible studies were:

  • CONSORT statement – indication of whether trials met the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement
  • Participant follow-up assessment – whether follow-up was more than or less than 80 percent of the participants
  • Allocation concealment assessment – indication of whether there was adequate guarantee of blinding for treatment assignment (A, adequate; B, unclear; C, inadequate; D, not used)
  • Quality of studies was graded using the Jadad numerical score (total 1–5) using the criteria based on appropriate randomization, double-blinding and statements of possible withdrawals (Jadad 1996)

The level of evidence, a summary of study quality, was determined for each included study based on the above criteria.

  • Summary information for each included study was extracted and recorded in data tables
  • Information retrieved included timing of the intervention, mode of delivery, pain scores, time intervals of pain measurements, supplementary analgesic use, and time to first analgesic administration
  • Pain intensity scores were used as primary outcome measures. Unless specified otherwise, it was assumed that pain scores were assessed at rest
  • The studies were stratified by the timing of the intervention (pre-operative, intra-operative and postoperative) and the type of intervention (analgesic, anaesthetic, or surgical)
  • The effectiveness of each intervention was evaluated qualitatively by assessing the number of studies showing a significant difference between treatment arms (p<0.05 as reported in the study publication)
  • For the purpose of this review, a difference of >10 mm on the VAS or NRS scale was defined as clinically relevant (Myles 2017)

The recommendations were formulated by the interdisciplinary PROSPECT Working Group, using a modified Delphi method to collate rounds of individual comments on the evidence and draft recommendations, followed by round-table discussion, and then further Delphi rounds, to achieve final consensus

PROSPECT recommendations are based on clinical evidence, considering the risks and benefits of interventions as well as study design, including baseline analgesic technique, to determine the relevance of study interventions in current perioperative care practice. Recommendations are given when at least two congruent studies support an intervention

Recommendations for optimal pain relief are graded A–D according to the overall level of evidence, as determined by the quality of studies included, consistency of evidence and source of evidence: Relationship between quality and source of evidence, levels of evidence and grades of recommendation

The literature to recommend an optimal analgesic regimen for LSG is limited. Limitations relate to the design of the included studies:

  • The analgesic interventions were not evaluated against a group that included a basic analgesic regimen (e.g. paracetamol and an NSAID)
  • Heterogeneity and design flaws between studies such as variable dosing regimens, variable methods of administration (e.g. TAP block techniques used in several studies varied substantially), control groups and time points of pain assessment
  • Focus on assessment of pain at rest, without assessment of pain at activity
  • Small size of most studies may lead to an over or under-estimation of effect
  • Small sample size of most studies prevented valid conclusions being drawn regarding the safety profile of analgesic interventions
  • Meta-analysis was not performed due to the limited number of studies with homogeneous design and differences in reporting of results, restricting pooled analysis

The AGREE II instrument (Brouwers 2010) is used internationally to assess the methodological rigour and transparency of practice guidelines. As far as possible, the methodology of the PROSPECT Laparoscopic Sleeve Gastrectomy review meets the requirements of ‘Domain 3: Rigour of development’ of the AGREE II instrument:

  • Systematic methods were used to search for evidence
  • The criteria for selecting the evidence are clearly described
  • The strengths and limitations of the body of evidence are clearly described
  • The methods for formulating the recommendations are clearly described
  • The health benefits, side effects, and risks have been considered in formulating the recommendations
  • There is an explicit link between the recommendations and the supporting evidence
  • The guideline has been externally reviewed by experts prior to its publication. (The evidence and recommendations are made available on the website after peer review and publication)
  • A procedure for updating the guideline is provided. (Methodology is provided so that the systematic review can be updated as required)