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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Staple line reinforcement in laparoscopic bariatric surgery: does it actually make a difference? A systematic review and meta-analysis

GA Giannopoulos, NE Tzanakis, GE Rallis, SP Efstathiou, C Tsigris, and NI Nikiteas.

Review published: 2010.

Link to full article: [Journal publisher]

CRD summary

The review found that staplers in bariatric surgery may not be uniformly reliable and staple line reinforcement did not seem to have any clear benefit for reduction of leaks. Wide variation between the studies, discrepancies between figures and text and potential bias in the review process mean the authors' conclusions should be viewed with caution.

Authors' objectives

To assess the effectiveness of staple line reinforcement in laparoscopic bariatric surgery.

Searching

PubMed and The Cochrane Library were searched without restrictions for relevant studies. Search terms were reported. Search dates were not reported. Reference lists of retrieved studies were searched. The initial search was widened to include all surgical procedures.

Study selection

Eligible studies were randomised controlled trials (RCTs) and non RCTs that provided detailed description of operative bariatric techniques (laparoscopic Roux-en-Y gastric bypass (LRYGBP), laparoscopic vertical banded gastroplasty (LVBG) and laparoscopic sleeve gastrectomy (LSG)) and potential staple reinforcement (suture reinforcement, fibrin sealant, buttressing material and combination of buttressing and fibrin sealant). The sole eligible outcome was postoperative staple line leak confirmed either by radiologic upper gastrointestinal study or by reoperation.

In the included studies, most of the bariatric surgery procedures were LRYGBP.

Two reviewers selected studies for inclusion in the review.

Assessment of study quality

The authors did not state whether studies were evaluated for quality.

Data extraction

Data were extracted on the percentage of postoperative staple line leak according to type of reinforcement. Population odds with 95% confidence intervals (CIs) were calculated for seven studies that reported staple line leaks. Relative risks (RRs) with 95% CIs were calculated for three controlled studies that made comparisons between groups.

The authors did not state how many reviewers performed data extraction.

Methods of synthesis

All studies were synthesised in narrative format and results (proportion with staple line leaks) were reported in a table. Studies that reported staple line leaks were pooled in meta-analysis and summary population odds with 95% CIs were calculated. Controlled studies that made comparisons of staple line leaks between groups were pooled in meta-analysis and summary relative risks with 95% CIs were calculated. Meta-analyses used the DerSimonian and Laird random-effects model. Heterogeneity was assessed with the X2 test and the I2 value. A funnel plot was created to assess the likelihood of publication bias in the three controlled studies that made group comparisons.

Results of the review

The authors stated that 17 studies were included in the review, but only 16 studies (n=4,061 participants) were listed in the table of overall results. Three studies were RCTs. The authors stated that nine of the 16 studies listed in the table of results had no control group; there was a discrepancy in this estimate, as the study by Chen appeared to have a control group.

The overall proportion of participants with leaks (with and without reinforcement) ranged from zero to 10%. In seven studies that reported any leaks (n=3,299), the population odds of leaks was 7.69% (95% CI 3.44 to 17.18). In three controlled studies (n=1,899), no reinforcement was associated with a marginally statistically significant decrease in the risk of leaks (RR 0.95, 95% CI 0.92 to 0.99) compared to reinforcement, with moderate to large heterogeneity. The funnel plot of the three controlled studies showed an asymmetric relationship.

Estimates in the forest plot that included three controlled studies did not correspond with the raw figures in the table. In the table, a higher rate of leaks was reported for one study (Jones) in the no reinforcement group in comparison to the reinforcement group and in another study (Chen) a lower rate of leaks was reported in the no reinforcement group in comparison to the reinforcement group. The forest plot displayed both estimates (Jones and Chen) to the right on the vertical no difference line, which suggested similar relative risks.

Authors' conclusions

Staplers may not be uniformly reliable and staple line reinforcement did not seem to have any clear benefit for reduction of leaks.

CRD commentary

The review addressed a clear research question. The broad inclusion criteria appeared appropriate. A limited unrestricted search was undertaken of two electronic databases, supplemented with searching reference lists. No explicit attempts were made to find unpublished studies and the funnel plot of the three controlled studies showed an asymmetric relationship, so publication bias could not be ruled out. Appropriate methods were used for study selection of studies; no such methods were reported for data extraction, so reviewer error and bias could not be ruled out. The included studies were not assessed for quality and this made it difficult to interpret the reliability of results. Few of the studies were controlled and most appeared to be case series.

Synthesis of the studies in narrative format to assess the leak rate was appropriate given the variation in study design and type of operation and reinforcement used, although some studies used no reinforcement. There was a discrepancy between the number of studies reported in the text and table. Population odds of staple leak was calculated only in studies that reported leaks, so the summary estimate was relevant only to situations where leaks were reported. The synthesis of three RCTs in a meta-analysis was appropriate, but moderate to high heterogeneity meant that the overall estimates may not have been reliable. A discrepancy was found between the raw figures on leak rates in the text and tables compared to the individual study relative risks in the forest plot.

Wide variation between the studies, discrepancies between figures and text and potential bias in the review process mean the authors' conclusions should be viewed with caution.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice.

Research: The authors stated that more RCTs were required to assess the effectiveness of staple line reinforcement.

Funding

Not stated.

Bibliographic details

Giannopoulos GA, Tzanakis NE, Rallis GE, Efstathiou SP, Tsigris C, Nikiteas NI. Staple line reinforcement in laparoscopic bariatric surgery: does it actually make a difference? A systematic review and meta-analysis Surgical Endoscopy 2010; 24(11): 2782-2788. [PubMed: 20396908]

Indexing Status

Subject indexing assigned by NLM

MeSH

Anastomosis, Surgical; Bariatric Surgery; Endoleak /prevention & control; Humans; Laparoscopy; Obesity, Morbid /surgery; Surgical Stapling

AccessionNumber

12010008227

Database entry date

26/10/2011

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 20396908

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