Abstract
Background
Gallstone disease is a common gastrointestinal disorder in industrialised countries. Although symptoms can be severe, some people can be symptom free for many years after the original attack. Surgery is the current treatment of choice, but evidence suggests that observation is also feasible and safe. We reviewed the evidence on cholecystectomy versus observation for uncomplicated symptomatic gallstones and conducted a cost-effectiveness analysis.
Methods
We searched six electronic databases (last search April 2014). We included randomised controlled trials (RCTs) or non-randomised comparative studies where adults received either cholecystectomy or observation/conservative management for the first episode of symptomatic gallstone disease (biliary pain or cholecystitis) being considered for surgery in secondary care. Meta-analysis was used to combine results. A de novo Markov model was developed to assess the cost effectiveness of the interventions.
Results
Two RCTs (201 participants) were included. Eighty-eight percent of people randomised to surgery and 45 % of people randomised to observation underwent cholecystectomy during the 14-year follow-up period. Participants randomised to observation were significantly more likely to experience gallstone-related complications (RR = 6.69, 95 % CI = 1.57–28.51, p = 0.01), in particular acute cholecystitis (RR = 9.55, 95 % CI = 1.25–73.27, p = 0.03), and less likely to undergo surgery (RR = 0.50, 95 % CI = 0.34–0.73, p = 0.0004) or experience surgery-related complications (RR = 0.36, 95 % CI = 0.16–0.81, p = 0.01) than those randomised to surgery. Fifty-five percent of people randomised to observation did not require surgery, and 12 % of people randomised to cholecystectomy did not undergo surgery. On average, surgery costs £1,236 more per patient than conservative management, but was more effective.
Conclusions
Cholecystectomy is the preferred treatment for symptomatic gallstones. However, approximately half the observation group did not require surgery or suffer complications indicating that it may be a valid alternative to surgery. A multicentre trial is needed to establish the effects, safety and cost effectiveness of observation/conservative management relative to cholecystectomy.
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Acknowledgments
This review was commissioned by the UK NIHR HTA Programme (project number 12/16)
Disclosures
The authors Drs. Brazzelli, Cruickshank, Ahmed & Avenell; Profs McNamee & Ramsay; Ms Kilonzo; Ms Stewart; MsFraser; and Mr Elders have no conflicts of interest or financial ties to disclose.
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Appendices
Appendix 1: Sample search strategy
Ovid multifile search URL: http://shibboleth.ovid.com/.
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1.
cholecystitis/.
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2.
cholecystitis, acute/.
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3.
cholecystolithiasis/.
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4.
Gallstones/.
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5.
Cholelithiasis/.
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6.
Biliary colic/.
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7.
(gall?bladder adj3 (empyema or inflam$)).tw.
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8.
(biliary colic or gall?stone$ or cholecystitis or cholecystolithiasis).tw.
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9.
((pain or biliary symptom$) adj5 (cholecystitis or cholecystolithiasis or gall?bladder)).tw.
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10.
Or/1-9.
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11.
Exp Cholecystectomy/.
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12.
Cholecystectom$.tw.
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13.
((excis$ or remov$) adj4 gall?bladder).tw.
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14.
((surgery or surgical) adj5 (cholecystitis or cholecystolithiasis or gall?bladder)).tw.
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15.
Or/11-14.
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16.
Exp clinical trial/.
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17.
Randomized controlled trial.pt.
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18.
Controlled clinical trial.pt.
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19.
Randomi?ed.ab.
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20.
Randomly.ab.
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21.
Trial.ab.
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22.
Placebo.ab.
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23.
Drug therapy.fs.
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24.
Groups.ab.
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25.
Comparative study/use prmz.
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26.
(prospective$ or retrospective$).tw.
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27.
(compare$ or compara$).ti,ab.
-
28.
Or/16-27.
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29.
10 and 15 and 28.
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30.
(review or editorial or case report$ or letter).pt.
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31.
Exp animals/not humans/.
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32.
29 not (30 or 31).
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33.
Limit 32 to yr = “1980 -Current”.
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34.
Limit 33 to yr = “2000-Current”.
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35.
Limit 33 to yr = “1980-1999”.
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36.
Remove duplicates from 34.
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37.
Remove duplicates from 35.
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38.
36 or 37.
Appendix 2: Risk of bias summary figure for clinical effectiveness review
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Brazzelli, M., Cruickshank, M., Kilonzo, M. et al. Systematic review of the clinical and cost effectiveness of cholecystectomy versus observation/conservative management for uncomplicated symptomatic gallstones or cholecystitis. Surg Endosc 29, 637–647 (2015). https://doi.org/10.1007/s00464-014-3712-6
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DOI: https://doi.org/10.1007/s00464-014-3712-6