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Miriam Brazzelli 1,*, Moira Cruickshank 1, Mary Kilonzo 2, Irfan Ahmed 3, Fiona Stewart 1, Paul McNamee 2, Andrew Elders 1, Cynthia Fraser 1, Alison Avenell 1, Craig Ramsay 1

1 Health Services Research Unit, University of Aberdeen, Aberdeen, UK
2 Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
3 NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK
* Corresponding author Email:

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The full text of this issue is available as a PDF document from the Toolkit section on this page.

Abstract

BACKGROUND

Approximately 10-15% of the adult population suffer from gallstone disease, cholelithiasis, with more women than men being affected. Cholecystectomy is the treatment of choice for people who present with biliary pain or acute cholecystitis and evidence of gallstones. However, some people do not experience a recurrence after an initial episode of biliary pain or cholecystitis. As most of the current research focuses on the surgical management of the disease, less attention has been dedicated to the consequences of conservative management.

OBJECTIVES

To determine the clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management in people presenting with uncomplicated symptomatic gallstones (biliary pain) or cholecystitis.

DATA SOURCES

We searched all major electronic databases (e.g. MEDLINE, EMBASE, Science Citation Index, Bioscience Information Service, Cochrane Central Register of Controlled Trials) from 1980 to September 2012 and we contacted experts in the field.

REVIEW METHODS

Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies that enrolled people with symptomatic gallstone disease (pain attacks only and/or acute cholecystitis). Two reviewers independently extracted data and assessed the risk of bias of included studies. Standard meta-analysis techniques were used to combine results from included studies. A de novo Markov model was developed to assess the cost-effectiveness of the interventions.

RESULTS

Two Norwegian RCTs involving 201 participants were included. Eighty-eight per cent 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 [risk ratioâ =â 6.69; 95% confidence interval (CI) 1.57 to 28.51; pâ =â 0.01], in particular acute cholecystitis (risk ratioâ =â 9.55; 95% CI 1.25 to 73.27; pâ =â 0.03), and less likely to undergo surgery (risk ratioâ =â 0.50; 95% CI 0.34 to 0.73; pâ =â 0.0004), experience surgery-related complications (risk ratioâ =â 0.36; 95% CI 0.16 to 0.81; pâ =â 0.01) or, more specifically, minor surgery-related complications (risk ratioâ =â 0.11; 95% CI 0.02 to 0.56; pâ =â 0.008) than those randomised to surgery. Fifty-five per cent of people randomised to observation did not require an operation during the 14-year follow-up period and 12% of people randomised to cholecystectomy did not undergo the scheduled operation. The results of the economic evaluation suggest that, on average, the surgery strategy costs £1236 more per patient than the conservative management strategy but was, on average, more effective. An increase in the number of people requiring surgery while treated conservatively corresponded to a reduction in the cost-effectiveness of the conservative strategy. There was uncertainty around some of the parameters used in the economic model.

CONCLUSIONS

The results of this assessment indicate that cholecystectomy is still the treatment of choice for many symptomatic people. However, approximately half of the people in the observation group did not require surgery or suffer complications in the long term indicating that a conservative therapeutic approach may represent a valid alternative to surgery in this group of people. Owing to the dearth of current evidence in the UK setting a large, well-designed, multicentre trial is needed.

STUDY REGISTRATION

The study was registered as PROSPERO CRD42012002817.

FUNDING

The National Institute for Health Research Health Technology Assessment programme.

Abstract

BACKGROUND

Approximately 10-15% of the adult population suffer from gallstone disease, cholelithiasis, with more women than men being affected. Cholecystectomy is the treatment of choice for people who present with biliary pain or acute cholecystitis and evidence of gallstones. However, some people do not experience a recurrence after an initial episode of biliary pain or cholecystitis. As most of the current research focuses on the surgical management of the disease, less attention has been dedicated to the consequences of conservative management.

OBJECTIVES

To determine the clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management in people presenting with uncomplicated symptomatic gallstones (biliary pain) or cholecystitis.

DATA SOURCES

We searched all major electronic databases (e.g. MEDLINE, EMBASE, Science Citation Index, Bioscience Information Service, Cochrane Central Register of Controlled Trials) from 1980 to September 2012 and we contacted experts in the field.

REVIEW METHODS

Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies that enrolled people with symptomatic gallstone disease (pain attacks only and/or acute cholecystitis). Two reviewers independently extracted data and assessed the risk of bias of included studies. Standard meta-analysis techniques were used to combine results from included studies. A de novo Markov model was developed to assess the cost-effectiveness of the interventions.

RESULTS

Two Norwegian RCTs involving 201 participants were included. Eighty-eight per cent 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 [risk ratioâ =â 6.69; 95% confidence interval (CI) 1.57 to 28.51; pâ =â 0.01], in particular acute cholecystitis (risk ratioâ =â 9.55; 95% CI 1.25 to 73.27; pâ =â 0.03), and less likely to undergo surgery (risk ratioâ =â 0.50; 95% CI 0.34 to 0.73; pâ =â 0.0004), experience surgery-related complications (risk ratioâ =â 0.36; 95% CI 0.16 to 0.81; pâ =â 0.01) or, more specifically, minor surgery-related complications (risk ratioâ =â 0.11; 95% CI 0.02 to 0.56; pâ =â 0.008) than those randomised to surgery. Fifty-five per cent of people randomised to observation did not require an operation during the 14-year follow-up period and 12% of people randomised to cholecystectomy did not undergo the scheduled operation. The results of the economic evaluation suggest that, on average, the surgery strategy costs £1236 more per patient than the conservative management strategy but was, on average, more effective. An increase in the number of people requiring surgery while treated conservatively corresponded to a reduction in the cost-effectiveness of the conservative strategy. There was uncertainty around some of the parameters used in the economic model.

CONCLUSIONS

The results of this assessment indicate that cholecystectomy is still the treatment of choice for many symptomatic people. However, approximately half of the people in the observation group did not require surgery or suffer complications in the long term indicating that a conservative therapeutic approach may represent a valid alternative to surgery in this group of people. Owing to the dearth of current evidence in the UK setting a large, well-designed, multicentre trial is needed.

STUDY REGISTRATION

The study was registered as PROSPERO CRD42012002817.

FUNDING

The National Institute for Health Research Health Technology Assessment programme.

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