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Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes
Department of Surgery, County Hospital of Ryhov, Jönköping, Sweden .
Linköping University, Department of Department of Health and Society, Center for Medical Technology Assessment. Linköping University, Faculty of Health Sciences.
Linköping University, Department of Department of Health and Society, Center for Medical Technology Assessment. Linköping University, Faculty of Health Sciences.
Linköping University, Department of Department of Health and Society, Center for Medical Technology Assessment. Linköping University, Faculty of Health Sciences.ORCID iD: 0000-0002-9212-7476
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2006 (English)In: BMC Surgery, ISSN 1471-2482, E-ISSN 1471-2482, Vol. 6, no 17Article in journal (Refereed) Published
Abstract [en]

  Background

Laparoscopic cholecystectomy is now considered the first option for gallbladder surgery. However, 20% to 30% of cholecystectomies are completed as open operations often on elderly and fragile patients. The external validity of randomised trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy has not been studied. The aim of this study is to analyse characteristics, procedures, and outcomes for all patients who underwent cholecystectomy without being included in such a trial.

Methods

Characteristics (age, sex, co-morbidity, and ASA-score), operation time, hospital stay, and mortality were compared for patients who underwent cholecystectomy outside and within a randomised controlled trial comparing mini-laparotomy and laparoscopic cholecystectomy.

Results

During the inclusion period 1719 patients underwent cholecystectomy. 726 patients were randomised and 724 of them completed the trial; 993 patients underwent cholecystectomy outside the trial. The non-randomised patients were older – and had more complications from gallstone disease, higher co-morbidity, and higher ASA – score when compared with trial patients. They were also more likely to undergo acute surgery and they had a longer postoperative hospital stay, with a median 3 versus 2 days (p < 0.001 for all comparisons). Standardised mortality ratio within 90 days of operation was 3.42 (mean) (95% CI 2.17 to 5.13) for non-randomised patients and 1.61 (mean) (95%CI 0.02 to 3.46) for trial patients. For non-randomised patients, operation time did not differ significantly between mini-laparotomy and open cholecystectomy in multivariate analysis. However, the operation for laparoscopic cholecystectomy lasted 20 minutes longer than open cholecystectomy. Hospital stay was significantly shorter for both mini-laparotomy and laparoscopic cholecystectomy compared to open cholecystectomy.

Conclusion

Non-randomised patients were older and more sick than trial patients. The assignment of healthier patients to trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy limits the external validity of conclusions reached in such trials.

Place, publisher, year, edition, pages
2006. Vol. 6, no 17
Keyword [en]
External validity, Randomised controlled trial, Cholecystectomy
National Category
Social Sciences
Identifiers
URN: urn:nbn:se:liu:diva-37112DOI: 10.1186/1471-2482-6-17Local ID: 33729OAI: oai:DiVA.org:liu-37112DiVA: diva2:257961
Available from: 2009-10-10 Created: 2009-10-10 Last updated: 2017-12-13Bibliographically approved
In thesis
1. Cholecystectomy: studies on surgical methods, incidence and economy
Open this publication in new window or tab >>Cholecystectomy: studies on surgical methods, incidence and economy
2005 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

After almost a century without change in the surgical care of gallstone disease since the first cholecystectomy in 1882, a profound change in surgical treatment of gallstones has taken place over the last three decades with the introduction of endoscopic sphincterotomy for treatment of bile duct stones (EST), minilaparotomy cholecystectomy (MC), and laparoscopic cholecystectomy (LC). The epidemiology of gallstone surgery has changed since these minimally invasive procedures were introduced. This thesis is based on studies on surgical methods, incidence and outcome in cholecystectomy.

Paper I. Changes in the surgical treatment of gallstones from the 1970's to the 1990's in the town of Jönköping, with a population of about 110.000, was studied. During these years EST, MC and LC was introduced as alternatives to conventional cholecystectomy (OC) in gallstone treatment. The development of different strategies for gallstone treatment has given the surgeon the possibility to plan each patient's treatment individually. Hospital stay after treatment decreased, but post-operative morbidity and mortality did not decrease. The cholecystectomy rate decreased from the 1970's to the 1980's, but was then stable up to the 1990's. However there was an increase in cholecystectomy rate in the 1990's amongst women. The proportion of urgent surgery increased over the whole period.

Paper II. All cholecystectomies in Sweden in the years 1987-1995 was studied in a retrospective study based on information from the Swedish Hospital Discharge Register with special reference to outcomes measured as re-admissions with re-interventions and mortality. Simple cholecystectomy was defined as a cholecystectomy without bile duct exploration. LC was rapidly introduced in 1991-1992. Over the period studied there was an increase in total cholecystectomy rate and in the proportion of simple cholecystectomies. There was an increase in re-admission with endoscopic or percutaneous re-intervention after cholecystectomy in Sweden between 1987 and 1995. During the same period re-admissions with re-operations on the bile ducts first decreased and then increased after 1991. There was a higher risk for re-admission with endoscopic or percutaneous re-intervention after simple LC than simple OC. Mortality was higher after simple cholecystectomies completed as OC than after simple LC.

Papers III-VI. A prospective, randomised, single-blind, multicenter study on LC versus MC was performed. In order to examine the external validity of the randomised trial, also all non-randomised patients undergoing cholecystectomy at participating departments were prospectively registered. During the study period 1719 cholecystectomies were scheduled, of those 724 patients entered and fulfilled the randomised study. Based on the results from the trial the following was concluded. Operating time is shorter for MC than LC. Postoperative recovery (pain, hospital stay, sick-leave, time back to normal activities) is shorter after LC than MC. Differences are small but significant. There is no difference in postoperative complication rate after LC and MC. Differences in health-related quality of life between LC and MC are small and of short duration. Health-care costs are higher for LC than MC. Taking the cost of sick-leave into account there are no differences in costs between LC and MC. Health economy does not include costs for surgical training. At long-term follow-up, no differences are seen regarding abdominal pain, patient satisfaction with surgery scar(s) and overall patient satisfaction after LC and MC. A large proportion of patients have abdominal pain after cholecystectomy. Patients not included in the randomised trial were older and more ill, had a higher chance of undergoing conventional open surgery and urgent surgery, and were found to have a higher mortality than included patients. The assignment of healthier patients to studies comparing MC and LC limits the external validity of conclusions reached in such trials.

Place, publisher, year, edition, pages
Linköping: Linköpings universitet, 2005. 74 p.
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 921
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-31177 (URN)16917 (Local ID)91-85299-30-8 (ISBN)16917 (Archive number)16917 (OAI)
Public defence
2005-11-25, Föreläsningssalen Originalet, Qulturum, Länssjukhuset Ryhov, Jönköping, 13:00 (Swedish)
Opponent
Available from: 2009-10-09 Created: 2009-10-09 Last updated: 2012-10-01Bibliographically approved

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Carlsson, PerRahmqvist, MikaelBäckman, Karin

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