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Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy: a prospective, randomized, single-blind study
Department of Surgery, County Hospital of Ryhov, Jönköping, Sweden.
Motala Hospital, Motala, Sweden.
Vrinnevi Hospital, Norrköping, Sweden.
County Hospital, Kalmar, Sweden.
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2001 (English)In: Annals of Surgery, ISSN 0003-4932, E-ISSN 1528-1140, Vol. 234, no 6, 741-749 p.Article in journal (Refereed) Published
Abstract [en]

Objective: To analyze outcomes after open small-incision surgery (minilaparotomy) and laparoscopic surgery for gallstone disease in general surgical practice.

Methods: This study was a randomized, single-blind, multicenter trial comparing laparoscopic cholecystectomy (LC) to minilaparotomy cholecystectomy (MC). Both elective and acute patients were eligible for inclusion. All surgeons normally performing cholecystectomy, both trainees under supervision and consultants, operated on randomized patients. LC was a routine procedure at participating hospitals, whereas MC was introduced after a short training period. All nonrandomized cholecystectomies at participating units during the study period were also recorded to analyze the external validity of trial results. The randomization period was from March 1, 1997, to April 30, 1999.

Results: Of 1,705 cholecystectomies performed at participating units during the randomization period, 724 entered the trial and 362 patients were randomized to each of the procedures. The groups were well matched for age and sex, but there were fewer acute operations in the LC group than the MC group. In the LC group 264 and in the MC group 150 operations were performed by surgeons who had done more than 25 operations of that type. Median operating times were 100 and 85 minutes for LC and MC, respectively. Median hospital stay was 2 days in each group, but in a nonparametric test it was significantly shorter after LC. Median sick leave and time for return to normal recreational activities were shorter after LC than MC. Intraoperative complications were less frequent in the MC group, but there was no difference in the postoperative complication rate between the groups. There was one serious bile duct injury in each group, but no deaths.

Conclusions: Operating time was longer and convalescence was smoother for LC compared with MC. Further analyses of LC versus MC are necessary regarding surgical training, surgical outcome, and health economy.

Place, publisher, year, edition, pages
2001. Vol. 234, no 6, 741-749 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-82122DOI: 10.1097/00000658-200112000-00005PubMedID: 11729380OAI: diva2:557991
Available from: 2012-10-01 Created: 2012-10-01 Last updated: 2012-10-01Bibliographically 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.
Linköping University Medical Dissertations, ISSN 0345-0082 ; 921
National Category
Medical and Health Sciences
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)
Available from: 2009-10-09 Created: 2009-10-09 Last updated: 2012-10-01Bibliographically approved

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