A team from Sweden analyzed the outcomes after open small-incision surgery (mini-laparotomy) and laparoscopic surgery for gallstone disease, in general surgical practice.
Both elective and acute patients were eligible for inclusion in the randomized, single-blind trial.
All surgeons normally performing cholecystectomy (both trainees under supervision and consultants) operated on patients.
Laparoscopic cholecystectomy (LC) was a routine procedure at participating hospitals, whereas mini-laparotomy cholecystectomy (MC) was introduced after a short training period.
All non-randomized cholecystectomies at participating units, during the study period, were also recorded to analyze the external validity of trial results.
The randomization period was between March 1997 and April 1999.
A total of 1705 cholecystectomies were performed at participating units during the randomization period. Of these, 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.
| Operating time was longer, but convalescence was smoother, for LC.
| Annals of Surgery |
Surgeons who had done more than 25 operations of a particular type performed 264 operations in the LC group, and 150 operations in the MC group.
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 non-parametric test it was found to be significantly shorter after LC.
The researchers found that 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.
Dr Axel Ros, of the County Hospital of Ryhov, Jönköping, Sweden, concluded on behaf of fellow colleagues, "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."