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Results. Results. P atients were operated on between January 1, 2001, and March 31, 2004. Initially, 366 patients fulfilled the inclusion criteria and agreed to be included in the trial. A total of 102 patients were not randomized for various reasons . 264 patients were randomly assigned

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results1
Results
  • Patients were operated on between January 1, 2001,and March 31, 2004.
  • Initially, 366 patients fulfilled the inclusioncriteria and agreed to be included in the trial.
  • A total of102 patients were not randomized for various reasons .
  • 264 patients were randomly assigned
  • 7 patientswere excluded due to:
    • unwillingness to participatefurther (2 patients)
    • intraoperative suspicion of malignantneoplasm (2 patients)
    • transfer to another ward not participatingin the trial (1 patient)
    • participation in 2 trials which is not inline with the Helsinki declaration (1 patient)
    • insufficientknowledge of the Dutch language (1 patient).
  • A total of 257patients were left for analysis .
baseline characteristics
Baseline Characteristics
  • The 2 groups did not differ with regard to age, sex, body massindex, and ASA classification.
  • Patients were evaluated on thefollowing classic diagnostic symptoms of cholecystolithiasisin both groups:
    • severe pain, episodic pain, epigastric pain,pain in the right upper quadrant, pain radiating to the back,pain lasting 1 to 5 hours, awakening at night, and Murphy’ssign.
  • There were no significant differences in the presenceand the duration of these symptoms.
  • The numbers of patientspresenting with complicated gallstone disease and operated onin a later stage also were equally distributed.
  • Pre-op blood analysis consisting of ESR, WBC count, and levels of CRP, alanineaminotransferase, aspartateaminotransferase, -glutamyltransferase,alkaline phosphatase, and bilirubin showed no significant differencesbetween groups.
operative results
Operative Results
  • Among intraoperative factors, more adhesions (2 = 9.15,P = .002) and intraoperativebile leakage (by gallbladderperforation) (2 = 10.26, P = .001) were found in theLC group.
  • Skin was left open for secondarywound healing more often in the LC group (2 = 31.69,P < .001).
  • Intraoperative stone loss, presenceof inflammation, and identification of the cystic duct and thecommon bile duct were not statistically different between the2 groups.
  • The cystic artery (P = .005) and Calot triangle(P < .001) were identified more frequently in theLC group.
  • SIC group a combined ligation of the cysticduct and artery was performed more frequently (P < .001).
slide7

Surgical residents performed 105 LCs (87.5%) and 118 SICs (86.1%).

  • Operative time was shorter for SIC (60 vs 72 minutes; U = 6013.0;P < .001).
  • Conversion rates were similar,with similar distribution of reasons for conversion.
  • Total incision length of scars, measured in 229 patients, appearedto be not statistically different between the LC and SIC groups.
complications
Complications
  • There were no deaths in the trial.
  • There were 5 intraoperativecomplications in the LC group and 3 in the SIC group.
  • 1 common bile duct injury occurred in eachgroup (treated by T-drainage and hepaticojejunostomy).
  • No significatnt difference in complications between the two groups.
postoperative complaints
POSTOPERATIVE COMPLAINTS
  • Follow-up rate between the groups was not statisticallydifferent.
  • Follow-up in the LC and SIC groups
    • @ 6 weeks 88.3% and 94.9%
    • @ 3 month 80.0% and 81.0%
    • all patients showed up at either their 6-week or their 3-monthfollow-up appointment.
    • All patients who did not show up at their2-week or 6-week follow-up appointment appeared not to haveany problems at their next scheduled follow-up appointment.
  • 9.2% and 10.2% of patientsin the LC and SIC groups experienced failureof symptom relief.
postoperative complaints1
POSTOPERATIVE COMPLAINTS
  • Postoperative complaints at follow-up:
    • Dietary complaints (26 vs 30 patients ; P = .96)
    • Diarrhea(17 vs 15; P = .44),
    • Fatigue (13 vs 6; P = .049),
    • Complaints suggestive of presence of common bile duct stones(6 vs 9; P = .59). T
  • No statistical differencein the number of patients undergoing endoscopic retrograde cholangiopancreatographyor magnetic resonance cholangiopancreaticography postoperatively(2 vs 5; P = .24).