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Results

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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Results

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  1. Results

  2. 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 .

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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).

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