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Prophylaxis of postoperative thromboembolism.Danish Medical Bullet<strong>in</strong> 1991;38:203–28.Wille-Jørgensen 1988Wille-Jørgensen P, Kjaergaard J, Jørgensen T, Korsgaard Larsen T.Failure <strong>in</strong> prophylactic management of thromboembolic disease <strong>in</strong>colorectal surgery. Dis Colon Rectum 1988;31:384–6. 1988211380.Wille-Jørgensen 1990Wille-Jorgensen P, Ott P. Predict<strong>in</strong>g failure of low.dose prophylactichepar<strong>in</strong> <strong>in</strong> general surgical patients. Surg Gynecol Obstet 1990;171:126–30.Wille-Jørgensen 1992Wille-Jørgensen P, Jørgensen LN, Hauch O, Borris LC, Lassen MR,Nehen AM, Kjær L, Jensen R. Potential <strong>in</strong>fluence of observer variationon thromboprophylactic studies. Hæmostasis 1992;22:211–5.∗ Indicates the major publication <strong>for</strong> the studyT A B L E SCharacteristics of <strong>in</strong>cluded studiesStudy Butson 1981MethodsParticipantsInterventionsOutcomesRCT. Sealed envelopes. Not bl<strong>in</strong>ded. (Controlgroup = no treatment). No primary stratification of colorectalpatients.Elective general surgery patients. 119 r<strong>and</strong>omized. Non excluded. Leav<strong>in</strong>g 119 patients <strong>in</strong> per protocolanalysis as well as <strong>in</strong> <strong>in</strong>tention to treat analysis. Subgroup of 24 colorectal patients were distributed withrespectively 63 % <strong>and</strong> 37 % <strong>in</strong> the two treatment arms.Intermittent compression: Intermittent compression peroperatively <strong>and</strong> untill ambulant. Most of the patients24 to 48 hours postoperatively.Control: No treatment.Thromboembolic events: DVTBleed<strong>in</strong>g events: Not described.Diagnosis: radiofibr<strong>in</strong>ogen uptake test every day up to 14 days postoperatively or untill discharge. If positivetest then confirmed with venography.<strong>Hepar<strong>in</strong>s</strong> <strong>and</strong> <strong>mechanical</strong> <strong>methods</strong> <strong>for</strong> <strong>thromboprophylaxis</strong> <strong>in</strong> colorectal surgery (Review)Copyright © 2006 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd11
Characteristics of <strong>in</strong>cluded studies (Cont<strong>in</strong>ued )NotesAllocation concealmentBoth <strong>in</strong>tention to treat- <strong>and</strong> per protocol analysis.Unbalanced distribution of colorectal patients.AStudy Covey 1975MethodsParticipantsInterventionsOutcomesNotesAllocation concealmentRCT. Coded vials. Patient-, surgeon- <strong>and</strong> outcome-assessor bl<strong>in</strong>ded. No primary stratification of colorectalpatients.Elective general surgery patients. 105 r<strong>and</strong>omized. Non excluded. Leav<strong>in</strong>g 105 patients <strong>in</strong> per protocolanalysis as well as <strong>in</strong> <strong>in</strong>tention to treat analysis. Subgroup of 20 colorectal patients were distributed withrespectively 45% <strong>and</strong> 55% <strong>in</strong> the two treatment arms.LDH: 5000 U unfractionated hepar<strong>in</strong> preoperatively <strong>and</strong> x2 postoperatively <strong>for</strong> 8 days or until discharge.Control group: PlaceboThromboembolic events: DVTBleed<strong>in</strong>g events: Not described.Diagnosis: radiofibr<strong>in</strong>ogen uptake test, until 8 th day.No miss<strong>in</strong>g patients.Balanced distribution of colorectal patients.BStudy Fricker 1988MethodsParticipantsInterventionsOutcomesNotesAllocation concealmentRCT. Unclear r<strong>and</strong>omiz<strong>in</strong>g procedure. Not bl<strong>in</strong>ded. No primary stratification of colorectal patients.Elective cancer general surgery. 80 r<strong>and</strong>omized patients. Non excluded. Leav<strong>in</strong>g 80 patients <strong>in</strong> per protocolanalysis as well as <strong>in</strong> <strong>in</strong>tention to treat analysis. Subgroup of 6 colorectal patients were distributed withrespectively 33% <strong>and</strong> 67% <strong>in</strong> the two treatment arms.LDH: 5000 IU unfractionated hepar<strong>in</strong> preoperatively <strong>and</strong> x3 postoperatively <strong>for</strong> ten days.LMWH: 2500 anti-Xa units (lowdose) preoperatively <strong>and</strong> 5000 anti-Xa units (mediumdose) x1 <strong>for</strong> ten dayspostoperatively.Thromboembolic events: PEBleed<strong>in</strong>g events: Not specified <strong>in</strong> colorectal patientsDiagnosis: Radiofibr<strong>in</strong>ogen uptake test. Positiv test confirmed by phlebography. PE: Cl<strong>in</strong>ically, confirmedby sc<strong>in</strong>tigraphy.Both <strong>in</strong>tention to treat- <strong>and</strong> per protocol analysis.Unbalanced distribution of colorectal patients.BStudy Gallus 1976MethodsParticipantsRCT. Sealed envelopes. Surgeon bl<strong>in</strong>ded. Not patient nor outcome-assessor bl<strong>in</strong>ded. (Controlgroup = notreatment).No primary stratification of colorectal patients.Elective general surgery patients. 820 r<strong>and</strong>omized patients. Non excluded. Leav<strong>in</strong>g 820 patients <strong>in</strong> perprotocol analysis as well as <strong>in</strong> <strong>in</strong>tention to treat analysis. Subgroup of 90 colorectal patients were distributedwith respectively 49 % <strong>and</strong> 51 % <strong>in</strong> the two treatment arms.Interventions LDH: 5000 units of unfractionated hepar<strong>in</strong> preoperatively <strong>and</strong> x3 postoperatively <strong>for</strong> seven days .Control: No treatmentOutcomesThromboembolic events: DVTBleed<strong>in</strong>g events: Not specified <strong>in</strong> colorectal patients.<strong>Hepar<strong>in</strong>s</strong> <strong>and</strong> <strong>mechanical</strong> <strong>methods</strong> <strong>for</strong> <strong>thromboprophylaxis</strong> <strong>in</strong> colorectal surgery (Review)Copyright © 2006 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd12