Heparins and mechanical methods for thromboprophylaxis in ...

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Characteristics of included studies (Continued )Study Valle 1988MethodsParticipantsInterventionsOutcomesNotesAllocation concealmentRCT. Unclear randomizing procedure. Patient-, surgeon- and outcome-assessor blinded. No primary stratificationof colorectal patients.Elective general surgery patients. 100 randomized patients. Non excluded. Leaving 100 patiens in per protocolanalysis as well as in intention to treat analysis. Subgroup of 11 colorectal patients were distributed withrespectively 55 % and 45 % in the two arms.LMWH: 7500 anti-x-activated (highdose) preoperatively and x1 postoperatively for seven days.Control group: PlaceboThromboembolic events:DVTBleeding events: Not specified in colorectal patients.Diagnosis: Clinically and doppler sonography.Balanced distribution of colorectal patients.BStudy Wille-Jørgensen 1986MethodsParticipantsInterventionsOutcomesNotesAllocation concealmentRCT. Computergenerated list. Not blinded.Elective colorectal patients. 86 patients randomized. 5 excluded in LDH - and 3 excluded in LDH+TEDgroup. Leaving 78 patients in per protocol analysis.LDH: 5000 U unfractionated heparin preoperatively and x2 for seven days postoperatively.LDH+TED stockings: Same as above. Also stockings until ambulant.Tromboembolic events: DVT, PE and TEBleeding events: Not described.Diagnosis: Radiofibrinogen uptake test on 1,3, 5 and 7 th postoperative day. If positive then confirmed withphlebography.8 patients missing. No intention to treat analysis.AStudy Wille-Jørgensen 1991MethodsParticipantsInterventionsOutcomesNotesAllocation concealmentRCT. Sealed envelopes. Not consecutive. Not blinded. No primary stratification of colorectal patients.Acute abdominal patients. 276 randomized patients. 3 excluded in LDH arm, 15 excluded in LDH+TEDarm and 13 excluded in Dextran+TED arm. Leaving 244 patients in per protocol analysis. Subgroup of51 colorectal patients were distributed with respectively 31%, 33 % and 35% in the three treatment arms.Treatment arm with Dextran+TED were excluded from this analysis. Leaving 33 colorectal patients inanalysis.One arm with dextran is excluded from this analysis. Leaving 160 patients for this analysis. Of these 18 wereexcluded. Subgroup of 33 colorectal patients were distributed with respectively 49 % and 51 % in the tworemaining treatment arms.LDH: 5000 U unfractionated heparin preoperatively and x2 for seven days postoperatively.LDH+TED stockings: Same as above. Also stockings until ambulant.Tromboembolic events: TEBleeding events: Not specified in colorectal patients.Diagnosis: Radiofibrinogen uptake test on 1,3, 5 and 7 th postoperative day. If positive then confirmed withphlebography.18 patients missing. No intention to treat analysis.Balanced distribution of colorectal patients.AHeparins and mechanical methods for thromboprophylaxis in colorectal surgery (Review)Copyright © 2006 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd17
Characteristics of included studies (Continued )Characteristics of excluded studiesBounameaux 1993Browse 1974Comerota 1986 AEllis 1982Gallus 1993Kakkar 1993Mcleod 1995No author 1984Rasmussen 1988Strand 1975Torngren 1982Törngren 1980Colorectal patients not specified. Author contacted. Unable to help.Alternate leg. Not possible to include in meta-analysis.Colorectal patients not specified. Author contacted. Answered that it was not possible to recollect data. Datamore than 15 years old.Colorectal patients not specified. Author contacted. Answered that colorectal data was never specified.Colorectal patients not specified. Author contacted. Answered that it was not possible to recollect data.Double-publication.Possible that some of the patients in the abstract are reused in; Mcleod RS, Geerts WH, Sniderman K et al.Thromboprophylaxis after colorectal surgery - results of a randomized, double-blind comparison of low doseheparin and enoxaparin. Thrombosis and Haemostasis. juni, suppl. 1997:753 no PD3078.May contain patients from other studies.Not possible to identify colorectal patients.Fullfill all criteria but not valid diagnostic methods. Tc-plasmin test.The per protocol analysis operates with 102 surgical procedures in 100 patients. It is not possible to identify thepatient/patients which act as duplicatesHistorical controlgroup.Alternate leg. Not possible to include in meta-analysis.A N A L Y S E SComparison 01. Thromboembolic events (TE). LDH vs. no treatment.Outcome titleNo. ofstudiesNo. ofparticipants Statistical method Effect size01 DVT 4 145 Peto Odds Ratio 95% CI 0.30 [0.14, 0.67]02 PE, no studies 0 0 Peto Odds Ratio 95% CI Not estimable03 DVT and/or PE. Same as in“DVT”.0 0 Peto Odds Ratio 95% CI Not estimableComparison 02. Thromboembolic events (TE). LDH vs. placeboOutcome titleNo. ofstudiesNo. ofparticipants Statistical method Effect size01 DVT 3 114 Peto Odds Ratio 95% CI 0.55 [0.22, 1.36]02 PE 1 19 Peto Odds Ratio 95% CI 0.39 [0.05, 2.91]03 DVT and/or PE. 4 147 Peto Odds Ratio 95% CI 0.46 [0.21, 0.98]Comparison 03. Thromboembolic events (TE). LDH vs. no treatment or placeboOutcome titleNo. ofstudiesNo. ofparticipants Statistical method Effect size01 DVT 7 259 Peto Odds Ratio 95% CI 0.39 [0.22, 0.71]02 PE, same as LDH versus no 0 0 Peto Odds Ratio 95% CI Not estimabletreat/placeboHeparins and mechanical methods for thromboprophylaxis in colorectal surgery (Review)Copyright © 2006 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd18
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