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. 2022 Nov 22;2022(11):CD013683. doi: 10.1002/14651858.CD013683.pub2

Steib 2016.

Study characteristics
Methods Methods: multicentre, prospective, randomised controlled, 3‐arm, parallel‐group, double‐blind
Country: France
Duration: July 2010–August 2013
Participants Number randomised: 164; experimental group: 56; control group 1: 54; control group 2: 54
Number analysed: 148 (90.2%); experimental group: 53; control group 1: 47; control group 2: 48
Mean age: experimental group: 39.5 (SD 1.7) years; control group 1: 40 (SD 1.5) years; control group 2: 39 (SD 1.5) years
Sex (male/female): 29/107
Comorbidities

  • Hypertension: 19 participants in experimental group; 20 participants in control group 1; 19 participants in control group 2

  • Diabetes: 13 participants in experimental group; 6 participants in control group 1; 13 participants in control group 2

  • Dyslipidaemia: 6 participants in experimental group; 7 participants in control group 1; 2 participants in control group 2


Mean bodyweight: not reported
Mean BMI: experimental group: 47 (SD 1) kg/m2; control group 1: 48 (SD 1) kg/m2; control group 2: 49 (SD 1) kg/m2
Bariatric surgery techniques

  • LYRB (100%)


Rationale for bariatric surgery indication: BMI ≥ 40 kg/m2
Inclusion criteria

  • Age > 18 years

  • BMI ≥ 40 kg/m2

  • Scheduled LRYB

  • Either sex


Exclusion criteria

  • Pregnancy

  • History of allergy to heparin

  • Chronic treatment with VKAs or antiplatelet agents

  • Renal impairment (clearance < 60 mL/min/m2)
Interventions Experimental: enoxaparin 4000 IU bid
Control 1: enoxaparin 6000 IU once daily
Control 2: enoxaparin 4000 IU once daily
Level of experience of the person carrying out the procedure: not reported
Concomitant interventions

  • Sequential compression devices or stockings during surgery: all participants

  • 4000 UI enoxaparin at 18:00 the day before surgery: all participants

  • Ambulation on the evening of surgery, where possible


Excluded medications: NSAIDs
Outcomes Primary (specified)

  • Anti‐Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 hours)


Primary (collected)

  • Anti‐Xa activity level


Secondary (specified)

  • Microparticles (day 0, 1, 9, 30)

  • Thrombotic events (until day 30)

  • Bleeding events (day 30)


Secondary (collected)

  • Microparticles (day 0, 1, 9, 30)

  • Thrombotic events (until day 30)

  • Bleeding events (day 30)


Time points reported: until 30 days after the procedure
Cost of treatment: not reported
Funding source Quote: "This work was sponsored two thirds by institutional grants (Program of Interregional Research) and one third by industrial grants (Sanofi‐Aventis). Funding was managed by the Research Department of Strasbourg University Hospital."
Quote: "Financial supporters had no role in the design and conduct of the study, in the collection and analysis of the data, or in the preparation of the manuscript."
Declarations of interest of study authors Quote: "The authors have no commercial associations that might be a conflict of interest in relation to this article."
Notes Protocol available (NCT00444652)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Incomplete information.
Quote: "patients were randomly assigned to groups".
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias) High risk Open‐label study (protocol information).
Blinding of outcome assessment (detection bias) High risk Open‐label study (protocol information).
Incomplete outcome data (attrition bias) Low risk 16 participants were not treated according to protocol (9%), but the reasons were reported, and the losses were balanced between the groups.
Quote: "One patient refused to participate to the study before treatment, 15 patients were not treated for logistic reasons (4 cancellations of surgery, 6 absences of investigators, 4 preoperative deviations from protocol, and 1 gaseous embolism)".
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported.
Other bias Low risk We do not suspect any other bias related to this study.

bid: twice daily; BMI: body mass index; DBP: diastolic blood pressure; DM: diabetes mellitus; DVT: deep vein thrombosis; GORD: gastro‐oesophageal reflux disease; HIT: heparin‐induced thrombocytopenia; IU: international unit; LMWH: low‐molecular‐weight heparin; LRYB: laparoscopic Roux‐en‐Y gastric bypass; MRV: magnetic resonance venography; NSAIDs: non‐steroidal anti‐inflammatory drugs; OCP: oral contraceptive pill; PE: pulmonary embolism; RYB: Roux‐en‐Y gastric bypass; SBP: systolic blood pressure; SC: subcutaneously; SD: standard deviation; tid: three times daily; UFH: unfractionated heparin; VKA: vitamin‐K antagonist; VTE: venous thromboembolism.