Ahmad 2021.
Study characteristics | ||
Methods | Methods: single‐centre, prospective, randomised controlled, 2‐arm, parallel‐group, single‐blind (participants not blinded) Country: Egypt Duration: June 2019–December 2019 |
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Participants | Number randomised: 150 (75 in each arm) Number analysed: 150 (100%) Mean age: experimental group: 41.8 (SD 9.4) years; control group: 37.6 (SD 8.7) years Sex (male/female): 15/135 Comorbidities
Mean bodyweight: not reported Mean BMI: experimental group 46.4 (SD 8.7) kg/m2; control group: 45.2 (SD 5.2) kg/m2 Bariatric surgery techniques
Rationale for bariatric surgery indication: morbid obesity with repeated failure of weight loss after multidisciplinary medical treatment Inclusion criteria
Exclusion criteria
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Interventions | Experimental: mechanical thromboprophylaxis (perioperative elastic stockings on both lower limbs and early ambulation) combined with chemical thromboprophylaxis (enoxaparin 40 mg SC 12 hours preoperatively and every 24 hours postoperatively for 2 weeks) Control: mechanical thromboprophylaxis alone (perioperative elastic stockings on both lower limbs and early ambulation) Level of experience of the person carrying out the procedure: experienced Concomitant interventions: not reported Excluded medications: not reported |
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Outcomes | Primary (specified)
Primary (collected)
Secondary outcomes (specified)
Secondary outcomes (collected)
Time points reported: until 4 weeks after the procedure Cost of treatment: not reported |
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Funding source | Quote: "The authors received no financial support for the research, authorship, and/or publication of this article." | |
Declarations of interest of study authors | Quote: "The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article." | |
Notes | Protocol available (TCTR20200127002) Participants who experienced a VTE‐event were followed up for 6 months. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "An Excel sheet was used to create a randomization sequence with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor". |
Allocation concealment (selection bias) | Low risk | Quote: "A researcher who was not included with the clinical trial determined the allocation of treatment by sequentially opening numbered, opaque, sealed envelopes". |
Blinding of participants and personnel (performance bias) | Unclear risk | No method of blinding of participants or personnel was described. |
Blinding of outcome assessment (detection bias) | Low risk | Quote: "The same person [the researcher that did the randomisation] was also responsible after the assignment to the interventions". |
Incomplete outcome data (attrition bias) | Low risk | Quote: "No patient was withdrawn from the study after randomisation in addition to no changes to methods and outcomes after the commencement of the trial". |
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. |