scholarly journals Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial

BMJ ◽  
2020 ◽  
pp. m1309 ◽  
Author(s):  
Joseph Shalhoub ◽  
Rebecca Lawton ◽  
Jemma Hudson ◽  
Christopher Baker ◽  
Andrew Bradbury ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Confidence Interval ◽  
Outcome Measures ◽  
Lower Limb ◽  
Primary Outcome ◽  
Elective Surgery ◽  
Compression Stockings ◽  
Graduated Compression Stockings ◽  
Randomised Controlled

AbstractObjectivesTo investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.DesignOpen, multicentre, randomised, controlled, non-inferiority trial.SettingSeven National Health Service tertiary hospitals in the United Kingdom.Participants1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.InterventionParticipants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.Outcome measuresThe primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.ResultsBetween May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval −0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.ConclusionsFor patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.Trial registrationISRCTN13911492.

scholarly journals Compression stockings in addition to low-molecular-weight heparin to prevent venous thromboembolism in surgical inpatients requiring pharmacoprophylaxis: the GAPS non-inferiority RCT

2020 ◽  
Vol 24 (69) ◽  
pp. 1-80
Author(s):  
Joseph Shalhoub ◽  
Rebecca Lawton ◽  
Jemma Hudson ◽  
Christopher Baker ◽  
Andrew Bradbury ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
High Risk ◽  
Low Molecular Weight Heparin ◽  
Low Dose ◽  
Low Molecular Weight ◽  
Compression Stockings ◽  
Vein Thrombosis ◽  
Graduated Compression Stockings ◽  
Deep Vein

Background Patients admitted to hospital for surgery are at an increased risk of venous thromboembolism. Pharmaco-thromboprophylaxis and mechanical prophylaxis (usually graduated compression stockings or intermittent pneumatic compression) have been shown to reduce the incidence of venous thromboembolism. The evidence base supporting the National Institute for Health and Care Excellence’s recommendation for the use of graduated compression stockings for venous thromboembolism prevention in the UK has recently been challenged. It is unclear if the risks and costs associated with graduated compression stockings are justified for deep-vein thrombosis prevention in moderate- and high-risk elective surgical inpatients receiving low-dose low-molecular-weight heparin pharmaco-thromboprophylaxis. Objectives The primary objective was to compare the venous thromboembolism rate in elective surgical inpatients at moderate or high risk of venous thromboembolism who were receiving either graduated compression stockings and low-dose low-molecular-weight heparin (standard care) or low-dose low-molecular-weight heparin alone (intervention). Design This was a pragmatic, multicentre, prospective, non-inferiority, randomised controlled trial. Setting This took place in secondary care NHS hospitals in the UK. Participants Patients aged ≥ 18 years who were assessed to be at moderate or high risk of venous thromboembolism according to the NHS England venous thromboembolism risk assessment tool (or the trust equivalent based on this form) and who were not contraindicated to low-molecular-weight heparin or graduated compression stockings were deemed eligible to take part. Interventions Participants were randomised 1 : 1 to either low-molecular-weight heparin or low-molecular-weight heparin and graduated compression stockings. Main outcome measures The primary outcome measure was venous thromboembolism up to 90 days after surgery. A combined end point of duplex ultrasound-proven new lower-limb deep-vein thrombosis (symptomatic or asymptomatic) plus imaging-confirmed symptomatic pulmonary embolism. Secondary outcomes included quality of life, compliance with graduated compression stockings and low-molecular-weight heparin during admission, and all-cause mortality. Results A total of 1905 participants were randomised and 1858 were included in the intention-to-treat analysis. A primary outcome event occurred in 16 out of 937 (1.7%) patients in the low-molecular-weight heparin-alone arm compared with 13 out of 921 (1.4%) patients in the low-molecular-weight heparin plus graduated compression stockings arm. The risk difference between low-molecular-weight heparin and low-molecular-weight heparin plus graduated compression stockings was 0.30% (95% confidence interval –0.65% to 1.26%). As the 95% confidence interval did not cross the non-inferiority margin of 3.5% (p < 0.001 for non-inferiority), the results indicate that non-inferiority of low-molecular-weight heparin alone was shown. Limitations In total, 13% of patients did not receive a duplex ultrasound scan that could have detected further asymptomatic deep-vein thrombosis. However, missing scans were balanced between both trial arms. The subpopulation of those aged ≥ 65 years assessed as being at a moderate risk of venous thromboembolism was under-represented in the study; however, this reflects that this group is under-represented in the general population. Conclusions For elective surgical patients at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings. These findings indicate that graduated compression stockings may be unnecessary for most elective surgical patients. Future work Further studies are required to evaluate whether or not adjuvant graduated compression stockings have a role in patients receiving extended thromboprophylaxis, beyond the period of hospital admission, following elective surgery or in patients undergoing emergency surgical procedures. Trial registration Current Controlled Trials ISRCTN13911492. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 69. See the NIHR Journals Library website for further project information.

scholarly journals Registration and publication of emergency and elective randomised controlled trials in surgery: a cohort study from trial registries

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021700 ◽  
Author(s):  
Rachael L Morley ◽  
Matthew J Edmondson ◽  
Ceri Rowlands ◽  
Jane M Blazeby ◽  
Robert J Hinchliffe
Keyword(s):  
Outcome Measures ◽  
Emergency Surgery ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Elective Surgery ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Surgical Trials ◽  
Surgical Interventions ◽  
Randomised Controlled

ObjectivesEmergency surgical practice constitutes 50% of the workload for surgeons, but there is a lack of high quality randomised controlled trials (RCTs) in emergency surgery. This study aims to establish the differences between the registration, completion and publication of emergency and elective surgical trials.DesignThe clinicaltrials.gov and ISRCTN.com trials registry databases were searched for RCTs between 12 July 2010 and 12 July 2012 using the keyword ‘surgery’. Publications were systematically searched for in Pubmed, MEDLINE and EMBASE.ParticipantsResults with no surgical interventions were excluded. The remaining results were manually categorised into ‘emergency’ or ‘elective’ and ‘surgical’ or ‘adjunct’ by two reviewers.Primary outcome measuresNumber of RCTs registered in emergency versus elective surgery.Secondary outcome measuresNumber of RCTs published in emergency versus elective surgery; reasons why trials remain unpublished; funding, sponsorship and impact of published articles; number of adjunct trials registered in emergency and elective surgery.Results2700 randomised trials were registered. 1173 trials were on a surgical population and of these, 414 trials were studying surgery. Only 9.4% (39/414) of surgical trials were in emergency surgery. The proportion of trials successfully published did not significantly differ between emergency and elective surgery (0.46 vs 0.52; mean difference (MD) −0.06, 95% CI −0.24 to 0.12). Unpublished emergency surgical trials were statistically equally likely to be terminated early compared with elective trials (0.33 vs 0.16; MD −0.18, 95% CI −0.06 to 0.41). Low accrual accounted for a similar majority in both groups (0.43 vs 0.46; MD −0.04, 95% CI −0.48 to 0.41). Unpublished trials in both groups were statistically equally likely to still be planning publication (0.52 vs 0.71; MD −0.18, 95% CI −0.43 to 0.07).ConclusionFewer RCTs are registered in emergency than elective surgery. Once trials are registered both groups are equally likely to be published.

scholarly journals Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)

2021 ◽  
pp. annrheumdis-2020-219091 ◽  
Author(s):  
Gary J Macfarlane ◽  
Marcus Beasley ◽  
Neil Scott ◽  
Huey Chong ◽  
Paul McNamee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Primary Outcome ◽  
Population Based ◽  
Behavioural Therapy ◽  
Short Course ◽  
Life Years ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveCognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.MethodsA population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.Results996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.ConclusionsA short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.Trial registration numberClinicalTrials.gov Registry (NCT02668003).

scholarly journals Systematic review on the benefit of graduated compression stockings in the prevention of venous thromboembolism in low-risk surgical patients

2020 ◽  
pp. 026835552095859
Author(s):  
M Machin ◽  
HC Younan ◽  
S Smith ◽  
Safa Salim ◽  
AH Davies ◽  
...  
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Included Study ◽  
Low Risk ◽  
Surgical Patients ◽  
Cochrane Library ◽  
Compression Stockings ◽  
Vte Prophylaxis ◽  
Eligible Article ◽  
Graduated Compression Stockings

Objectives The aim of this systematic review is to assess the performance of graduated compression stockings (GCS) in comparison to no venous thromboembolism (VTE) prophylaxis in the prevention of hospital-acquired thrombosis in low-risk surgical patients undergoing short-stay procedures. Methods Aligning with PRISMA guidelines, online databases MEDLINE and EMBASE, Cochrane Library® and trial registries were searched. Eligible articles reported the VTE rate in low-risk surgical patients either receiving GCS or no VTE prophylaxis. Results Narrative synthesis was performed on a single eligible article. The included study arm consisted of participants undergoing knee arthroscopy with the use of GCS alone reporting a total of 29 VTE events (4.4%), 16 of which were asymptomatic DVTs (2.4%). Conclusion There is a complete lack of evidence to support the use of GCS in the prevention of HAT for low-risk surgical patients. An adequately powered trial is required to provide level-IA evidence to support this practice.

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