|
NEW Vascular Surgery COCHRANE REVIEWS
From The Cochrane Library
Free for all New Zealanders at:
www.thecochranelibrary.com
[use » as hyperlink to abstract]
[Click on url link for full text of review]
Latest update Issue 4 2009
The New Zealand Branch of the Australasian Cochrane Centre Presents the New
Vascular Surgery Cochrane Reviews From
The Cochrane Library, Issue 4, 2008
Free for all New Zealanders at:
www.thecochranelibrary.com
[Click on the title to hyperlink to abstract]
- Beta blockers for peripheral arterial disease
- Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism in high-risk patients
- Low molecular weight heparin for prevention of venous thromboembolism in patients with lower-leg immobilization
To view the reviews in full please follow the link provided at the end of each of these abstracts
Beta blockers for peripheral arterial disease
Sharath Chandra Vikram Paravastu2, Derick Mendonca3, Anthony Da Silva1
Abstract
Background
Beta (ß) blockers are indicated for use in coronary artery disease (CAD). However, optimal therapy for people with CAD accompanied by intermittent claudication has been controversial due to the presumed peripheral haemodynamic consequences of beta blockers, leading to worsening symptoms of intermittent claudication.
Objectives
To quantify the potential harm of beta blockers on maximum walking distance, claudication distance, calf blood flow, calf vascular resistance, and skin temperature when used in patients with peripheral arterial disease (PAD).
Search strategy
The Cochrane Peripheral Vascular Diseases (PVD) Group searched for publications describing randomised controlled trials (RCTs) of beta blockers in PAD in their Trials Register (last searched 6 May 2008) and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched The Cochrane Library 2008, Issue 2). We handsearched relevant journals and conference proceedings.
Selection criteria
Randomised controlled trials evaluating the role of both selective (ß1) and non-selective (ß1 and ß2) beta blockers compared with placebo. We excluded trials comparing different types of beta blockers.
Data collection and analysis
Primary outcome measures were claudication distance in metres, and the time to claudication in minutes, and maximum walking distance in metres and minutes (as assessed by treadmill).
Secondary outcome measures were calf blood flow (ml/100 ml/min), calf vascular resistance, and skin temperature (ºC).
Main results
We included six RCTs fulfilling the above criteria, with a total of 119 patients. The beta blockers studied were atenolol, propranolol, pindolol, and metoprolol. None of the trials showed a statistically significant worsening effect of beta blockers on either the primary or secondary outcomes. There were no reports of any adverse events with the beta blockers studied.
Authors' conclusions
There is currently no evidence that beta blockers adversely affect walking distance in people with intermittent claudication. However, due to the lack of large published trials beta blockers should be used with caution if clinically indicated.
Plain language summary
Beta blockers for peripheral arterial disease
Intermittent claudication is the most common symptom of atherosclerotic peripheral arterial disease and results from decreased blood flow to the legs during exercise. Beta blockers are a large group of drugs that have been shown to decrease deaths in people with high blood pressure and coronary artery disease and are used to treat a number of disorders. They reduce heart activity but can also inhibit relaxation of smooth muscle in blood vessels, bronchi, and the gastrointestinal and genitourinary tracts.
The non-selective beta blockers propranolol, timolol and pindolol are effective at all beta-adrenergic sites in the body whereas some beta blockers are selective for the heart, such as atenolol and metoprolol.
Optimal therapy for people with either coronary artery disease or hypertension and intermittent claudication is controversial. This is because of the presumed peripheral blood flow consequences of beta blockers, leading to worsening of symptoms.
There is currently no evidence from randomised controlled trials that beta blockers adversely affect walking distance in people with intermittent claudication and beta blockers should be used with caution if clinically indicated. The review authors identified six randomised controlled trials that involved a total of only 119 people with mild to moderate peripheral arterial disease. The beta blockers studied were propranolol, pindolol, atenolol and metoprolol. None of the trials showed a clear worsening effect of beta blockers on time to claudication, claudication and maximal walking distances measured on a treadmill, calf blood flow, calf vascular resistance and skin temperature when compared with placebo. The trials did not report any adverse events or issues regarding taking the medication with the beta blockers studied.
Most of the trials were over 10 years old, reported on between 1980 and 1991. All were small and of poor quality. The drugs were administered for a short period of time (10 days to two months) and most of the outcome measures were reported in single studies. Additional drugs, calcium channel blockers and combined alpha and beta blockers, were also given in some of the trials.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD005508/frame.html
Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism in high-risk patients
Stavros K Kakkos1, Joseph A Caprini2, George Geroulakos3, Andrew N Nicolaides4, Gerard P Stansby5, Daniel J Reddy1
Abstract
Background
It has been suggested that combined modalities (methods of treatment) are more effective than single modalities in preventing venous thromboembolism (defined as deep vein thrombosis and pulmonary embolism, or both) in high-risk patients.
Objectives
To assess the efficacy of intermittent pneumatic leg compression combined with pharmacological prophylaxis versus single modalities in preventing venous thromboembolism in high-risk patients.
Search strategy
The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialized Register (last searched 17 July 2007) and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched The Cochrane Library 2008, Issue 3). We searched the reference lists of relevant articles to identify additional trials.
Selection criteria
Randomized controlled trials (RCTs) or controlled clinical trials (CCTs) of combined intermittent pneumatic leg compression and pharmacological interventions used to prevent venous thromboembolism in high-risk patients.
Data collection and analysis
Data extraction was undertaken independently by two review authors using data extraction sheets.
Main results
Eleven studies, six of them randomized controlled trials, were identified. The trials included 7431 patients, in total. Compared with compression alone, the use of combined modalities reduced significantly the incidence of both symptomatic pulmonary embolism (PE) (from about 3% to 1%; odds ratio (OR) 0.39, 95% confidence interval (CI) 0.25 to 0.63) and deep vein thrombosis (DVT) (from about 4% to 1%; OR 0.43, 95% CI 0.24 to 0.76). Compared with pharmacological prophylaxis alone, the use of combined modalities significantly reduced the incidence of DVT (from 4.21% to 0.65%; OR 0.16, 95% CI 0.07 to 0.34) but the included studies were underpowered with regard to PE. The comparison of compression plus pharmacological prophylaxis versus compression plus aspirin showed a non-significant reduction in PE and DVT in favor of the former group. Repeat analysis restricted to the RCTs confirmed the above findings.
Authors' conclusions
Compared with compression alone, combined prophylactic modalities decrease significantly the incidence of venous thromboembolism. Compared with pharmacological prophylaxis alone, combined modalities reduce significantly the incidence of DVT but the effect on PE is unknown. The results of the current review support, especially in high-risk patients, the use of combined modalities. More studies on their role in PE prevention, compared with pharmacological prophylaxis alone, are urgently needed.
Plain language summary
Combined intermittent pneumatic leg compression and medication for the prevention of deep vein thrombosis and pulmonary embolism in high-risk patients
Deep vein thrombosis (DVT) and pulmonary embolism, or venous thromboembolism, are possible complications of surgery and trauma. These complications extend hospital stay and are associated with long-term disability and death. Patients undergoing total hip or knee replacement surgery or surgery for colorectal cancer are at high risk of venous thromboembolism. Sluggish venous blood flow, increased blood clotting and blood vessel endothelial injury are contributing factors. Treating more than one of these causes may improve prevention. Mechanical intermittent pneumatic leg compression reduces venous stasis while medications such as aspirin and anticoagulants such as low molecular weight heparin reduce blood clotting. The medications can also increase the risk of bleeding.
The present review showed that combining the two methods was more effective than a single preventative measure. Compared to compression alone, compression plus anticoagulant (combined prophylactic modalities) clearly decreased the incidence of both symptomatic pulmonary embolism (from 2.7% to 1.1%) and DVT (from 4% to 1.6%). Compared with medication with anticoagulants alone, combined compression and medication clearly reduced the incidence of DVT (from 4.21% to 0.65%). The effect on pulmonary embolism could not be determined because of the lack of events in the included
studies.
These conclusions are based on 11 controlled trials involving a total of 7431 surgery patients. The mean age of patients, where reported, was 65.5 years. Most patients had either a high-risk procedure or condition. The surgical procedures were orthopedic surgery in six trials and urological, cardiothoracic, general surgery and gynecology procedures in the other trials. The magnitude of the reduction in venous thromboembolism may be less for patients at moderate risk.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD005258/frame.html
Low molecular weight heparin for prevention of venous thromboembolism in patients with lower-leg immobilization
Mark Testroote1, Willem Stigter1, Dianne C de Visser2, Heinrich Janzing1
Abstract
Background
Immobilization of the lower leg is associated with venous thromboembolism. Low molecular weight heparin (LMWH) is an anticoagulant treatment which might be used in adult patients with lower-leg immobilization to prevent deep venous thrombosis and its complications.
Objectives
To investigate the current literature on thromboprophylactic practice for patients with lower-limb injuries who are immobilized in plaster casts or braces, to assess the need for concrete guidelines, and to assess whether it is possible to come to an evidence-based conclusion.
Search strategy
The Cochrane Peripheral Vascular Disease Group searched their Specialized Register (last searched 20 May 2008) and the Central Register of Controlled Trials (CENTRAL) (last searched The Cochrane Library 2008, Issue 2). We searched MEDLINE (until May 2008) and EMBASE (until May 2008) and reference lists of articles. We contacted pharmaceutical companies of LMWHs for relevant studies.
Selection criteria
Randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that described thromboprophylaxis by means of LMWH compared with no prophylaxis or placebo in adult patients with lower-leg immobilization. Immobilization was by means of a plaster cast or brace.
Data collection and analysis
Two authors independently assessed trial quality and extracted data. The review authors contacted the trial authors for additional information if required. Statistical analysis was carried out using Review Manager (RevMan 5).
Main results
We included six RCTs fulfilling the above criteria with a total of 1490 patients. We found an incidence of venous thromboembolism ranging from 4.3% to 40%, in patients who had a leg injury that had been immobilized in a plaster cast or a brace for at least one week and who received no prophylaxis, or placebo. This number was significantly lower in patients who received daily subcutaneous injections of LMWH during immobilization (event rates ranging from 0% to 37%; odds ratio (OR) 0.49; fixed 95% confidence interval (CI) 0.34 to 0.72; with minimal evidence of heterogeneity with an I2 of 20%, P = 0. 29). Comparable results were seen in the following subcategories: operated patients, conservatively treated patients, patients with fractures, patients with soft-tissue injuries, patients with proximal thrombosis, patients with distal thrombosis and patients with below-knee casts. Complications of major bleeding events were extremely rare (0.3%) and there were no reports of heparin-induced thrombocytopenia.
Authors' conclusions
Use of LMWH in outpatients significantly reduces VTE when immobilization of the lower leg is required.
Plain language summary
Low molecular weight heparin for prevention of venous thromboembolism in adults with lower-leg immobilization in an outpatient setting
Immobilization of the lower limb with plaster cast or brace in adult patients is associated with deep venous thrombosis (DVT). In order to prevent this complication preventativec treatment with anticoagulants is often used, most commonly low molecular weight heparin (LMWH). Different indications for the use of LMWH are given in existing national guidelines. Therefore we searched the literature for trials on this topic, in order to develop an evidence-based stand on this matter.
Six randomized controlled trials were found and judged to be of sufficient quality to use in a meta-analysis. The trials involved 1490 patients: 750 patients received LMWH subcutaneously once daily; 740 patients received no prophylaxis or placebo. Incidence rates of DVT ranging from 4.3% to 40% were found in the control groups and ranging from 0% to 37% in the LMWH groups. There was a significant difference (odds ratio 0.49, 95% confidence interval = 0.34 to 0.72). Further analysis showed a significant reduction of the occurrence of DVT when using LMWH in the following subgroups: operated patients; conservatively treated patients; patients with fractures; patients with soft-tissue injuries; patients with below-knee casts; a group with proximal thrombosis and a group with distal thrombosis.
There were few reported adverse effects in the treated patients. Two patients in the treatment group and one in the placebo group had to discontinue the LMWH due to major bleeding events. In the treatment group minor bleeding events were reported in up to 8% of cases. One patient developed facial eczema.
We conclude that LMWH should be used in adult patients with immobilization of the lower leg to prevent occurrence of venous thromboembolism. It should not only be used in patients with an above-knee cast but also in patients with a below-knee cast. LMWH can safely be used for this indication.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006681/frame.html
For further information about any of the above please feel free to contact
Dr Vanessa Jordan PhD
New Zealand Cochrane Fellow
New Zealand Branch of the Australasian Cochrane Centre
Department of Obstetrics and Gynaecology
Auckland University
e-mail: v.jordan@auckland.ac.nz
Ph: 09 373 7599 ext 89490
Issue 2 2009 features review of angioplasty versus stenting in the superficial femoral artery and the use of Ginkgo biloba for claudication
Issue 4 2008 covers beta blockers in peripheral arterial disease, combined intermittent pneumatic leg compression and pharmacological prophylaxis of DVT in high risk patients, and low molecular weight heparin DVT prohylaxis in patients with lower limb immobilisation.
Issue 2 2008 covers Naftidrofuryl for intermittent claudication and oral vasodilators for primary Raynaud's phenomenon
Issue 1 2008
- Interventions for preventing venous thromboembolism following abdominal aortic surgery >>
- Ischaemic preconditioning for liver transplantation >>
- Surgical hand antisepsis to reduce surgical site infection >>
- Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults >>
Issue 4 2007
- Cryoplasty for peripheral vascular disease >>
- Methods of vascular occlusion for elective liver resections >>
- Single dose oral lumiracoxib for postoperative pain >>
- Use of plastic adhesive drapes during surgery for preventing surgical site infection >>
Interventions for preventing venous thromboembolism following abdominal aortic surgery
MG Bani-Hani, H Al-Khaffaf, MA Titi, I Jaradat
Abstract
Background
Deep vein thrombosis (DVT) is one of the most common, preventable complications of surgery. Although the relationship between surgery and DVT is well established in general surgical operations and most other subspecialties, the same cannot be said about arterial surgery. Deep vein thrombosis is believed to be less common in aortic surgery where its management is rather controversial with a reported incidence of DVT from 2% to 18%.
Intra-operative heparin is believed to provide protection during the period when DVT is most likely to develop. However, the practice of using intra-operative heparin could increase the risk of haemorrhagic complications if further heparin is used during the recovery period. This can significantly limit the use of such prophylactic measures especially with the low perceived risk of venous thromboembolism (DVT or pulmonary embolism (PE)) following abdominal aortic surgery. However, vascular patients are usually older, with more co-morbidity and are subject to prolonged immobility, all of which increase the likelihood of developing venous thromboembolism.
Objectives
To determine the efficacy of anticoagulant prophylaxis (with or without mechanical devices) in patients undergoing surgery for abdominal aortic aneurysm.
Search strategy
The Cochrane Peripheral Vascular Diseases Group searched their trials register (last searched 8 August 2007) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, (last searched Issue 3, 2007).
The authors searched for additional trials through reference lists of retrieved studies and conference proceedings.
Selection criteria
Randomised controlled trials comparing the use of anticoagulants (with or without mechanical devices) with control or no intervention in preventing DVT or PE after abdominal aortic operations.
Data collection and analysis
Three authors independently selected potential trials and assessed trial quality.
Main results
Two studies (n=147) were included. Both studies had methodological limitations.
There were no data to indicate that post operative anticoagulation, with or without the use of mechanical devices, can safely reduce the incidence of DVT after aortic surgery. Neither study reported a significant effect of anticoagulants on the incidence of PE or related mortality. One study was terminated before recruiting sufficient participants due to a higher incidence of bleeding with the use of anticoagulants. The incidence of minor bleeding events was also slightly higher with anticoagulants.
Authors' conclusions
There is not enough evidence to make a definitive conclusion about the use of anticoagulant drugs (with or without mechanical devices) for DVT prophylaxis in patients undergoing abdominal aortic surgery.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD005509/frame.html
Ischaemic preconditioning for liver transplantation
KS Gurusamy, Y Kumar, D Sharma, BR Davidson
Abstract
Background
Ischaemic preconditioning is a mechanism for reducing organ ischaemia reperfusion injury by a brief period of organ ischaemia.
Objectives
To assess the advantages and disadvantages of ischaemic preconditioning during donor hepatectomy for liver transplant recipients.
Search strategy
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2007.
Selection criteria
We included only randomised clinical trials comparing ischaemic preconditioning versus no ischaemic preconditioning during donor liver retrievals performed in humans in this review (irrespective of language or publication status).
Data collection and analysis
We collected the data on the characteristics of the trial, methodological quality of the trials, mortality, initial poor function, primary graft non-function, re-transplantation, liver function tests, markers of neutrophil activation, apoptosis, and intensive therapy unit stay. We analysed the data with both the fixed-effect and the random-effects models. For each binary outcome we calculated the odds ratio (OR) with 95% confidence intervals (CI) based on intention-to-treat analysis. For continuous outcomes, we calculated the weighted mean difference (WMD) with 95% CI.
Main results
In three trials, 162 cadaveric liver donor retrievals were randomised; 78 to ischaemic preconditioning and 84 to no ischaemic preconditioning. In one trial, 15 living donor liver retrievals were randomised; 10 to ischaemic preconditioning and 5 to no ischaemic preconditioning. Three of the four trials were of low-risk bias. There was no statistically significant difference in mortality, initial poor function, primary graft non-function, or re-transplant. There was no statistically significant difference in the transaminase activity, bilirubin level, prothrombin activity, median myeloperoxidase activity, median cluster of differentiation eight (CD8) expression, median inducible nitrogen oxide synthetase, or apoptosis. There was also no significant difference in the median intensive therapy unit stay of the recipients.
Authors' conclusions
There is currently no evidence to support or refute the use of ischaemic preconditioning in donor liver retrievals. Further studies are necessary to identify the optimal ischaemic preconditioning stimulus. Further randomised clinical trials are necessary to evaluate the role of ischaemic preconditioning in donor liver retrievals involving a period of warm reperfusion, following ischaemic preconditioning during donor liver retrieval.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006315/frame.html
Back to the top
Surgical hand antisepsis to reduce surgical site infection
J Tanner, S Swarbrook, J Stuart
Abstract
Background
Surgical hand antisepsis, to destroy transient micro-organisms and inhibit the growth of resident micro-organisms, is routinely carried out before undertaking invasive procedures. Antisepsis may reduce the risk of surgical site infections in patients.
Objectives
To determine the effects of surgical hand antisepsis on the number of surgical site infections (SSIs) in patients. The secondary objective is to determine the effects of surgical hand antisepsis on the numbers of colony forming units (CFUs) of bacteria on the hands of the surgical team.
Search strategy
We searched the Cochrane Wounds Group Specialised Register (June 2007), the Cochrane Central Register of Controlled Trials (Issue 2, 2007), MEDLINE (Week 5, 2007), CINAHL (June 2007), EMBASE (Week 23, 2007) and ZETOC (2005).
Selection criteria
Randomised controlled trials comparing surgical hand antisepsis of varying duration, methods and antiseptic solutions.
Data collection and analysis
Three authors independently assessed studies for selection, trial quality and extracted data.
Main results
Ten trials were included in this review. Only one trial reported the primary outcome, rates of SSIs, and nine trials measured numbers of CFUs.
One trial involving 4387 patients found alcohol rubs with additional active ingredients were as effective as aqueous scrubs in reducing SSIs.
Four trials compared different alcohol rubs containing additional active ingredients with aqueous scrubs for numbers of CFUs on hands. One trial found N-duopropenide more effective than chlorhexidine and povidone iodine aqueous scrubs. One trial found 45% propanol-2, 30% propanol-1 with 0.2% ethylhexadecyldimethyl ammonium ethylsulfate more effective than chlorhexidine scrubs. One trial found no difference between 1% chlorhexidine gluconate in 61% ethyl alcohol or zinc pyrithione in 70% ethyl alcohol against aqueous povidone iodine. A fourth trial found 4% chlorhexidine gluconate scrubs more effective than chlorhexidine in 70% alcohol rubs.
Four trials compared the relative effects of different aqueous scrubs in reducing CFUs on hands. Three trials found chlorhexidine gluconate scrubs were significantly more effective than povidone iodine scrubs. One trial found no difference between chlorhexidine gluconate scrubs and povidone iodine plus triclosan scrubs.
Two trials found no evidence of a difference between alternative alcohol rubs in terms of the number of CFUs.
Four trials compared the effect of different durations of scrubs and rubs on the numbers of CFUs on hands. One trial found no difference after the initial scrub but found subsequent three minute scrubs using chlorhexidine significantly more effective than subsequent scrubs lasting 30 seconds. One trial found that following a one minute hand wash, a three minute rub appears to be more effective than the five minute rub using alcohol disinfectant. The other comparisons demonstrated no difference.
Authors' conclusions
Alcohol rubs used in preparation for surgery by the scrub team are as effective as aqueous scrubbing in preventing SSIs however this evidence comes from only one, equivalence, cluster trial which did not appear to adjust for clustering.
Four comparisons suggest that alcohol rubs are at least as, if not more, effective than aqueous scrubs though the quality of these is mixed and each study presents a different comparison, precluding meta analysis. There is no evidence to suggest that any particular alcohol rub is better than another. Evidence from 4 studies suggests that chlorhexidine gluconate based aqueous scrubs are more effective than povidone iodine based aqueous scrubs in terms of the numbers of CFUs on the hands.
There is limited evidence regarding the effects on CFUs numbers of different scrub durations. There is no evidence regarding the effect of equipment such as brushes and sponges.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004288/frame.html
Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults
U Traut, L Brügger, R Kunz, C Pauli-Magnus, K Haug, HC Bucher, MT Koller
Abstract
Background
Postoperative adynamic bowel atony interferes with recovery following abdominal surgery. Prokinetic pharmacologic drugs are widely used to accelerate postoperative recovery.
Objectives
To evaluate the benefits and harms of systemic acting prokinetic drugs to treat postoperative adynamic ileus in patients undergoing abdominal surgery.
Search strategy
Trials were identified by computerised searches of the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and the Cochrane Colorectal Cancer Group specialised register. The reference lists of included trials and review articles were tracked and authors contacted.
Selection criteria
Randomised controlled parallel-group trials (RCT) comparing the effect of systemically acting prokinetic drugs against placebo or no intervention.
Data collection and analysis
Four reviewers independently extracted the data and assessed trial quality. Trial authors were contacted for additional information if needed.
Main results
Thirty-nine RCTs met the inclusion criteria contributing a total of 4615 participants. Most trials enrolled a small number of patients and showed moderate to poor (reporting of) methodological quality, in particular regarding allocation concealment and intention-to-treat analysis. Fifteen systemic acting prokinetic drugs were investigated and ten comparisons could be summarized. Six RCTs support the effect of Alvimopan, a novel peripheral mu receptor antagonist. However, the trials do not meet reporting guidelines and the drug is still in an investigational stage. Erythromycin showed homogenous and consistent absence of effect across all included trials and outcomes. The evidence is insufficient to recommend the use of cholecystokinin-like drugs, cisapride, dopamine-antagonists, propranolol or vasopressin. Effects are either inconsistent across outcomes, or trials are too small and often of poor methodological quality. Cisapride has been withdrawn from the market due to adverse cardiac events in many countries. Intravenous lidocaine and neostigmine might show a potential effect, but more evidence on clinically relevant outcomes is needed. Heterogeneity among included trials was seen in 10 comparisons. No major adverse drug effects were evident.
Authors' conclusions
Alvimopan may prove to be beneficial but proper judgement needs adherence to reporting standards. Further trials are needed on intravenous lidocaine and neostigmine. The remaining drugs can not be recommended due to lack of evidence or absence of effect.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004930/frame.html
Back to the top
Cryoplasty for peripheral vascular disease
JE McCaslin, S Macdonald, G Stansby
Abstract
Background
In the UK, symptomatic peripheral arterial disease (PAD) occurs in 5 to 7% of people over the age of 55 years. Cryoplasty offers a new approach by combining the dilation force of balloon angioplasty with the delivery of cold thermal energy to the vessel wall. Cryoplasty is thought to provoke apoptosis rather than necrosis in the arterial smooth muscle cells and thus has the theoretical advantage of reduced myointimal hyperplasia in long-term patency.
As it is an emerging therapy, safety and efficacy questions remain. This systematic review evaluates the treatment and provide focus for further research in the field.
Objectives
To assess the efficacy of, and complications associated with, cryoplasty for maintaining patency in the iliac or infrainguinal arteries.
Search strategy
We searched the Specialized Register of the Cochrane Peripheral Vascular Diseases Group (inception to August 2007), the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2007, Issue 3, along with MEDLINE (1966 to August 2007) and EMBASE (1980 to August 2007).
Selection criteria
Trials in which patients with peripheral arterial disease (PAD) of the iliac or infrainguinal arteries were randomised to cryoplasty with or without another procedure versus a procedure without cryoplasty. This includes trials where all patients receive angioplasty and the randomisation is for cryoplasty versus none.
Data collection and analysis
Studies identified for potential inclusion were independently assessed for inclusion by at least two authors, with excluded trials arbitrated by the third author. As no randomised controlled trials of cryoplasty were found, no statistical analyses were performed.
Main results
No randomised controlled trials of cryoplasty were identified.
Authors' conclusions
The benefit of cryoplasty over conventional angioplasty has not been established as no randomised controlled trials exist to properly evaluate this method. Technical success and primary patency rates seen in the prospective series are encouraging and may suggest a future role for cryoplasty in the treatment of PAD, but cannot be reliably interpreted due to the nature of the studies.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD005507/frame.html
Methods of vascular occlusion for elective liver resections
KS Gurusamy, Y Kumar, D Sharma, BR Davidson
Abstract
Background
Vascular occlusion is used to reduce blood loss during liver resection surgery. There is considerable controversy regarding whether vascular occlusion should be used or not during elective liver resections. The method of vascular occlusion employed is also controversial. There is also considerable debate on the role of ischaemic preconditioning before vascular occlusion.
Objectives
To assess the advantages (decreased blood loss and peri-operative morbidity) and disadvantages (liver dysfunction from ischaemia) of vascular occlusion during liver resections.
To compare the advantages (in decreasing blood loss or decreasing ischaemia-reperfusion injury) and disadvantages of different types of vascular occlusion versus total, continuous portal triad clamping.
Search strategy
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2007.
Selection criteria
We included randomised clinical trials comparing vascular occlusion versus no vascular occlusion during elective liver resections (irrespective of language or publication status). We also included randomised clinical trials comparing the different methods of vascular occlusion and those investigating the role of ischaemic preconditioning in liver resection.
Data collection and analysis
We collected the data on the characteristics of the trial, methodological quality of the trials, mortality, morbidity, blood loss, blood transfusion requirements, liver function tests, markers of neutrophil activation, operating time, and hospital stay. We analysed the data with both the fixed-effect and the random-effects models using RevMan Analysis. For each binary outcome we calculated the odds ratio (OR) with 95% confidence intervals (CI) based on intention-to-treat analysis. For continuous outcomes, we calculated the weighted mean difference (WMD) with 95% confidence intervals.
Main results
We identified a total of 16 randomised trials. Five trials including 331 patients compared vascular occlusion (n = 166) versus no vascular occlusion (n = 165). Six trials including 521 patients compared different methods of vascular occlusion. Three trials including 210 patients compared ischaemic preconditioning before continuous portal triad clamping (n = 105) versus no ischaemic preconditioning (n = 105). Two trials including 127 patients compared ischaemic preconditioning before continuous portal triad clamping (n = 63) versus intermittent portal triad clamping (n = 64).
The blood loss was significantly lower in vascular occlusion compared with no vascular occlusion. The liver enzymes were significantly elevated in the vascular occlusion group compared with no vascular occlusion. There was no difference in the mortality, liver failure, or other morbidities. Four of the five trials comparing vascular occlusion and no vascular occlusion used intermittent vascular occlusion. Trials comparing complete inflow and outflow occlusion to the liver, ie, hepatic vascular exclusion and portal triad clamping demonstrate significant detrimental haemodynamic changes in hepatic vascular exclusion compared to portal triad clamping. There was no significant difference in the number of units transfused and the number of patients needing transfusion. There was no difference in mortality, liver failure, or morbidity between total and selective methods of portal triad clamping. All four cases of mortality and liver failure in the comparison between the intermittent and continuous portal triad clamping occurred in the continuous portal triad clamping (statistically not significant). Intermittent portal triad clamping does not increase the total blood loss or operating time compared to continuous portal triad clamping.
There was no statistically significant difference in the mortality, liver failure, morbidity, blood loss, or haemodynamic changes between ischaemic preconditioning versus no ischaemic preconditioning before continuous portal triad clamping. Liver enzymes used as markers of liver injury were significantly lower in the early post-operative period in the ischaemic preconditioning group. The intensive therapy unit stay and hospital stay were statistically significantly lower in the ischaemic preconditioning group than in the no ischaemic preconditioning group.
There was no statistically significant difference in the mortality, liver failure, morbidity, intensive therapy unit stay, or hospital stay between ischaemic preconditioning before continuous portal triad clamping and intermittent portal triad clamping. The blood loss and transfusion requirements were lower in the ischaemic preconditioning group. Aspartate aminotransferase level was lower in the intermittent portal triad clamping group than the ischaemic preconditioning group on the third post-operative day. There was no difference in the peak aspartate aminotransferase levels or in the aspartate aminotransferase levels on first or sixth post-operative days of aspartate aminotransferase .
Authors' conclusions
Intermittent vascular occlusion seems safe in liver resection. However, it does not seem to decrease morbidity. Among the different methods of vascular occlusion, intermittent portal triad clamping has most evidence to support the clinical application. Hepatic vascular exclusion cannot be recommended routinely. Ischaemic preconditioning before continuous portal triad clamping may be of clinical benefit in reducing intensive therapy unit and hospital stay.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006409/frame.html
Back to the top
Single dose oral lumiracoxib for postoperative pain
YM Roy, S Derry, RA Moore
Abstract
Background
Lumiracoxib is a novel selective cyclooxygenase-2 (COX-2) inhibitor. COX-2 inhibitors have been developed to avoid COX-1 related gastrointestinal (GI) problems. Lumiracoxib has analgesic and anti-inflammatory activity comparable with traditional non-steriodal anti-inflammatory drugs (tNSAIDs) in the management of post-operative pain, but with the advantage of better GI tolerability.
Objectives
To review the analgesic efficacy, duration of analgesia, and adverse effects of a single oral dose of lumiracoxib for moderate to severe postoperative pain in adults and compare it with established analgesics.
Search strategy
We searched CENTRAL (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to March 2007), EMBASE (1974 to 2006), and PubMed (February 2007).
Selection criteria
Single oral dose, randomised placebo controlled trials of lumiracoxib, in acute postoperative pain, in adult patients.
Data collection and analysis
Trials were quality scored and data extracted by two review authors independently. Summed pain relief (TOTPAR) was extracted and converted into dichotomous information yielding the number of patients with at least 50% pain relief. These derived results were used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief.
Main results
Three studies (737 patients) met the inclusion criteria. In total 211 patients were treated with lumiracoxib 400 mg, 51 with lumiracoxib 100 mg, and 161 with placebo. Active comparators were naproxen 500 mg (60 patients), rofecoxib 50 mg (102), celecoxib 200 mg (101), and ibuprofen 400 mg (51). One hundred patients (48%) given lumiracoxib 400 mg had at least 50% pain relief over six hours, compared with 17 (11%) given placebo; RB 4.8 (95% CI 2.9 to 7.9), NNT 2.7 (2.2 to 3.5).
Weighted median time to use of rescue medication was 7.4 hours for lumiracoxib 400 mg and 1.8 hours for placebo. Patient global assessment at study endpoint was rated as "excellent" by 71 patients (34%) given lumiracoxib 400 mg and 5 (3%) given placebo. Median time to onset of analgesia was shorter for lumiracoxib 400 mg (0.6 to 1.5 hours) than placebo (>12 hours), and use of rescue medication within 12 hours occurred in 64 patients (58%) given lumiracoxib 400 mg and 100 (91%) given placebo.
Adverse events reported were generally mild to moderate in severity, with one serious adverse event reported in a patient given placebo.
Authors' conclusions
Lumiracoxib 400 mg given as a single oral dose, is an effective analgesic for acute postoperative pain.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006865/frame.html
Use of plastic adhesive drapes during surgery for preventing surgical site infection
J Webster, A A Alghamdi
Abstract
Background
Surgical site infection has been estimated to occur in about 15% of clean surgery and 30% of contaminated surgery. Using plastic adhesive drapes to protect the wound from organisms that may be present on the surrounding skin during surgery is one strategy used to prevent surgical site infection. Results from non-randomised studies have produced conflicting results about the efficacy of this approach but no systematic review has been conducted to date to guide clinical practice.
Objectives
To assess the effect of adhesive drapes used during surgery on surgical site infection, cost, mortality and morbidity.
Search strategy
We searched the Cochrane Wounds Group Specialised Register (last searched 24/4/07), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2,2007), Ovid MEDLINE (1950 to April Week 2, 2007), Ovid EMBASE (1980 to 2007 Week 16), and Ovid CINAHL (1982 to 1980 to April Week 2 2007).
Selection criteria
Randomised controlled trials comparing any plastic adhesive drape with no adhesive drape, used alone or in combination with woven (material) drapes or disposable (paper) drapes in patients undergoing any type of surgery.
Data collection and analysis
Two authors independently selected and assessed studies for trial quality and both independently extracted data. Study authors were contacted for additional information.
Main results
This review includes five studies involving 3,082 participants comparing adhesive drapes with no drape and two studies involving 1,113 participants comparing iodine-impregnated adhesive drapes with no drape. A significantly higher proportion of patients in the adhesive drape group developed a surgical site infection when compared with no drape. (Relative Risk (RR) 1.23, 95% Confidence Intervals (CI) 1.02 to 1.48, p=0.03). Iodine-impregnated adhesive drapes had no effect on the surgical site infection rate (RR 1.03, 95% CI 0.064 to 1.66, p=0.89). Length of hospital stay was similar in adhesive drape and non-adhesive drape groups.
Authors' conclusions
There was no evidence from the seven trials that plastic adhesive drapes reduces surgical site infection rate and some evidence that they increase infection rates.
Further trials may be justified using blinded outcome assessment to examine the effect of adhesive drapes on surgical site infection based on different wound classifications.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006353/frame.html
Back to the top
|
