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At least 1,315 records · Page 73Linked to original sources
PubMed2005

Transabdominal pre-peritoneal (TAPP) versus totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair: a systematic review.

BACKGROUND: The choice of approach to the laparoscopic repair of inguinal hernia is controversial. There is a scarcity of data comparing the laparoscopic transabdominal preperitoneal (TAPP) approach with the laparoscopic totally extraperitoneal (TEP) approach, and questions remain about their relative merits and risks. METHODS: Electronic databases were searched to identify reports of trials comparing laparoscopic TAPP with laparoscopic TEP. In addition, selected conference proceedings were hand-searched, websites consulted, reference lists of all included papers were scanned, and experts contacted for other potentially eligible reports. All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic TAPP with laparoscopic TEP for inguinal hernia repair were eligible for inclusion. Large non-randomised prospective studies were also eligible for inclusion to provide further comparative evidence of complications and serious adverse events. Two reviewers independently extracted data and assessed study quality. Statistical analyses were performed using the fixed effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes with 95% confidence intervals (CI). RESULTS: The search identified one RCT which reported no statistically significant difference between TAPP and TEP when considering duration of operation, haematoma, length of stay, time to return to usual activities, and recurrence. The eight non-randomised studies suggest that TAPP is associated with higher rates of port-site hernias and visceral injuries whilst there appear to be more conversions with TEP. Vascular injuries and deep/mesh infections were rare and there was no obvious difference between the groups. No studies reporting economic evidence were identified. CONCLUSIONS: There is insufficient data to allow conclusions to be drawn about the relative effectiveness of TEP compared with TAPP. Efforts should be made to start and complete adequately-powered randomised controlled trials (RCTs), which compare the different methods of laparoscopic repair.

Female↗
PubMed2003

Review article: the management of acute variceal bleeding.

Variceal haemorrhage is a common medical emergency with a high mortality (30-50%). Adequate resuscitation is vital, and once stabilised the patient should be moved to a high-dependency area. Antibiotics reduce mortality, and the vasoactive drug terlipressin should be administered if early endoscopy is unavailable. Early endoscopy is essential both to make the diagnosis and to allow therapeutic measures to be performed. The evidence suggests that variceal band ligation is the most effective therapy for oesophageal varices. If gastric varices are found at the index endoscopy the evidence at present is inadequate to be certain which is the best treatment, but both endoscopic therapy with cyanoacrylate or thrombin and transjugular intrahepatic portosystemic stent shunt (TIPSS) have been reported to be of benefit. When initial treatments fail, rescue therapy should be initiated. Most authorities agree that TIPSS is the rescue therapy of choice. Many questions remain concerning the treatment of acute variceal bleeding, particularly the ideal therapy for gastric varices and the role of combination vasoactive and endoscopic therapy. Randomised controlled trials are required to answer these important issues.

Acute Disease↗
PubMed1997

A systematic review of compression treatment for venous leg ulcers.

OBJECTIVE: To estimate the clinical and cost effectiveness of compression systems for treating venous leg ulcers. METHODS: Systematic review of research. Search of 19 electronic databases including Medline, CINAHL, and Embase. Relevant journals and conference proceedings were hand searched and experts were consulted. MAIN OUTCOME MEASURES: Rate of healing and proportion of ulcers healed within a time period. STUDY SELECTION: Randomised controlled trials, published or unpublished, with no restriction on date or language, that evaluated compression as a treatment for venous leg ulcers. RESULTS: 24 randomised controlled trials were included in the review. The research evidence was quite weak: many trials had inadequate sample size and generally poor methodology. Compression seems to increase healing rates. Various high compression regimens are more effective than low compression. Few trials have compared the effectiveness of different high compression systems. CONCLUSIONS: Compression systems improve the healing of venous leg ulcers and should be used routinely in uncomplicated venous ulcers. Insufficient reliable evidence exists to indicate which system is the most effective. More good quality randomised controlled trials in association with economic evaluations are needed, to ascertain the most cost effective system for treating venous leg ulcers.

Bandages↗
PubMed1994

[Discussion comment: surgical therapy of thrombosis of leg and pelvic veins].

Referring to a survey of the literature and the own clinical series the open problems in the surgical treatment of acute iliofemoral venous thrombosis are discussed. Only 2 reports have been published, which test 2 therapeutical options, surgery versus oral anticoagulant treatment in a randomised trial. Nevertheless there have been some shortcomings. Therefore a further clinical trial, with multicentre design, probably guided by a scientific society, seems justified to settle the remaining questions.

Femoral Vein↗
PubMed2003

Leflunomide for the treatment of rheumatoid arthritis.

Leflunomide (Arava), Aventis Pharmaceuticals) is an immunomodulating drug that interferes with the metabolism of pyrimidine by inhibiting dihydro-orotate dehydrogenase (DHO-DH) in mitochondria, thereby blocking T- and B cell proliferation. Antibody production is also affected by DHO-DH blockade. Other immunomodulatory effects of leflunomide have also been reported. Symptomatic and structural effects of leflunomide in active rheumatoid arthritis have been strictly evaluated by double-blind, randomised, placebo-controlled studies that were aimed at validating its use in rheumatoid arthritis. Further trials are now required to confirm efficacy and safety of this drug in combination with other agents.

Arthritis, Rheumatoid↗
PubMed2004

Is acetaminophen, and its combination with pamabrom, an effective therapeutic option in primary dysmenorrhoea?

Primary dysmenorrhoea is the most frequent gynaecological condition, with a prevalence of 40 - 90% in women within the reproductive age. It is characterised by cyclic pelvic pain related to menstrual period, vomiting and headache. As prostaglandins and leukotrienes appear to be a major causative factor in this condition, NSAIDs are the first choice for treatment. Acetaminophen is an over-the-counter analgesic/antipyretic agent widely used in primary dysmenorrhoea as monotherapy or in combination. It has a weak inhibitory action on peripheral prostaglandin synthesis. Acetaminophen displays good gastrointestinal tolerance without any effect on haemostasis. Its combination with pamabrom, a mild diuretic agent, (Women s Tylenol Menstrual Relief Caplets, Midol Teen) was approved by the FDA for use in this indication. Nevertheless, the available information concerning the efficacy of acetaminophen in primary dysmenorrhoea is limited and not conclusive with respect to other NSAIDs or even placebo. The clinical evidence regarding the association with pamabrom is even more scarce. Well-designed, randomised, controlled trials are required to demonstrate the efficacy of the combination of acetaminophen plus pamabrom in the treatment of primary dysmenorrhoea.

Acetaminophen↗
PubMed1982

Thyroidectomy: is Lugol's iodine necessary?

In a randomised controlled clinical trial of Lugol's iodine against placebo in 44 patients undergoing thyroidectomy we have failed to show any benefit in terms of reduced bleeding or operative facility after using iodide solution.

Adult↗
PubMed2001

Transfusion practice in primary unilateral total knee replacement arthroplasty; the need for guidelines.

BACKGROUND AND AIMS: There are no universally accepted guidelines for blood transfusion in primary, unilateral Total Knee Replacement Arthroplasty (TKA). Transfusion is associated with post-operative infection, fluid overload and prolonged duration of hospitalisation. Due to this morbidity and reports of "inappropriate" transfusion practice, an audit of the local practice was organised, with the aim of assessing compliance to existing evidence. METHODS: A 1-year retrospective survey of blood transfusion practice was conducted for all consecutive elective, primary, unilateral TKA operations. RESULTS: 169 operations were performed; 96% for osteoarthritis; mean patient age was 69 years; 66% were females; 34% of the patients were transfused, 60% intra-operatively. There was no threshold of pre-operative Hb predictive of a transfusion and no significant difference in the pre-operative Hb between transfused and non-transfused groups. Only 26% of the cross-matched blood was eventually transfused. Intra-operative blood loss was negligible and only 10% of transfused patients had shown cardiovascular instability. The post-operative Hb drop was maximal at around day-4. CONCLUSIONS: The lack of guidelines has led to inconsistent local transfusion practice, often with no scientific evidence to support it. In the absence of a randomised controlled trial addressing the issue, certain transfusion guidelines are suggested, based on existing indirect scientific evidence.

Aged↗
PubMed1997

The drug trials that have influenced our clinical practice in acute ischaemic stroke.

With the possible exception of aspirin, there are still no drug treatments which have been found to be so effective in randomised controlled trials, and meta-analyses of such trials, that they should be used routinely in acute ischaemic stroke. The evidence on thrombolysis is tantalising but with only about 3500 randomised patients in all the trials put together it is too early to say how, and for whom, this promising treatment should be used, particularly bearing in mind the risk of intracranial haemorrhage; the evidence so far is enough to persuade us to enter our patients into further large trials of thrombolysis but it is not enough to justify this treatment in our routine clinical practice.

Fibrinolytic Agents↗
PubMed2000

Non-steroidal anti-inflammatory drugs for preventing heterotopic bone formation after hip arthroplasty.

BACKGROUND: Heterotopic bone formation (HBF) in the soft tissues surrounding the hip joint is a frequent complication of hip surgery. Non-steroidal anti-inflammatory drugs (NSAIDs) administered in the immediate perioperative period reduce the risk of HBF. However, the magnitude of the effect on HBF, and the effects on other associated outcomes are uncertain. OBJECTIVES: To determine the effects of perioperative NSAID therapy versus control on the risk of HBF and other outcomes in patients undergoing hip arthroplasty. SEARCH STRATEGY: Medline, Current Contents and Cochrane Controlled Trials Register, and reference lists of all relevant reports were searched. Principal investigators and the manufacturers of the study drugs of eligible trials were approached. The most recent search was conducted in July 1998. SELECTION CRITERIA: All trials which enrolled patients scheduled to undergo hip arthroplasty with random or quasi-random allocation to perioperative NSAID or control and that recorded post-operative radiographically determined HBF. The primary outcome was post-operative radiographic HBF. Secondary outcomes were pain, disability, gastro-intestinal and other bleeding complications, and other causes of major morbidity or mortality. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality and extracted data. All analyses were conducted on dichotomised outcomes. MAIN RESULTS: Twelve randomised and two quasi-randomised trials involving a total of 4,377 patients were included. Overall, in 13 trials that examined the effects of medium to high doses of NSAIDs, there was a reduced risk of developing HBF after hip surgery (62% reduction, 95% confidence interval 56% to 67% reduction). In contrast, one large trial examining low-dose aspirin, demonstrated no effect on the risk of HBF (2% reduction, 95% confidence interval 15% reduction to 12% increase). There was strong evidence of differences in the size of the treatment effects observed between the trials examining medium to high doses of NSAIDs, but reasons were not clearly identified. There was a non-significant one third increased risk of gastro-intestinal side effects among patients assigned NSAIDs (29% increase, 95% confidence interval 5% reduction to 76% increase). Most of this increase was due to an increased risk of minor gastro-intestinal complications. Data on the late post-operative outcomes of pain, impaired physical function and range of joint movement were few and no formal overviews of the effects of NSAIDs on these outcomes were possible. REVIEWER'S CONCLUSIONS: Perioperative NSAIDs appear to produce between a one half and two thirds reduction in the risk of HBF. With routine use, such agents may be able to prevent 15-20 cases of HBF (3-4 severe) among every 100 total hip replacements performed. However, while medium to high doses of perioperative NSAIDs clearly produce a substantial reduction in the incidence of radiographic HBF, there remains some uncertainty about short-term side effects of treatment and substantial uncertainty about effects on long-term clinical outcomes such as chronic pain and impaired physical function. The net effect of routine HBF prophylaxis with NSAIDs requires formal assessment in a randomised trial designed to determine the balance of benefits and risks for all outcomes.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1994

Treatment-related deaths in small cell lung cancer trials: can patients at risk be identified? Medical Research Council Lung Cancer Working Party.

OBJECTIVES: This paper investigates the problem of treatment-related deaths in small cell lung cancer (SCLC). DESIGN: To observe and define increased hazard levels, and to identify factors relating to these excess deaths. SETTING: The United Kingdom. SUBJECTS: A total of 2196 patients entered into the series of six randomised clinical trials in SCLC conducted by the Medical Research Council (MRC) Lung Cancer Working Party (LCWP). RESULTS: In this large series of patients an increased risk of death in the second week after commencing the first cycle of chemotherapy was observed, suggesting that of the 10% of patients who died within 3 weeks of starting chemotherapy, half may have been treatment-related. Much less additional risk was associated with subsequent cycles of chemotherapy, and no additional risk with either initial surgery or radiotherapy. Radford et al. [Eur J Cancer 1993; 29A: 81-86] suggested that the risk factors for death from sepsis were a Karnofsky Performance (KP) score of < or = 50 (translated as a WHO performance grade (PS) > or = 3), age > 50 years and three or more drugs in the chemotherapy regimen utilised. Starting with this model we found that our data suggest it can be refined by omitting age and including a white blood cell count > or = 10,000/mm3 (this variable was not tested by Radford), and changing the other categories to WHO PS > or = 2 (KP < or = 70), and four or more drugs. Within our data this revised model identified a high risk group of patients with an excess death rate of more than 15% in the second week after starting chemotherapy. Radford et als' suggestion that high risk patients be given half doses of drugs at the first cycle should be tested in a randomised clinical trial.

Aged↗
PubMed2003

Palliative therapy of disseminated malignant melanoma: a systematic review of 41 randomised clinical trials.

We undertook a systematic review of 41 randomised studies in disseminated melanoma, identified by a comprehensive search. We aimed to investigate rates of response to various treatment modalities and the outcome for the patients. We analysed seven studies that compared polychemotherapy with single-agent dacarbazine, six that compared different chemotherapeutic schedules with each other, five on the addition of tamoxifen to a reference therapy, and six that included non-specific immunostimulators. In 17 studies, the addition of interferon alfa, interleukin 2, or both, to a reference therapy was investigated, including trials with biochemotherapy. Many trials had small sample sizes and did not report a power analysis; not all were analysed by intention to treat. Although some treatment regimens, especially polychemotherapeutic schedules, seem to increase response rates, none of the treatment schedules was proven to prolong overall survival. Patients with disseminated melanoma should be treated with well-tolerated drug regimens, such as single-agent treatments or in combination with interferon alfa. Systemic treatments should preferably be investigated in randomised trials so that the potential benefits of new treatment concepts can be thoroughly examined.

Antineoplastic Agents↗
PubMedDate not supplied

Estimating the causal effects of treatment.

OBJECTIVE: To provide a relatively non-technical review of recent statistical research on the analysis and interpretation of the results of randomised controlled trials in which there are possibly all three of the following types of protocol violation: non-adherence to allocated treatment, contamination (that is, patients receiving treatments other than the one to which they were allocated) and attrition (missing outcome data). METHODS: The estimation methods involve the use of potential outcomes (counterfactuals) in the definition of a causal effect of treatment and in drawing valid inferences concerning its size. RESULTS: The methods are explained through the use of simple arithmetical expressions involving the counts from three-way contingency tables (Outcome by Treatment Received by Random Allocation). Illustration is provided through the use of a hypothetical data set. CONCLUSIONS: Recent advances in statistical methodology enable one to estimate treatment effects from the results of randomized trials in which the treatment actually received is not necessarily the one to which the patient was allocated. These methods allow one to make adjustments to allow for both non-compliance and loss to follow-up. Even for such a 'broken' randomised trial, inference concerning causal effects is safer than that from data arising from an observational study that never involved random allocation in the first place.

Humans↗