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PubMed2005

Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To evaluate the most appropriate surgical method of hysterectomy (abdominal, vaginal, or laparoscopic) for women with benign disease. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Cochrane Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials, Medline, Embase, and Biological Abstracts. SELECTION OF STUDIES: Only randomised controlled trials were selected; participants had to have benign gynaecological disease; interventions had to comprise at least one hysterectomy method compared with another; and trials had to report primary outcomes (time taken to return to normal activities, intraoperative visceral injury, and major long term complications) or secondary outcomes (operating time, other immediate complications of surgery, short term complications, and duration of hospital stay). RESULTS: 27 trials (total of 3643 participants) were included. Return to normal activities was quicker after vaginal than after abdominal hysterectomy (weighted mean difference 9.5 (95% confidence interval 6.4 to 12.6) days) and after laparoscopic than after abdominal hysterectomy (difference 13.6 (11.8 to 15.4) days), but was not significantly different for laparoscopic versus vaginal hysterectomy (difference -1.1 (-4.2 to 2.1) days). There were more urinary tract injuries with laparoscopic than with abdominal hysterectomy (odds ratio 2.61 (95% confidence interval 1.22 to 5.60)), but no other intraoperative visceral injuries showed a significant difference between surgical approaches. Data were notably absent for many important long term patient outcome measures, where the analyses were underpowered to detect important differences, or they were simply not reported in trials. CONCLUSIONS: Significantly speedier return to normal activities and other improved secondary outcomes (shorter duration of hospital stay and fewer unspecified infections or febrile episodes) suggest that vaginal hysterectomy is preferable to abdominal hysterectomy where possible. Where vaginal hysterectomy is not possible, laparoscopic hysterectomy is preferable to abdominal hysterectomy, although it brings a higher chance of bladder or ureter injury.

Female↗
PubMed1993

Independence of salt intake from the hormones regulating calcium homeostasis.

Rats deprived of dietary calcium increase voluntary intake of NaCl solutions. We investigated whether the major hormones controlling calcium homeostasis are responsible for this increase in salt intake. Removing endogenous sources of calcitonin and parathyroid hormone by thyroidectomy and/or parathyroidectomy had no effect on NaCl intake. The surgically compromised rats and their intact controls drank similar amounts of NaCl in response to manipulations of diet calcium content. Despite normal NaCl intakes, rats with parathyroidectomy had low plasma calcium concentrations and a strong appetite for 50 mM CaCl2 solution. Chronic infusion of parathyroid hormone into rats with thyroparathyroidectomy decreased NaCl intake. Intact rats fed an American Institute of Nutrition (AIN)-76A-based vitamin D-deficient diet increased NaCl intake slightly and showed a strong appetite for CaCl2, but other rats maintained normocalcemic by the addition of calcium, phosphorus, and lactose to the vitamin D-deficient diet had normal NaCl and CaCl2 intakes. Chronic infusions of 1,25-dihydroxyvitamin D3 into intact rats had no effect on NaCl intake. Taken together, these results indicate that the increase in NaCl intake produced by calcium deprivation is not mediated by changes in circulating levels of calcium, calcitonin, parathyroid hormone, or 1,25-dihydroxyvitamin D3. Furthermore, the major calcium-regulating hormones are not involved in the control of "spontaneous" NaCl intake in the rat.

Animals↗
PubMed2006

Experimental background--review of animal studies.

UNLABELLED: Most of the research on the physiological effects of intramedullary nailing is technically difficult or ethically impossible to perform in humans. A substantial range of factors apply in clinical cases, which means that the data obtained from this source may lack the control needed to reveal the basic mechanisms of pathophysiology associated with this surgical procedure. Consequently, animal studies have been relied upon to provide answers that would otherwise be unavailable. This review manuscript summarizes the available literature on animal studies dealing with the local and systemic effects of intramedullary nailing. It focuses on whether these studies have contributed to our clinical knowledge of the procedure's impact on perfusion and fracture healing, as well as the medical relevance of coincident systemic effects. DATA SOURCES: Medline, personal library of the first author and of the Department of Trauma Surgery, University of Pittsburgh Medical Center. STUDY SELECTION: All animal studies on intramedullary stabilization published in English, German, and French. CONCLUSIONS: The relevance of animal studies investigating the impact of a surgical procedure and its influence on concomitant injuries depends on the design and the type of the animal model. If this fact is considered, and if a model is selected that simulates a systemic impact comparable with the clinical situation, then animal studies may provide a valuable source of otherwise unobtainable information. Such an example is the study of fat embolization associated with intramedullary nailing. Animal subjects enable assessment of the intervention's additive surgical impact, measurement of side effects that may have adverse results, and influence of cofactors (eg, thoracic trauma, severe shock, polytrauma) that predispose the individual to postoperative complications.

Animals↗
PubMed1998

Randomized, placebo-controlled, multicenter trial of granulocyte-macrophage colony-stimulating factor as infection prophylaxis in oncologic surgery. Leukine Surgical Prophylaxis Research Group.

PURPOSE: Postoperative infections are a frequent source of preventable morbidity and mortality in the oncologic population. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a potent modulator of immune effector cells in vitro and in vivo. This study was conducted to determine whether GM-CSF, when administered perioperatively, could reduce the incidence of surgical infections in cancer patients. METHODS: This was a prospective, randomized, placebo-controlled, multicenter study. Cancer patients at high risk of infectious surgical morbidity were randomized to receive GM-CSF 125 microg/m2 per day or placebo subcutaneously for 8 days beginning 3 days preoperatively. Routine antibiotic prophylaxis was administered to all patients. RESULTS: Three hundred ninety-nine patients were enrolled, with 198 randomized to receive GM-CSF. Twenty-one percent of patients experienced infections during the first 2 weeks postoperatively, and there was no difference in infection rate between the study groups. The most common sites of infection were respiratory tract (53%) and surgical wound (25%). The duration of operation and American Society of Anesthesiology (ASA) physical status classification were the most significant predictors of infection in multivariate analysis. GM-CSF was well tolerated and was not associated with fever. CONCLUSION: The eligibility criteria for this study were successful at defining a patient subgroup at high risk for postoperative infections. At an immunomodulatory dose of 125 microg/m2 per day, GM-CSF was safe and well tolerated, but did not reduce the incidence of postoperative infections in this high-risk oncologic population. Infectious morbidity in surgical oncology remains an important subject for continued clinical investigation.

Adult↗
PubMed2005

Energy sources for laparoscopic colectomy: a prospective randomized comparison of conventional electrosurgery, bipolar computer-controlled electrosurgery and ultrasonic dissection. Operative outcome and costs analysis.

The development of operative laparoscopic surgery is linked to advances in ancillary surgical instrumentation. Ultrasonic energy devices avoid the use of electricity and provide effective control of small- to medium-sized vessels. Bipolar computer-controlled electrosurgical technology eliminates the disadvantages of electrical energy, and a mechanical blade adds a cutting action. This instrument can provide effective hemostasis of large vessels up to 7 mm. Such devices significantly increase the cost of laparoscopic procedures, however, and the amount of evidence-based information on this topic is surprisingly scarce. This study compared the effectiveness of three different energy sources on the laparoscopic performance of a left colectomy. The trial included 38 nonselected patients with a disease of the colon requiring an elective segmental left-sided colon resection. Patients were preoperatively randomized into three groups. Group I had electrosurgery; vascular dissection was performed entirely with an electrosurgery generator, and vessels were controlled with clips. Group II underwent computer-controlled bipolar electrosurgery; vascular and mesocolon section was completed by using the 10-mm Ligasure device alone. In group III, 5-mm ultrasonic shears (Harmonic Scalpel) were used for bowel dissection, vascular pedicle dissection, and mesocolon transection. The mesenteric vessel pedicle was controlled with an endostapler. Demographics (age, sex, body mass index, comorbidity, previous surgery and diagnoses requiring surgery) were recorded, as were surgical details (operative time, conversion, blood loss), additional disposable instruments (number of trocars, EndoGIA charges, and clip appliers), and clinical outcome. Intraoperative economic costs were also evaluated. End points of the trial were operative time and intraoperative blood loss, and an intention-to-treat principle was followed. The three groups were well matched for demographic and pathologic features. Surgical time was significantly longer in patients operated on with conventional electrosurgery vs the Harmonic Scalpel or computed-based bipolar energy devices. This finding correlated with a significant reduction in intraoperative blood loss. Conversion to other endoscopic techniques was more frequent in Group I; however, conversion to open surgery was similar in all three groups. No intraoperative accident related to the use of the specific device was observed in any group. Immediate outcome was similar in the three groups, without differences in morbidity, mortality, or hospital stay. Analysis of operative costs showed no significant differences between the three groups. High-energy power sources specifically adapted for endoscopic surgery reduce operative time and blood loss and may be considered cost-effective when left colectomy is used as a model.

Adult↗
PubMed1993

Magnetic resonance-guided thermal surgery.

A demonstration of MR guided thermal surgery involved experiments with imaging of focused ultrasound in an MRI system, measurements of the thermal transients and a thermal analysis of the resulting images. Both the heat distribution and the creation of focused ultrasound lesions in gel phantoms, in vitro bovine muscle and in vivo rabbit muscle were monitored with magnetic resonance imaging. Thermal surgical procedures were modeled by an elongated gaussian heat source where heat flow is controlled by tissue thermal properties and tissue perfusion. Temperature profiles were measured with thermocouples or calculated from magnetic resonance imaging in agreement with the model. A 2-s T1-weighted gradient-refocused acquisition provided thermal profiles needed to localize the heat distribution produced by a 4-s focused ultrasound pulse. Thermal analysis of the images give an effective thermal diffusion coefficient of 0.0015 cm2/s in gel and 0.0033 cm2/s in muscle. The lesions were detected using a T2-weighted spin-echo or fast spin-echo pulse sequence in agreement with muscle tissue sections. Potential thermal surgery applications are in the prostate, liver, kidney, bladder, breast, eye and brain.

Acoustics↗
PubMed1977

Fiberoptic intraoperative illumination of the stomach as an aid in the management of acute gastric hemorrhage.

Intragastric illumination using a flexible light source is described as a technical aid in the management of gastric bleeding. The flexible light source can be recommended for illumination of the proximal intragastric area to facilitate surgical control of bleeding from Mallory-Weiss lacerations, ulcers, varices, and mucosal erosions. The sterile sheath-covered flexible neck of the light allows exact positioning of the light in the surgical field by the operating surgeon.

Fiber Optic Technology↗
PubMed2001

Antibiotic induced endotoxin release and clinical sepsis: a review.

Sepsis and peritonitis have not lost much of their danger for patients. The mortality rate in peritonitis has only marginally decreased during the last 30 years despite aggressive surgical and sophisticated intensive care treatment. In intra-abdominal infection and peritonitis source control remains the mainstay of treatment, although general principles and denominators of successful source control need to be established. Endotoxin has been recognized as a major player in the pathogenesis of sepsis and its significance in clinical disease has been investigated in clinical studies for more than 20 years. Since the Sixties there is a growing interest in the effect of antibiotics and other compounds on the release of endotoxin. The effect of antibiotics on the release of endotoxin and inflammatory parameters, e.g., cytokines, remains to be clarified despite a growing body of in-vitro studies, animal studies and a few clinical studies. The purpose of this review is to evaluate the evidence of endotoxin release in clinical studies and the effect that antibiotic treatment may have in-vitro, in-vivo and in clinical studies on endotoxin and cytokine release. In-vitro antibiotic-induced endotoxin release may depend on antibiotic class, presence of serum, type of organism, site of antibiotic action and Gram-stain. Endotoxin release may be different in late or early lysis, proportional to the number of killed pathogens. Morphology of bacteria may have an impact on endotoxin release and phagocytosis. Antibiotic-treated animals may show higher endotoxin levels with a higher survival rate than untreated animals. Plasma endotoxin may increase despite decreasing bacteremia. There may be a similar killing rate by different antibiotics but a difference in endotoxin release. Intestinal endotoxin does not necessarily correlate to the level of gram-negative bacteria. However, the alteration of the gut content by pretreatment may be associated with reduced endotoxemia and increased survival. Antibiotic-induced endotoxin release may be different depending on the type of infection, the location of infection, the virulence of strains, Gram-stain, mode of application and dosage of antibiotic. Different antibiotics may induce the release of different forms of endotoxin which may be lethal for sensitized animals. The combination of antibiotics with inhibitors of endotoxin or the pro-inflammatory response may be responsible for increased survival by decrease of endotoxin release. The clinical significance of antibiotic-induced endotoxin release is documented only in a few clinical disorders, e.g., meningitis, urosepsis. The difference in endotoxin release by PBP 2-specific antibiotics, e.g., imipenem, and PBP 3-specific antibiotics, e.g., ceftazidime, may not be visible in each study. Patients with increased multi-organ failure (MOF) scores may profit from treatment with antibiotics known to decrease endotoxin. In conclusion, the clinical significance of antibiotic-induced endotoxin release remains to be clarified. Type of pathogen and its virulence may be more important than recently suggested. gram-positive pathogens were just recently recognized as an important factor for the development of the host response. In case of fever of unknown origin in intensive care patients either failure of treatment, e.g., failure of source control in intra-abdominal infection, or a side effect of antibiotic treatment, e.g., endotoxin release, should be considered as a cause of the fever.

Animals↗
PubMed2004

Open abdomen management of intra-abdominal sepsis.

Despite surgical advances, antimicrobial therapy, and intensive care, the morbidity and mortality of intra-abdominal sepsis remains high. The primary purpose of this study was to determine whether open abdomen management of intra-abdominal sepsis reduces intensive care unit (ICU) and hospital mortality. The records of 81 consecutive patients with open abdomen management for intra-abdominal sepsis admitted to the surgical ICU from January 1998 to April 2002 were retrospectively reviewed. Outcomes were compared to a historical control group with primary abdominal closure, also admitted to the surgical ICU with intra-abdominal sepsis and matched for sex, age, source of sepsis, and APACHE III score. ICU mortality for the open abdomen group was 25 per cent versus 17 per cent for the control group. Hospital mortality was 33 per cent and 25 per cent for the open abdomen patients and historical controls, respectively. Both ICU and hospital length of stay were significantly longer for the open abdomen group. An overall fistula rate of 14.8 per cent was demonstrated in the open abdomen patients. A significant difference in overall ICU and hospital mortality was not demonstrated between patients treated with open abdomen management and historical controls. A prospective randomized study accounting for extent of sepsis may define a role for open abdomen management in selected subgroups of patients.

APACHE↗
PubMed2001

Enhanced superoxide production in experimental venous bypass graft intimal hyperplasia: role of NAD(P)H oxidase.

-Vein graft intimal hyperplasia, due to smooth muscle cell (SMC) proliferation, remains a limiting factor in long-term vein graft patency. Increased superoxide production regulates SMC mitogenesis and contributes to reduced NO bioactivity in systemic models of vascular disease. We compared superoxide production in experimental venous bypass grafts with ungrafted veins and determined its enzymatic sources and cellular localization. Vascular superoxide production was measured in vein grafts and control jugular veins obtained from normocholesterolemic rabbits undergoing jugular vein-carotid artery interposition bypass grafting. Surgical isolation of the contralateral jugular vein, without bypass grafting, provided an additional control for the effects of surgical manipulation. Superoxide production was increased 3-fold in vein grafts compared with control veins. Systematic stimulation and inhibition of specific oxidases revealed that the major source of increased vein graft superoxide production was a membrane-associated NAD(P)H-dependent oxidase. Western blotting of vascular homogenates demonstrated corresponding increases in NAD(P)H oxidase p22phox (membrane-associated) and p67phox (cytosolic) subunits in vein grafts compared with jugular veins. There was marked intimal hyperplasia in vein grafts, and immunohistochemical staining of vessel cryosections revealed increased p22phox-expressing cells in vein grafts that were predominantly intimal SMCs. Superoxide generation is increased in experimental vein grafts compared with ungrafted veins. The principal source of increased superoxide generation in vein grafts is an NAD(P)H oxidase, expressed by intimal SMCs. These findings suggest a role for NAD(P)H oxidase-mediated superoxide production in the proliferative response to vascular injury in vein grafts.

Animals↗
PubMed2005

Long-term seizure outcomes following epilepsy surgery: a systematic review and meta-analysis.

Assessment of long-term outcomes is essential in brain surgery for epilepsy, which is an irreversible intervention for a chronic condition. Excellent short-term results of resective epilepsy surgery have been established, but less is known about long-term outcomes. We performed a systematic review and meta-analysis of the evidence on this topic. To provide evidence-based estimates of long-term results of various types of epilepsy surgery and to identify sources of variation in results of published studies, we searched Medline, Index Medicus, the Cochrane database, bibliographies of reviews, original articles and book chapters to identify articles published since 1991 that contained > or =20 patients of any age, undergoing resective or non-resective epilepsy surgery, and followed for a mean/median of > or =5 years. Two reviewers independently assessed study eligibility and extracted data, resolving disagreements through discussion. Seventy-six articles fulfilled our eligibility criteria, of which 71 reported on resective surgery (93%) and five (7%) on non-resective surgery. There were no randomized trials and only six studies had a control group. Some articles contributed more than one study, yielding 83 studies of which 78 dealt with resective surgery and five with non-resective surgery. Forty studies (51%) of resective surgery referred to temporal lobe surgery, 25 (32%) to grouped temporal and extratemporal surgery, seven (9%) to frontal surgery, two (3%) to grouped extratemporal surgery, two (3%) to hemispherectomy, and one (1%) each to parietal and occipital surgery. In the non-resective category, three studies reported outcomes after callosotomy and two after multiple subpial transections. The median proportion of long-term seizure-free patients was 66% with temporal lobe resections, 46% with occipital and parietal resections, and 27% with frontal lobe resections. In the long term, only 35% of patients with callosotomy were free of most disabling seizures, and 16% with multiple subpial transections remained free of all seizures. The year of operation, duration of follow-up and outcome classification system were most strongly associated with outcomes. Almost all long-term outcome studies describe patient cohorts without controls. Although there is substantial variation in outcome definition and methodology among the studies, consistent patterns of results emerge for various surgical interventions after adjusting for sources of heterogeneity. The long-term (> or =5 years) seizure free rate following temporal lobe resective surgery was similar to that reported in short-term controlled studies. On the other hand, long-term seizure freedom was consistently lower after extratemporal surgery and palliative procedures.

Adolescent↗
PubMed1997

Prevention of central venous catheter-related bloodstream infection by use of an antiseptic-impregnated catheter. A randomized, controlled trial.

BACKGROUND: Bloodstream infection related to short-term use of noncuffed central venous catheters is a common and serious problem. Technologic innovations to reduce the risk for these infections are needed. OBJECTIVE: To determine 1) the efficacy of a novel antiseptic catheter in preventing central venous catheter-related infection, 2) patient tolerance of this catheter, and 3) the sources of bloodstream infection originating from noncuffed, multilumen central venous catheters. DESIGN: Randomized, controlled clinical trial. SETTING: Medical-surgical intensive care unit of a 450-bed university hospital. PARTICIPANTS: 158 adults scheduled to receive a central venous catheter; 403 catheters were studied. INTERVENTION: Participants received either a standard triple-lumen polyurethane catheter or a catheter that was indistinguishable from the standard catheter and was impregnated with chlorhexidine and silver sulfadiazine. MEASUREMENTS: Catheters were studied for colonization and catheter-related bloodstream infection at removal; local and systemic effects of catheters were assessed. The origin of each catheter-associated bloodstream infection was sought by culturing all potential sources (skin, catheter segments, hubs, and infusate) and confirmed by restriction-fragment DNA subtyping. RESULTS: Antiseptic catheters were less likely to be colonized at removal than control catheters (13.5 compared with 24.1 colonized catheters per 100 catheters; relative risk, 0.56 [95% CI, 0.36 to 0.89]; P = 0.005) and were nearly fivefold less likely to produce bloodstream infection (1.0 compared with 4.7 infections per 100 catheters; 1.6 compared with 7.6 infections per 1000 catheter-days; relative risk, 0.21 [CI, 0.03 to 0.95]; P = 0.03). In the control group, 8 catheter-related bloodstream infections were caused by Staphylococcus aureus, gram-negative bacilli, enterococci, or Candida species; no infections with these organisms occurred in the antiseptic catheter group (P = 0.003). No adverse effects from the antiseptic catheter were seen, and none of the 122 isolates obtained from infected catheters in either group showed in vitro resistance to chlorhexidine-silver sulfadiazine. Cost-benefit analysis indicated that the antiseptic catheter should prove cost-beneficial if an institution's rate of catheter-related bacteremia with noncuffed central venous catheters is at least 3 infections per 1000 catheter-days). CONCLUSIONS: The chlorhexidine-silver sulfadiazine catheter is well tolerated, reduces the incidence of catheter-related infection, extends the time that noncuffed central venous catheters can be safely left in place for the short term, and should allow cost savings.

Adult↗
PubMed1988

Intraoperative peritoneal lavage.

The successful management of the contaminated or septic abdomen rests on at least three tenets: The use of systemic perioperative antibiotics, the control of the source of infection and the aspiration of the gross contaminants. The additional use of any modality of IOPL is well entrenched in modern surgical practice. It does, however, owe more to force of habit or prejudice than to sound scientific evidence. Most, if not all, experimental or clinical studies suggesting the benefits of IOPL suffer from many deficiencies, some of which we made a point of emphasizing. In broad terms, one could recognize three major pitfalls invalidating these studies. First, the design of some of the experimental studies bears no resemblance to clinical situations. For example, laparotomy was omitted in either both arms of the trial or in the control arm. Second, far too frequently, the data were drawn from retrospective or uncontrolled trials. Although the value of such studies cannot be denied, the literature is replete with examples of perpetuation of erroneuos concepts through lack of properly designed prospective, randomized controlled studies. Third, many of the trials were performed before the revolutionary introduction of perioperative antibiotics in clinical practice. Of greater concern is the existence of studies which, for unexplained reasons, have ignored this principle. From this review, it seems that neither the benefit nor the safety of IOPL with crystalloid or antiseptic solution has been established beyond any reasonable doubt. The theory for the addition of judicious antibiotics to the IOPL may be stronger, although no absolute proof exists to suggest that this practice will decrease mortality rates from intra-abdominal infections. Obviously, there is a need for well constructed, controlled, prospective clinical trials to examine the role of IOPL in modern surgical groups of patients assembled under the label intra-abdominal infection. Until some stratification of peritonitis in various clinical studies is undertaken, either by how ill the patient is or the source of contamination and its duration, it will be difficult to compare studies from different centers.

Humans↗
PubMed1996

Acremonium kiliense endophthalmitis that occurred after cataract extraction in an ambulatory surgical center and was traced to an environmental reservoir.

During October and November 1993, four patients contracted Acremonium kiliense endophthalmitis at one ambulatory surgical center. We hypothesized that the source was environmental and conducted a matched case-control study, environmental evaluation, and observational studies. Case and control patients were similar in clinical characteristics. However, case patients all had surgery on the first operative day of the week or had surgery significantly sooner after the operating room opened than did controls (a median of 46 vs. 150 minutes afterward; P = .03). An environmental review revealed the ventilation system was switched on 5-30 minutes before procedures began on the first operative day of the week, and air was filtered before but not after humidification. Cultures of the humidifier water in the ventilation system yielded A. kiliense phenotypically identical to isolates from case patients. Our data suggest that switching on the ventilation system each week aerosolized a reservoir of A. kiliense and caused infection of patients. We believe this is the first reported outbreak of fungal endophthalmitis traced to an environmental source, and it underscores the importance of utilizing established hospital infection control practices in the outpatient setting.

Acremonium↗
PubMed2002

Randomized controlled trials for evaluating surgical questions.

OBJECTIVE: To discuss some of the obstacles inherent in the design of the randomized controlled trial (RCT) that the surgeon must confront and options to minimize these obstacles. DATA SOURCES: The literature was searched for articles discussing RCTs using MEDLINE from 1966 to 1998. STUDY SELECTION: Studies relevant to the general use of RCTs for evaluating surgical questions were selected. SYNTHESIS: Several problems inherent in RCTs were noted: (1) ethical considerations, (2) difficulties in patient accrual, (3) patient preferences, and (4) variability in surgical proficiency/technique. Some means of minimizing these problems are (1) the concept of clinical equipoise, (2) multicenter trials, and (3) stratified sampling of patients. Alternatives to the classic RCT are discussed, namely, the randomized consent design and the patient preference design. CONCLUSIONS: The nature of the RCTs is that they are difficult to use to evaluate surgical techniques. Some options are available to minimize these difficulties. Designing and conducting RCTs to evaluate surgical interventions require careful planning and some compromises. Unless the previously mentioned criteria are applied, the validity of the RCT can be considered no greater than that of other trials.

Ethics, Medical↗
PubMed2006

Systematic review of antipsychotics for the treatment of hospital-associated delirium in medically or surgically ill patients.

OBJECTIVE: To determine which antipsychotic is associated with the greatest efficacy and safety when used for the pharmacotherapeutic management of delirium in medically or surgically ill patients. DATA SOURCES: MEDLINE, Current Contents, Cumulative Index of Nursing and Allied Health Literature, PsycINFO, Biological Abstracts, Cochrane Central Register of Controlled Trials, and EMBASE databases (all to July 2006) were searched for trials evaluating the pharmacologic treatment of delirium in medically or surgically ill patients. The key terms used included delirium, agitation, or acute confusion, and antipsychotics, phenothiazine, butyrophenone, perphenazine, fluphenazine, clozapine, trifluorophenazine, loxapine, thioridazine, pimozide, molindone, haloperidol, methotrimeprazine, chlorpromazine, prochlorperazine, droperidol, risperidone, quetiapine, ziprasidone, amisulpride, or olanzapine. STUDY SELECTION AND DATA EXTRACTION: Prospective, randomized, controlled trials comparing the clinical effects of antipsychotic therapy with placebo or comparing 2 antipsychotic treatments in an acute care setting were selected. Studies involving dementia-associated delirium, Alzheimer's disease-associated delirium, emergency department-associated acute agitation, acute brain trauma-associated agitation, or agitation secondary to underlying psychiatric afflictions such as depression or schizophrenia were excluded. All studies were evaluated independently by the 3 authors using a validated evaluation tool. Outcomes related to both efficacy and safety were collected. Four prospective trials were included in this systematic review. DATA SYNTHESIS: Antipsychotic agents, either atypical or typical, were effective compared with baseline for the treatment of delirium in medically or surgically ill patients without underlying cognitive disorders. Oral haloperidol was associated with more frequent extrapyramidal side effects, but overall, all agents were well tolerated. Interpretation of the published evidence is limited by the small sample sizes, varied patient populations, and comparative agents of the studies reviewed. CONCLUSIONS: The comparative studies evaluated here suggest that antipsychotic drugs are efficacious, when compared with baseline, and safe for the treatment of delirium. Haloperidol remains the most studied agent. Recommendation of one antipsychotic over another as a first-line pharmacologic intervention in the treatment of hospital-associated delirium is limited by the quality and quantity of data available. Better designed and larger studies evaluating the addition of antipsychotic agents to nonpharmacologic treatments are needed to measure the true effect of pharmacologic treatment.

Antipsychotic Agents↗
PubMed2005

Dopexamine and its role in the protection of hepatosplanchnic and renal perfusion in high-risk surgical and critically ill patients.

BACKGROUND: Dopexamine is increasingly being used in high-risk surgical and critically ill patients to preserve hepatosplanchnic and renal perfusion. This systematic review of randomized controlled trials was undertaken to investigate the clinical evidence for using dopexamine in this role. METHODS: Data sources included Medline, Cochrane Library, EMBASE and CINAHL and reference lists of relevant articles. Randomized controlled trials which compared dopexamine treatment with a control group, in high-risk surgical and critically ill adult patients and with primary outcome measures designed to assess hepatosplanchnic and renal perfusion were included. Articles not published in English were excluded. RESULTS: Twenty-one trials were selected from the literature search. The results suggest that dopexamine may protect against colonic mucosal damage in patients undergoing abdominal aortic surgery and may improve gastric mucosal pHi in general surgical patients, especially those with preoperative gastric mucosal pHi measurements <7.35 and those undergoing pancreatico-duodenectomy surgery. Dopexamine may have beneficial effects on renal perfusion in patients undergoing cardiac surgery but appears to have little or no benefit on gastric mucosal pHi in the same patient population. In critically ill patients none of the studies demonstrated a beneficial effect of dopexamine on either hepatosplanchnic or renal perfusion. CONCLUSION: The evidence provided by the existing studies is both inadequate and inconsistent. There is insufficient evidence to offer reliable recommendations on the clinical use of dopexamine for the protection of either hepatosplanchnic or renal perfusion in high-risk surgical patients. Furthermore, there is no current evidence to support a role for dopexamine in protecting either hepatosplanchnic or renal perfusion in critically ill patients.

Critical Illness↗
PubMed2005

Expectant, medical, or surgical management of first-trimester miscarriage: a meta-analysis.

OBJECTIVE: To quantify the relative benefits and harms of different management options for first-trimester miscarriage. DATA SOURCES: MEDLINE, EMBASE, and Cochrane Controlled Trials Register searches (1966 to July 2004), including references of retrieved articles. METHODS OF STUDY SELECTION: Randomized trials assigning women with first-trimester missed or incomplete miscarriage to surgical, medical, or expectant management were included. Primary outcomes were successful treatment and patient satisfaction. Secondary outcomes included moderate or severe bleeding, blood transfusion, emergency curettage, pelvic inflammatory disease, nausea, vomiting, and diarrhea. Comparisons used the risk difference. Between-study heterogeneity and random effects summary estimates were calculated. TABULATION, INTEGRATION, AND RESULTS: Complete evacuation of the uterus was significantly more common with surgical than medical management (risk difference 32.8%, number needed to treat 3, success rate of medical management 62%) and with medical than expectant management (risk difference 49.7%, number needed to treat 2). Success rate with expectant management was spuriously low (39%) in the latter comparison. Analysis of cases with incomplete miscarriage only showed that medical management still had two thirds the chance to induce complete evacuation compared with surgical management, but it was better than expectant management. Data from studies that evaluated outcome at 48 hours or more after allocation indicated again that medical management had a better success rate than expectant management but a worse success rate than surgical management; expectant management probably had much lower success rates than surgical evacuation, but data were very sparse. Patient satisfaction data were sparse. Moderate or severe bleeding was less common with medical than expectant management (risk difference 3.2%) and possibly surgical management (risk difference 2.1%). There was a considerable amount of missing information, in particular for secondary outcomes. CONCLUSION: One additional success can be achieved among 3 women treated surgically rather than medically. Expectant management has had remarkably variable success rates across these studies, depending probably on the type of miscarriage. Greater standardization of outcomes should be a goal of future research.

Abortifacient Agents, Nonsteroidal↗